FDA product code SFR: Hypertension Machine Learning-Based Notification Software
SFR is the FDA product code for hypertension machine learning-based notification software. It is a Class II device, regulated under 21 CFR 870.2380 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under SFR, 1 in the last five years. The average 510(k) review took 202 days (median 202); 202 days on average over the last three years.
Definition
Hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of hypertension for further referral or diagnostic follow-up.
Classification
| Field | Value |
|---|---|
| Device name | Hypertension Machine Learning-Based Notification Software |
| Device class | Class II |
| Regulation | 21 CFR 870.2380 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for SFR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 202 |
Compare with all 510(k) review times · Search every SFR clearance
Top SFR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Apple, Inc. | 1 | 2025-09-11 |
Most recent SFR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250507 | Apple, Inc. | Hypertension Notification Feature (HTNF) | 2025-09-11 | 202 |
Recalls for SFR devices
openFDA lists no recalls for product code SFR.
Frequently asked questions
What is FDA product code SFR?
SFR is the FDA product code for hypertension machine learning-based notification software. It is a Class II device, regulated under 21 CFR 870.2380 and reviewed by the Cardiovascular panel.
What device class is SFR?
Class II, regulation 21 CFR 870.2380. Typical premarket route: 510(k).
How long does a 510(k) take for product code SFR?
Across 1 cleared submissions the average was 202 days from receipt to decision (median 202).
Which companies have the most SFR clearances?
Apple, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SFR
- Run a recall and safety report across every SFR manufacturer
- Watch product code SFR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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