FDA product code NPF: Monitor, Apnea, Home Use
NPF is the FDA product code for monitor, apnea, home use. It is a Class II device, regulated under 21 CFR 868.2377 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under NPF. The average 510(k) review took 87 days (median 87). FDA has posted 3 recalls for NPF devices.
Definition
Same as the identification for product code FLS, just add home use
Classification
| Field | Value |
|---|---|
| Device name | Monitor, Apnea, Home Use |
| Device class | Class II |
| Regulation | 21 CFR 868.2377 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every NPF clearance
Top NPF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Respironics, Inc. | 2 | 2006-08-02 |
Most recent NPF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K061256 | Respironics, Inc. | SMARTMONITOR 2PS | 2006-08-02 | 90 |
| K032403 | Respironics, Inc. | SMARTMONITOR 2 PROFESSIONAL SERIES (PS) | 2003-10-27 | 84 |
Recalls for NPF devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-04-29.
Frequently asked questions
What is FDA product code NPF?
NPF is the FDA product code for monitor, apnea, home use. It is a Class II device, regulated under 21 CFR 868.2377 and reviewed by the Anesthesiology panel.
What device class is NPF?
Class II, regulation 21 CFR 868.2377. Typical premarket route: 510(k).
How long does a 510(k) take for product code NPF?
Across 2 cleared submissions the average was 87 days from receipt to decision (median 87).
Which companies have the most NPF clearances?
Respironics, Inc. (2).
Have NPF devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2014-04-29.
Next steps
- Run an FDA pathway report with predicate devices for product code NPF
- Run a recall and safety report across every NPF manufacturer
- Watch product code NPF 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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