# K911425: Accessories & Connectors, 22MM-15MM-8.5MM

- Pathway: 510(k) (Traditional)
- Applicant: Intersurgical, Inc.
- Decided: Jun 24, 1991 after 139 days
- Product code: BZA (Connector, Airway (Extension))
- Device class: 1
- Regulation: 21 CFR 868.5810
- 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 7, 2019 · Class II · Z-0785-2020: The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.
- Aug 7, 2019 · Class II · Z-0784-2020: The port may crack in the swivel elbow where the flip cap is inserted, and these cracks could possibly leak if they reach a significant size.

Source page: https://510kreport.com/device/K911425
Methodology: https://510kreport.com/methodology