# K941535: Tracheolife

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Medical
- Decided: Apr 15, 1994 after 16 days
- Product code: BYD (Condenser, Heat And Moisture (Artificial Nose))
- Device class: 1
- Regulation: 21 CFR 868.5375
- Recalls of this device: 1 (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
- Apr 29, 2021 · Class II · Z-1868-2021: The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.

Source page: https://510kreport.com/device/K941535
Methodology: https://510kreport.com/methodology