# K760383: Stopcocks

- Pathway: 510(k) (Traditional)
- Applicant: B. Braun Instruments
- Decided: Nov 2, 1976 after 89 days
- Product code: KGZ (Accessories, Catheter)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: 6 (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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Oct 29, 2025 · Class II · Z-0680-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0681-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Oct 29, 2025 · Class II · Z-0679-2026: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Jan 8, 2014 · Class II · Z-0987-2014: Complaints were received reporting leakage on certain lots of SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites.The SAFSITE Injection Site is intended to provide needle fre
- Mar 27, 2009 · Not classified · Z-1432-2009: Device defect is occlusion/no flow.
- Apr 14, 2003 · Not classified · Z-0933-03: possible leakage

Source page: https://510kreport.com/device/K760383
Methodology: https://510kreport.com/methodology