# K003712: Modification to Male to Male Luer Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Molded Products, Inc.
- Decided: May 16, 2001 after 166 days
- Product code: KOC (Accessories, Blood Circuit, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jan 20, 2015 · Class II · Z-1679-2017: A customer relayed a complaint of a leaking dialysis tubing connector.
- Jun 19, 2012 · Class II · Z-0969-2013: The recalled product leaks at the connection site.

Source page: https://510kreport.com/device/K003712
Methodology: https://510kreport.com/methodology