FDA product code KXP: Stent, Vaginal
KXP is the FDA product code for stent, vaginal. It is a Class II device, regulated under 21 CFR 884.3900 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 4 510(k) submissions under KXP, from 4 different applicants. The average 510(k) review took 432 days (median 168).
Classification
| Field | Value |
|---|---|
| Device name | Stent, Vaginal |
| Device class | Class II |
| Regulation | 21 CFR 884.3900 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KXP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 28 |
Compare with all 510(k) review times · Search every KXP clearance
Top KXP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pmt Corporation | 1 | 2020-09-30 |
| Owen Mumford USA, Inc. | 1 | 1998-11-25 |
| Silimed, LLC | 1 | 1998-08-05 |
| Bioteque America, Inc. | 1 | 1995-11-08 |
Most recent KXP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202542 | Pmt Corporation | Allura Vaginal Stent | 2020-09-30 | 28 |
| K983045 | Owen Mumford USA, Inc. | AMIELLE | 1998-11-25 | 85 |
| K974479 | Silimed, LLC | SILIMED VAGINAL STENT | 1998-08-05 | 252 |
| K920633 | Bioteque America, Inc. | PESSARY FLEXIBLE SILICONE NICHOLS | 1995-11-08 | 1365 |
Recalls for KXP devices
openFDA lists no recalls for product code KXP.
Frequently asked questions
What is FDA product code KXP?
KXP is the FDA product code for stent, vaginal. It is a Class II device, regulated under 21 CFR 884.3900 and reviewed by the Obstetrics and Gynecology panel.
What device class is KXP?
Class II, regulation 21 CFR 884.3900. Typical premarket route: 510(k).
How long does a 510(k) take for product code KXP?
Across 4 cleared submissions the average was 432 days from receipt to decision (median 168).
Which companies have the most KXP clearances?
Pmt Corporation (1); Owen Mumford USA, Inc. (1); Silimed, LLC (1); Bioteque America, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KXP
- Run a recall and safety report across every KXP manufacturer
- Watch product code KXP 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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