CAPD Safe Lock Transfer Set
by American Medical Products, Inc.
510(k) K822543
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822543 | Date13 Oct 1982 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FKX
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5630
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The CAPD Safe Lock Transfer Set is a System, Peritoneal, Automatic Delivery device designed for continuous ambulatory peritoneal dialysis (CAPD). It facilitates the safe transfer of dialysis solutions between a peritoneal dialysis bag and the patient’s peritoneal cavity, ensuring sterile and controlled fluid exchange during treatment. The set includes components that connect to the patient’s catheter, allowing for secure and contamination-free fluid transfer while minimizing the risk of infection or leakage.
This device is supplied as a single-use, sterile set and is intended for use in clinical settings such as hospitals, dialysis centers, and home care environments. It is classified under FDA regulation 876.5630 and has received FDA 510(k) clearance (K822543) as substantially equivalent to a predicate device. The set is not MRI-compatible and must be handled with sterile technique to prevent contamination. Storage instructions are not specified in the data, but standard sterile medical device storage practices apply.
Other devices from American Medical Products LLC
Questions
AI-generated answers, 1 Oct 2026
What is the CAPD Safe Lock Transfer Set used for?
The CAPD Safe Lock Transfer Set is designed specifically for continuous ambulatory peritoneal dialysis (CAPD). It facilitates the safe transfer of dialysis solutions between a peritoneal dialysis bag and the patient’s peritoneal cavity, ensuring sterile and controlled fluid exchange. This minimizes the risk of infection or leakage during treatment, making it ideal for clinical settings like hospitals, dialysis centers, and home care environments.
Is the CAPD Safe Lock Transfer Set single-use or reusable?
The CAPD Safe Lock Transfer Set is intended for single-use only. This design ensures sterility and reduces the risk of contamination between patients, adhering to best practices for medical devices used in peritoneal dialysis.
What components does the set include, and how is it connected to the patient?
The CAPD Safe Lock Transfer Set includes components that connect directly to the patient’s peritoneal dialysis catheter. These components are engineered to provide a secure, contamination-free connection between the dialysis bag and the patient’s peritoneal cavity, ensuring safe fluid transfer during CAPD treatment.
Are there different sizes or models of this transfer set?
The CAPD Safe Lock Transfer Set is available in multiple product codes (e.g., FKX), which may correspond to variations in tubing lengths, connectors, or other minor specifications. However, the core function and design remain consistent across these models to ensure compatibility with standard peritoneal dialysis catheters. For exact sizing or model-specific details, refer to the manufacturer’s packaging or documentation.
How should the CAPD Safe Lock Transfer Set be stored?
While specific storage instructions are not detailed in the provided data, standard sterile medical device storage practices apply. The set should be stored in a clean, dry environment, protected from moisture, direct sunlight, and extreme temperatures. Ensure the packaging remains intact until immediate use to maintain sterility.