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FDA PRODUCT CODE · CLASS II

QME — Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy.

DEVICE CLASS
Class II
REGULATION
21 CFR 870.2785
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES

Recent clearances

K254169Presage Security, Inc. d/b/a Presage Technologies, Inc. · 510k2026-06-18
K253650Nuralogix Corporation · 510k2026-06-11
K260066PanopticAI Technologies Limited · 510k2026-05-21
K251200Oxehealth Limited · 510k2026-02-02
K243687Oxehealth Limited · 510k2025-08-27
K250078Mindset Medical, Inc. · 510k2025-05-30
K240890PanopticAI technologies Limited · 510k2024-12-23
K241633Mindset Medical, Inc. · 510k2024-11-18

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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