# K842829: High Pressure, 1 & 3 Way Sterile Dispos

- Pathway: 510(k) (Traditional)
- Applicant: North American Instrument Corp.
- Decided: Oct 18, 1984 after 90 days
- Product code: DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4290
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- 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.

Source page: https://510kreport.com/device/K842829
Methodology: https://510kreport.com/methodology