FDA product code KNP: Orthosis, Corrective Shoe
KNP is the FDA product code for orthosis, corrective shoe. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel. FDA has cleared 7 510(k) submissions under KNP, from 6 different applicants. The average 510(k) review took 23 days (median 24).
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Corrective Shoe |
| Device class | Class I |
| Regulation | 21 CFR 890.3475 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KNP clearance
Top KNP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fred Sammons, Inc. | 2 | 1983-06-08 |
| Ipos Luneburg | 1 | 1983-06-24 |
| Warm & Form, Orthopedic Materials | 1 | 1982-12-30 |
| Hamilton Kent | 1 | 1981-02-10 |
| Alimed, Inc. | 1 | 1980-08-07 |
1 more applicants have KNP clearances. See the full list in Caduvo.
Most recent KNP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831690 | Ipos Luneburg | IPOS ANTI-ADDUCTUS SHOE | 1983-06-24 | 31 |
| K831552 | Fred Sammons, Inc. | SORBOTHANE VISCO INNER SOLE PAD | 1983-06-08 | 27 |
| K823654 | Fred Sammons, Inc. | SLIP-ON SANDALS FOR MEASURING SHORTNESS | 1983-01-21 | 46 |
| K823665 | Warm & Form, Orthopedic Materials | ROTATION BOOT | 1982-12-30 | 24 |
| K810228 | Hamilton Kent | SORBOTHANE | 1981-02-10 | 14 |
Recalls for KNP devices
openFDA lists no recalls for product code KNP.
Frequently asked questions
What is FDA product code KNP?
KNP is the FDA product code for orthosis, corrective shoe. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel.
What device class is KNP?
Class I, regulation 21 CFR 890.3475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KNP?
Across 7 cleared submissions the average was 23 days from receipt to decision (median 24).
Which companies have the most KNP clearances?
Fred Sammons, Inc. (2); Ipos Luneburg (1); Warm & Form, Orthopedic Materials (1); Hamilton Kent (1); Alimed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KNP
- Run a recall and safety report across every KNP manufacturer
- Watch product code KNP 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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