Extended Life Capd Transfer Set 5C4444

510(k) K882498

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK882498	Date13 Jul 1988Cleared	StatusActive

7 recalls · FDA

- Terminated Z-2246-2017 FDA Class II initiated 28 Apr 2014
Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis.
4 recalls, same reason
- Terminated Z-2472-2015 FDA Class II initiated 25 Feb 2013
- Terminated Z-2474-2015 FDA Class II initiated 25 Feb 2013
- Terminated Z-2471-2015 FDA Class II initiated 25 Feb 2013
- Terminated Z-2473-2015 FDA Class II initiated 25 Feb 2013
Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
2 recalls, same reason
- Terminated Z-1894-2009 FDA Unclassified (pre-2012) initiated 2 Jul 2009
- Terminated Z-1893-2009 FDA Unclassified (pre-2012) initiated 2 Jul 2009
The peritoneal dialysis transfer set has a defective white sleeve twist clamp. The twist clamp will not open or close completely, which could cause leakage and lead to peritonitis.

1 jurisdiction

United States — FDA 510(k) Active

510(k)