Device class
Class II
Regulation 870.2785
Total clearances
13
2021-03-26 → 2026-06-18
Definition
What is 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.
Classification details
Medical specialty
Cardiovascular
Regulation number
870.2785
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Oxehealth Limited
|
5 |
1 |
2026-02-02 |
|
PanopticAI technologies Limited |
2 |
1 |
2026-05-21 |
|
Mindset Medical, Inc. |
2 |
0 |
2025-05-30 |
|
Qompium NV |
1 |
0 |
2024-06-07 |
|
Presage Security, Inc. d/b/a Presage Technologies, Inc. |
1 |
1 |
2026-06-18 |
|
Nuralogix Corporation |
1 |
1 |
2026-06-11 |
|
Faceheart Corp. |
1 |
0 |
2023-09-01 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 93000 |
CPT
|
— |
Medium
|
Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only |
| 99457 |
CPT
|
— |
Medium
|
Remote monitoring of physiologic parameters (e.g., vital signs); setup and patient education |
| A4305 |
HCPCS
|
Disposable drug delivery system, flow rate of 50 ml or greater per hour ✓ CMS-verified description |
Low
|
Wrist-worn pulse oximetry sensor for remote monitoring applications |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-06-18 |
K254169 |
Presage Security, Inc. d/b/a Presage Technologies, Inc.
|
SmartSpectra Vital Signs Monitor 1.0 |
| 2026-06-11 |
K253650 |
Nuralogix Corporation
|
Anura Mobile Core SDK (M1) |
| 2026-05-21 |
K260066 |
PanopticAI Technologies Limited
|
PanopticAI Vital Signs (1.6.1-22) |
| 2026-02-02 |
K251200 |
Oxehealth Limited
|
Vital Signs |
| 2025-08-27 |
K243687 |
Oxehealth Limited
|
Vital Signs |
| 2025-05-30 |
K250078 |
Mindset Medical, Inc.
|
Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) |
| 2024-12-23 |
K240890 |
PanopticAI technologies Limited
|
PanopticAI Vital Signs |
| 2024-11-18 |
K241633 |
Mindset Medical, Inc.
|
Informed Vital Core Application (IVC App) |
| 2024-06-07 |
K232804 |
Qompium NV
|
FibriCheck |
| 2023-09-01 |
K223622 |
Faceheart Corp.
|
FaceHeart Vitals Software Development Kit (FH vitals SDK) |
| 2022-04-29 |
K220899 |
Oxehealth Limited
|
Oxehealth Vital Signs |
| 2021-07-20 |
K211906 |
Oxehealth Limited
|
Vital Signs |
| 2021-03-26 |
DEN200019 |
Oxehealth Limited
|
Oxehealth Vital Signs |