# K782095: Stopcocks, Manifolds

- Pathway: 510(k) (Traditional)
- Applicant: Namic
- Decided: Jan 23, 1979 after 36 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- Recalls of this device: 7 (3 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.
1 of 1 device in its family (counting itself) has 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
- Mar 24, 2026 · Class I · Z-2139-2026: Medline has identified the presence of particulate within the fluid path of the Manifolds.
- Mar 24, 2026 · Class I · Z-2140-2026: Medline has identified the presence of particulate within the fluid path of the Manifolds.
- Mar 24, 2026 · Class I · Z-2138-2026: Medline has identified the presence of particulate within the fluid path of the Manifolds.
- Aug 6, 2021 · Class II · Z-2574-2021: Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
- Aug 6, 2021 · Class II · Z-2575-2021: Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
- Aug 6, 2008 · Not classified · Z-0287-2009: Firm became aware that a specific batch of the product may contain loose plastic particulates in the fluid pathway.
- May 5, 2004 · Not classified · Z-1393-05: Molded handles used in Angiographic Manifolds may be occluded.

Source page: https://510kreport.com/device/K782095
Methodology: https://510kreport.com/methodology