FDA product code KNB: Instrument, Destructive, Fetal, Obstetric
KNB is the FDA product code for instrument, destructive, fetal, obstetric. It is a Class II device, regulated under 21 CFR 884.4500 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under KNB. The average 510(k) review took 21 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Destructive, Fetal, Obstetric |
| Device class | Class II |
| Regulation | 21 CFR 884.4500 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KNB clearance
Top KNB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Medical Products | 1 | 1989-02-13 |
Most recent KNB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890388 | Kinetic Medical Products | CEPHALOTOMY SCISSORS | 1989-02-13 | 21 |
Recalls for KNB devices
openFDA lists no recalls for product code KNB.
Frequently asked questions
What is FDA product code KNB?
KNB is the FDA product code for instrument, destructive, fetal, obstetric. It is a Class II device, regulated under 21 CFR 884.4500 and reviewed by the Obstetrics and Gynecology panel.
What device class is KNB?
Class II, regulation 21 CFR 884.4500. Typical premarket route: 510(k).
How long does a 510(k) take for product code KNB?
Across 1 cleared submissions the average was 21 days from receipt to decision (median 21).
Which companies have the most KNB clearances?
Kinetic Medical Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KNB
- Run a recall and safety report across every KNB manufacturer
- Watch product code KNB 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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