FDA product code KPM: Shunt, Peritoneal
KPM is the FDA product code for shunt, peritoneal. It is a Class II device, regulated under 21 CFR 876.5955 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 19 510(k) submissions under KPM, 1 in the last five years, from 9 different applicants. The average 510(k) review took 147 days (median 89).
Classification
| Field | Value |
|---|---|
| Device name | Shunt, Peritoneal |
| Device class | Class II |
| Regulation | 21 CFR 876.5955 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KPM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 265 |
| 2023 | 1 | 122 |
Compare with all 510(k) review times · Search every KPM clearance
Top KPM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Denver Biomedicals, Inc. | 6 | 2001-06-01 |
| Codman & Shurtleff, Inc. | 3 | 1989-09-29 |
| Denver Biomedical, Inc. | 2 | 2001-10-04 |
| Denver Biomaterials, Inc. | 2 | 1998-03-17 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 2 | 1990-08-21 |
4 more applicants have KPM clearances. See the full list in Caduvo.
Most recent KPM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231096 | Pleural Dynamics, Inc. | Automatic Continuous Effusion Shunt (ACES) System ACES System | 2023-08-18 | 122 |
| K170405 | Care Fusion | BD Curve Ascites Shunt | 2017-11-02 | 265 |
| K012235 | Denver Biomedical, Inc. | DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | 2001-10-04 | 79 |
| K011862 | Denver Biomedical, Inc. | DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT | 2001-07-12 | 28 |
| K011020 | Denver Biomedicals, Inc. | DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER | 2001-06-01 | 58 |
Recalls for KPM devices
openFDA lists no recalls for product code KPM.
Frequently asked questions
What is FDA product code KPM?
KPM is the FDA product code for shunt, peritoneal. It is a Class II device, regulated under 21 CFR 876.5955 and reviewed by the Gastroenterology and Urology panel.
What device class is KPM?
Class II, regulation 21 CFR 876.5955. Typical premarket route: 510(k).
How long does a 510(k) take for product code KPM?
Across 19 cleared submissions the average was 147 days from receipt to decision (median 89).
Which companies have the most KPM clearances?
Denver Biomedicals, Inc. (6); Codman & Shurtleff, Inc. (3); Denver Biomedical, Inc. (2); Denver Biomaterials, Inc. (2); Bd Becton Dickinson Vacutainer Systems Preanalytic (2).
Next steps
- Run an FDA pathway report with predicate devices for product code KPM
- Run a recall and safety report across every KPM manufacturer
- Watch product code KPM 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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