Cleared Traditional

K241090 - Evie Med Ring (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K241090 · Movano Inc. Dba Movano Health · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Nov 2024
Decision
221d
Days
Class 2
Risk

K241090 is an FDA 510(k) clearance for the Evie Med Ring. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Movano Inc. Dba Movano Health (Pleasanton, US). The FDA issued a Cleared decision on November 29, 2024 after a review of 221 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Movano Inc. Dba Movano Health devices

Submission Details

510(k) Number K241090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2024
Decision Date November 29, 2024
Days to Decision 221 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 139d · This submission: 221d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05920278 Completed Observational Industry-sponsored

Accuracy of Pulse Oximeters in Profound Hypoxia

Performance of the Movano Health Ring in a Controlled Hypoxia Study: Prospective Observational Study

11
Patients (actual)
1
Site
Condition studied Hypoxia
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Phillip E Bickler, MD, PhD
Sponsor Movano Health (industry)
Started 2022-10-26 → Primary completion 2022-10-27
Primary outcome
RMSE compared to arterial blood SaO2
Study completed - no results published. This trial concluded in 2022 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - DQA Oximeter

All 723
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K241090.
Nasal Alar SpO2 Sensor (989803205381)
K253887 · Philips Medizin Systeme · May 2026
Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)
K260931 · Unimed Medical Supplies, Inc. · Apr 2026
AViTA Pulse Oximeter (SP61)
K252448 · Avita Corporation · Feb 2026
YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
K252805 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Feb 2026
Reusable SPO2 Sensor (BSA307-47
K253109 · Shenzhen Best Electronics Co., Ltd. · Jan 2026
Spo2 Sensor CSS032D
K251751 · Shenzhen Ykd Technology Co., Ltd. · Dec 2025