FDA product code SAR: Adjunctive Hemodynamic Indicator With Decision Point For Military Use
SAR is the FDA product code for adjunctive hemodynamic indicator with decision point for military use. It is a Class II device, regulated under 21 CFR 870.2220 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under SAR, 1 in the last five years. The average 510(k) review took 190 days (median 190); 190 days on average over the last three years.
Definition
An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information. The device is intended for use by the Military.
Classification
| Field | Value |
|---|---|
| Device name | Adjunctive Hemodynamic Indicator With Decision Point For Military Use |
| Device class | Class II |
| Regulation | 21 CFR 870.2220 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for SAR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 190 |
Compare with all 510(k) review times · Search every SAR clearance
Top SAR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Surgeon General, Department of the Army (TSG-DA) | 1 | 2024-04-05 |
Most recent SAR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233249 | The Surgeon General, Department of the Army (TSG-DA) | APPRAISE-HRI | 2024-04-05 | 190 |
Recalls for SAR devices
openFDA lists no recalls for product code SAR.
Frequently asked questions
What is FDA product code SAR?
SAR is the FDA product code for adjunctive hemodynamic indicator with decision point for military use. It is a Class II device, regulated under 21 CFR 870.2220 and reviewed by the Cardiovascular panel.
What device class is SAR?
Class II, regulation 21 CFR 870.2220. Typical premarket route: 510(k).
How long does a 510(k) take for product code SAR?
Across 1 cleared submissions the average was 190 days from receipt to decision (median 190).
Which companies have the most SAR clearances?
The Surgeon General, Department of the Army (TSG-DA) (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SAR
- Run a recall and safety report across every SAR manufacturer
- Watch product code SAR 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times