# K911780: Infant Nasal Cannulae Assembly, Modified

- Pathway: 510(k) (Traditional)
- Applicant: Ackrad Laboratories
- Decided: Jun 24, 1991 after 63 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 2 (2 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Aug 11, 2026 · Class I · Z-3140-2026: Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectivene
- Aug 11, 2026 · Class I · Z-3139-2026: Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectivene

Source page: https://510kreport.com/device/K911780
Methodology: https://510kreport.com/methodology