Peritoneal Dialysis Cycler Set W/Pump
by American Medical Products, Inc.
510(k) K801220
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801220 | Date12 Aug 1980 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KDJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5630
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Peritoneal Dialysis Cycler Set With Pump is a disposable administration set designed for use in peritoneal dialysis. It functions as a component for the delivery of dialysis fluids during the automated treatment process.
This device is supplied as a single-use disposable set and is regulated under FDA 510(k) clearance K801220. It is classified as a class 2 medical device under regulation number 876.5630.
Other devices from American Medical Products LLC
Questions
AI-generated answers, 25 Sep 2026
What is the primary function of this cycler set?
This device is designed to serve as an administration set for the delivery of dialysis fluids during the automated peritoneal dialysis treatment process.
Is this device intended for multiple uses?
No, this is a single-use disposable set. It is designed to be used once to ensure the safety and integrity of the dialysis fluid delivery process.
What is the regulatory status of this device?
This device is regulated under FDA 510(k) clearance K801220 and is classified as a class 2 medical device under regulation number 876.5630.