FDA product code KNE: Set, Anesthesia, Obstetric
KNE is the FDA product code for set, anesthesia, obstetric. It is a Class II device, regulated under 21 CFR 884.5100 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under KNE, from 2 different applicants. The average 510(k) review took 50 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Set, Anesthesia, Obstetric |
| Device class | Class II |
| Regulation | 21 CFR 884.5100 |
| 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 KNE clearance
Top KNE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1988-06-01 |
| Hdc Corp. | 1 | 1986-07-07 |
Most recent KNE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880988 | Bd Becton Dickinson Vacutainer Systems Preanalytic | PUDENDAL/LOCAL ANESTESIA BLOCK TRAY | 1988-06-01 | 85 |
| K862358 | Hdc Corp. | EPICATH | 1986-07-07 | 14 |
Recalls for KNE devices
openFDA lists no recalls for product code KNE.
Frequently asked questions
What is FDA product code KNE?
KNE is the FDA product code for set, anesthesia, obstetric. It is a Class II device, regulated under 21 CFR 884.5100 and reviewed by the Obstetrics and Gynecology panel.
What device class is KNE?
Class II, regulation 21 CFR 884.5100. Typical premarket route: 510(k).
How long does a 510(k) take for product code KNE?
Across 2 cleared submissions the average was 50 days from receipt to decision (median 50).
Which companies have the most KNE clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Hdc Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KNE
- Run a recall and safety report across every KNE manufacturer
- Watch product code KNE 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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