FDA product code NPP: Reprocessed Blood Pressure Cuff
NPP is the FDA product code for reprocessed blood pressure cuff. It is a Class II device, regulated under 21 CFR 870.1120 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under NPP. The average 510(k) review took 91 days (median 91).
Definition
The intended use for the reprocessed/reused blood pressure cuff is use in manual measurement and automatic non-invasive blood pressure monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual bp measurement.
Classification
| Field | Value |
|---|---|
| Device name | Reprocessed Blood Pressure Cuff |
| Device class | Class II |
| Regulation | 21 CFR 870.1120 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NPP clearance
Top NPP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hygia Health Services, Inc. | 1 | 2003-12-05 |
Most recent NPP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K032821 | Hygia Health Services, Inc. | HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF | 2003-12-05 | 91 |
Recalls for NPP devices
openFDA lists no recalls for product code NPP.
Frequently asked questions
What is FDA product code NPP?
NPP is the FDA product code for reprocessed blood pressure cuff. It is a Class II device, regulated under 21 CFR 870.1120 and reviewed by the Cardiovascular panel.
What device class is NPP?
Class II, regulation 21 CFR 870.1120. Typical premarket route: 510(k).
How long does a 510(k) take for product code NPP?
Across 1 cleared submissions the average was 91 days from receipt to decision (median 91).
Which companies have the most NPP clearances?
Hygia Health Services, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NPP
- Run a recall and safety report across every NPP manufacturer
- Watch product code NPP 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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