Data / Medical devices / Shunt, Peritoneal
Shunt, Peritoneal (KPM): 4 FDA-registered makers in 1 country
4 establishments in 1 country are registered with the FDA to make Shunt, Peritoneal (product code KPM, Class 2, 21 CFR 876.5955). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on August 18, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KPM
- Device class
- 2
- Regulation
- 876.5955
- Medical specialty
- Gastroenterology, Urology
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
Makers of Shunt, Peritoneal
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Carefusion 2200, Inc. | Vernon Hills, IL, United States | Complaint file establishment, Specification developer | 3 | November 2, 2017 | 0 | 0 | 0 | api.fda.gov |
| Pleural Dynamics, Inc. | Minnetonka, MN, United States | Complaint file establishment, Specification developer | 1 | August 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| Carefusion 2200, Inc. | Mannford, OK, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kuro Medical | Eden Prairie, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 18, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.