# K900164: Airway Delivery & Management (Adam) Nasal Ventila.

- Pathway: 510(k) (Traditional)
- Applicant: Puritan Bennett Corp.
- Decided: Jan 26, 1990 after 14 days
- Product code: BYE (Attachment, Breathing, Positive End Expiratory Pressure)
- Device class: 2
- Regulation: 21 CFR 868.5965
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
107 later devices descend from it; 4 cite it directly.
10 of 108 devices 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.

## Most influential descendants
- K032433: Nasal Jacks Mask (2003), 96 descendants of its own
- K042403: Mirage Swift (2004), 80 descendants of its own
- K053352: Comfortlite Nasal Mask (2006), 41 descendants of its own
- K063122: Mirage Quattro Full Face Mask (2007), 38 descendants of its own
- K082558: Comfortlite Nasal Mask (2009), 36 descendants of its own

Source page: https://510kreport.com/device/K900164
Methodology: https://510kreport.com/methodology