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RingConn wins FDA clearance for blood oxygen monitoring on its smart ring

RingConn wins FDA clearance for blood oxygen monitoring on its smart ring

Rule Changes

RingConn says it is the first Chinese smart ring maker to clear FDA review for blood oxygen, but its sleep apnea feature is still a wellness tool

October 10th, 2026: RingConn announces FDA SpO2 clearance

Overview

Updated Oct 26

RingConn won FDA clearance on Oct. 2 to measure blood oxygen on a smart ring, which the company called a first for a Chinese maker. The agency's listing shows Shenzhen Ninenovo Technology filed the application on Feb. 13, 2026, and got a decision about eight months later under clearance No. K260490.

The clearance names one device: the Ninenovo Blood Oxygen Ring, models BORMB-01-6 through BORMB-01-14, a Class II oximeter. The listing does not say which RingConn generation it matches, and it covers oxygen measurement only, not the sleep apnea or vascular features in the app. RingConn markets those as general wellness tools that cannot diagnose disease, and says it expects an FDA decision on sleep apnea monitoring by the end of 2026.

Why it matters

With FDA clearance, a smart ring's blood oxygen reading becomes medical data, usable by clinicians instead of just a fitness metric.

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Key Indicators

BORMB-01-6 to -14
Cleared device models
The FDA clearance covers nine model variants of the Ninenovo Blood Oxygen Ring, a Class II oximeter (product code DQA). The listing does not say which RingConn generation it matches.
Feb 13 → Oct 2
FDA review span
Shenzhen Ninenovo filed the 510(k) application on Feb. 13, 2026; the FDA decided it on Oct. 2, roughly eight months later.

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Organizations Involved

RingConn (Shenzhen Ninenovo Technology Limited)
RingConn (Shenzhen Ninenovo Technology Limited)
Consumer technology company
Holds FDA 510(k) clearance for the Ninenovo Blood Oxygen Ring oximeter; its sleep apnea feature is not FDA-cleared

Chinese smart ring maker that won FDA clearance for a blood oxygen ring in October 2026.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal regulator
Regulator that granted the 510(k) clearance

U.S. agency that grants 510(k) clearance to devices shown substantially equivalent to legally marketed predicates.

Timeline

February 2026 October 2026

5 events Latest: October 10th, 2026 · 1 month ago
Tap a bar to jump to that date

  1. RingConn announces FDA SpO2 clearance

    Latest Regulatory

    RingConn says the FDA granted 510(k) clearance No. K260490 for non-invasive blood oxygen measurement on Oct. 2. The company called it a first for a Chinese smart ring maker.

  2. FDA clears Ninenovo Blood Oxygen Ring for SpO2

    Regulatory

    FDA issued 510(k) clearance No. K260490 for the Ninenovo Blood Oxygen Ring (models BORMB-01-6 through BORMB-01-14), a Class II oximeter under product code DQA. RingConn announced the decision Oct. 10.

  3. RingConn Gen 3 launches globally

    Product

    The Gen 3 smart ring ships worldwide, with over $10 million in sales within its first 20 days.

  4. RingConn opens Gen 3 pre-orders

    Product

    RingConn begins taking pre-orders for its Gen 3 smart ring, which tracks blood oxygen, sleep apnea, heart rate, and stress.

  5. RingConn files 510(k) for blood oxygen ring

    Regulatory

    Shenzhen Ninenovo Technology submits the application that becomes K260490, according to FDA listing data. The agency decided it on Oct. 2, about eight months later.

Scenarios

1

RingConn wins FDA clearance for sleep apnea feature by year end

Likely Resolves by End of 2026

Discussed by: RingConn's stated expectation; reported by Sleep Review

RingConn has submitted its ring's pulse oximeter and sleep apnea monitoring features for FDA review and said it expects decisions by the end of 2026. The SpO2 clearance just granted gives the company a working template for what FDA reviewers accept. A sleep apnea clearance would let the ring flag potential sleep-disordered breathing episodes, moving it further into diagnostic territory.

2

FDA's skin-tone pulse oximetry review tightens requirements

Possible Resolves by Q2 2027

Discussed by: FDA's ongoing accuracy review; reported by Regulatory News

The FDA has been reviewing pulse oximeter accuracy across skin pigmentation after published research found positive bias, overestimating blood oxygen saturation, in patients with darker skin. New special controls or testing requirements for the optical sensors RingConn uses would affect the cleared device and every competitor relying on the same principle. The classification order that created RingConn's regulatory path does not resolve this open question.

3

A rival smart ring maker files for its own FDA clearance

Possible Resolves by End of 2027

Discussed by: Regulatory pathway described by Regulatory News

RingConn's clearance creates a predicate that other smart ring makers can cite in their own 510(k) filings, shortening the path to market. The same mechanism converted Masimo's one-off De Novo grant into a standing Class II category competitors now use. A wearable maker seeking medical standing for its SpO2 readings would need its own clearance, and RingConn's approval lowers that barrier.

4

Samsung clears sleep apnea risk detection before RingConn

Likely Resolves by End of 2026

Discussed by: Samsung's Galaxy Unpacked announcement, reported by Android Authority and Gizmodo; Ring & Rest

Samsung said at Galaxy Unpacked in July 2026 that the Galaxy Ring will be 'the first and only FDA-cleared over-the-counter ring device for sleep apnea risk detection,' with Gizmodo reporting arrival later in fall 2026. Samsung's newsroom already describes an FDA-authorized sleep apnea feature for its Galaxy Watch. If Samsung's ring clearance lands before RingConn's pending sleep apnea decision, the first-cleared-for-apnea claim goes to Samsung despite RingConn's earlier SpO2 clearance.

5

RingConn pursues European medical certification for the ring

Possible Resolves by End of 2027

Discussed by: Norseman Projects analysis of the clearance

A 510(k) carries no weight with European regulators. RingConn lists CE among its certifications but does not describe it as medical device certification, so selling the blood oxygen function as a medical device in the EU would need a separate certificate under the EU's device rules. The company has announced no such filing.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

September 2018

Apple Watch ECG (2018)

Apple's Series 4 Watch became the first consumer wearable to gain FDA clearance for an electrocardiogram (ECG) app and irregular heart rhythm notification. The agency granted it via De Novo authorization, a path for novel devices with no existing predicate.

Then

Set a template for consumer devices carrying medical-grade diagnostic features through FDA review.

Now

Opened the door for wearables like smart rings to pursue similar clearances for optical sensors.

Why this matters now

Showed a consumer wearable could cross into FDA-cleared medical territory, the same door RingConn is now walking through with an optical sensor.

October 2023 – October 2026

Masimo ORi De Novo and hyperoxia Class II (2023–2026)

FDA granted De Novo authorization to Masimo's Oxygen Reserve Index (ORi), a pulse oximetry adjunct for monitoring elevated hemoglobin oxygen saturation during surgery. On Oct. 6, 2026, the agency classified the device type as Class II, creating a predicate competitors can cite in ordinary 510(k) filings.

Then

Competitors no longer need their own De Novo reviews for hyperoxia monitoring devices.

Now

Lowered the regulatory barrier for pulse-oximetry-adjacent devices, the same machinery RingConn used for its SpO2 clearance.

Why this matters now

Illustrates how a single FDA approval converts into a standing regulatory category, exactly what RingConn's clearance now provides for smart ring blood oxygen.

Sources

(12)
+6
PR Newswire ifeng.com Regulatory News Sleep Review PharmaDeviceNews 510k Database Ring & Rest Smart Watch Life Norseman Projects PR Newswire PR Newswire Ring & Rest