FDA product code PKN: Dilator, Cervical, Synthetic, Osmotic
PKN is the FDA product code for dilator, cervical, synthetic, osmotic. It is a Class II device, regulated under 21 CFR 884.4260 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under PKN. The average 510(k) review took 136 days (median 136).
Definition
Cervical softening and dilation
Classification
| Field | Value |
|---|---|
| Device name | Dilator, Cervical, Synthetic, Osmotic |
| Device class | Class II |
| Regulation | 21 CFR 884.4260 |
| 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 PKN clearance
Top PKN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medicem Technology S.R.O | 1 | 2015-04-17 |
Most recent PKN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143447 | Medicem Technology S.R.O | Dilapan-S | 2015-04-17 | 136 |
Recalls for PKN devices
openFDA lists no recalls for product code PKN.
Frequently asked questions
What is FDA product code PKN?
PKN is the FDA product code for dilator, cervical, synthetic, osmotic. It is a Class II device, regulated under 21 CFR 884.4260 and reviewed by the Obstetrics and Gynecology panel.
What device class is PKN?
Class II, regulation 21 CFR 884.4260. Typical premarket route: 510(k).
How long does a 510(k) take for product code PKN?
Across 1 cleared submissions the average was 136 days from receipt to decision (median 136).
Which companies have the most PKN clearances?
Medicem Technology S.R.O (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PKN
- Run a recall and safety report across every PKN manufacturer
- Watch product code PKN 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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