AMP Peritoneal Dialysis Prep Kit
by American Medical Products, Inc.
510(k) K810840
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810840 | Date29 Apr 1981 | 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- Withdrawn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, 6 Oct 2026
The AMP Peritoneal Dialysis Prep Kit is a disposable set for administration in peritoneal dialysis, classified as a medical device under regulation number 876.5630. It received FDA 510(k) clearance (K810840) on April 29, 1981, as substantially equivalent to a predicate device, with product code KDJ and assigned to the Gastroenterology and Urology medical specialties.
The device is supplied as a disposable, single-use kit intended for use in clinical settings preparing for peritoneal dialysis procedures. It is manufactured by American Medical Products, Inc. in McHenry, Illinois, and is not MRI safety information provided in the data. Storage conditions and specific sizes are not detailed in the supplied specifications.
Other devices from American Medical Products LLC
Questions
AI-generated answers, 6 Oct 2026
What is the AMP Peritoneal Dialysis Prep Kit used for?
The AMP Peritoneal Dialysis Prep Kit is a disposable set intended for administration in peritoneal dialysis, used to prepare for peritoneal dialysis procedures in clinical settings as a single-use device.
Is the AMP Peritoneal Dialysis Prep Kit sterile and single-use?
Yes, the AMP Peritoneal Dialysis Prep Kit is supplied as a disposable, single-use kit, meaning it is intended for one-time use only and is not designed for reuse after initial application.
Who manufactures the AMP Peritoneal Dialysis Prep Kit and where is it made?
The AMP Peritoneal Dialysis Prep Kit is manufactured by American Medical Products, Inc. in McHenry, Illinois, United States, as specified in the device authorization records.