# K930252: Babyset and Pac (Pulmonary Assist Circuit)

- Pathway: 510(k) (Traditional)
- Applicant: Bird Life Design
- Decided: Feb 9, 1993 after 32 days
- Product code: CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece))
- Device class: 1
- Regulation: 21 CFR 868.5240
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Sep 10, 2003 · Not classified · Z-0037-04: The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
- Sep 10, 2003 · Not classified · Z-0034-04: The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
- Sep 10, 2003 · Not classified · Z-0038-04: The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
- Sep 10, 2003 · Not classified · Z-0033-04: The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
- Sep 10, 2003 · Not classified · Z-0035-04: The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.
- Sep 10, 2003 · Not classified · Z-0036-04: The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.

Source page: https://510kreport.com/device/K930252
Methodology: https://510kreport.com/methodology