Data / Medical devices / System, Peritoneal, Automatic Delivery / United States
FDA-registered makers of System, Peritoneal, Automatic Delivery in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make System, Peritoneal, Automatic Delivery (product code FKX). 9 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, Peritoneal, Automatic Delivery
- Product code
- FKX
- Country
- United States
Makers of System, Peritoneal, Automatic Delivery in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Fresenius Medical Care Renal Therapies Group, LLC | Waltham, MA, United States | Complaint file establishment, Specification developer | 10 | October 31, 2022 | 0 | 12 | 0 | api.fda.gov |
| Vantive US Healthcare LLC | Deerfield, IL, United States | Complaint file establishment, Manufacturer | 6 | November 19, 2020 | 0 | 0 | 0 | api.fda.gov |
| Vantive US Healthcare LLC | Mountain Home, AR, United States | Manufacturer | 5 | October 9, 2015 | 0 | 1 | 0 | api.fda.gov |
| Gambro UF Solutions LLC | Plymouth, MN, United States | Specification developer | 4 | October 9, 2015 | 0 | 0 | 0 | api.fda.gov |
| Byonyks Medical Devices Inc | Itasca, IL, United States | Complaint file establishment, Specification developer | 1 | May 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Gastroklenz Inc. Dba Cloudcath | San Francisco, CA, United States | Complaint file establishment, Manufacturer | 1 | February 9, 2022 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 1 | January 26, 1983 | 0 | 0 | 0 | api.fda.gov |
| R & D Batteries, Inc. | Burnsville, MN, United States | Manufacturer | 1 | February 9, 1994 | 0 | 0 | 0 | api.fda.gov |
| Simergent, LLC | Oklahoma City, OK, United States | Manufacturer | 1 | October 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maruho Plastic Solutions | Erie, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecan Cdmo Solutions MH, Corp. | Morgan Hill, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.