FDA product code SHP: Cardiac Amyloidosis Machine Learning-Based Notification Software
SHP is the FDA product code for cardiac amyloidosis 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 SHP, 1 in the last five years. The average 510(k) review took 130 days (median 130); 130 days on average over the last three years.
Definition
Cardiac Amyloidosis machine learning-based notification software employs machine learning techniques to suggest the likelihood of cardiac amyloidosis for further referral or diagnostic follow-up.
Classification
| Field | Value |
|---|---|
| Device name | Cardiac Amyloidosis 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 SHP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 130 |
Compare with all 510(k) review times · Search every SHP clearance
Top SHP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Anumana, Inc. | 1 | 2026-04-07 |
Most recent SHP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253801 | Anumana, Inc. | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | 2026-04-07 | 130 |
Recalls for SHP devices
openFDA lists no recalls for product code SHP.
Frequently asked questions
What is FDA product code SHP?
SHP is the FDA product code for cardiac amyloidosis 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 SHP?
Class II, regulation 21 CFR 870.2380. Typical premarket route: 510(k).
How long does a 510(k) take for product code SHP?
Across 1 cleared submissions the average was 130 days from receipt to decision (median 130).
Which companies have the most SHP clearances?
Anumana, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SHP
- Run a recall and safety report across every SHP manufacturer
- Watch product code SHP 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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