FDA product code KNM: Device, Pressure Applying
KNM is the FDA product code for device, pressure applying. It is a Class I device, regulated under 21 CFR 890.5765 and reviewed by the Physical Medicine panel. FDA has cleared 2 510(k) submissions under KNM. The average 510(k) review took 36 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Device, Pressure Applying |
| Device class | Class I |
| Regulation | 21 CFR 890.5765 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KNM clearance
Top KNM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Autonomic Equipment Supply Co, | 2 | 1981-07-31 |
Most recent KNM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K811956 | Autonomic Equipment Supply Co, | AUTONORM & NERV-A-NORM | 1981-07-31 | 22 |
| K780312 | Autonomic Equipment Supply Co, | AUTONOM | 1978-04-05 | 49 |
Recalls for KNM devices
openFDA lists no recalls for product code KNM.
Frequently asked questions
What is FDA product code KNM?
KNM is the FDA product code for device, pressure applying. It is a Class I device, regulated under 21 CFR 890.5765 and reviewed by the Physical Medicine panel.
What device class is KNM?
Class I, regulation 21 CFR 890.5765. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KNM?
Across 2 cleared submissions the average was 36 days from receipt to decision (median 36).
Which companies have the most KNM clearances?
Autonomic Equipment Supply Co, (2).
Next steps
- Run an FDA pathway report with predicate devices for product code KNM
- Run a recall and safety report across every KNM manufacturer
- Watch product code KNM 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 Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times