# K950771: Disposable Adhesive Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Warming Systems, Inc.
- Decided: Mar 10, 1995 after 382 days
- Product code: BSJ (Mask, Gas, Anesthetic)
- Device class: 1
- Regulation: 21 CFR 868.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices 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.

## Most influential descendants
- K123176: Iso-Gard Clearair Mask (2013), 2 descendants of its own
- K132729: Iso-Gard Mask (2014), 1 descendant of its own
- K142138: Iso-Gard Mask (2014), 0 descendants of its own
- K071915: Cpap Mask (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K950771
Methodology: https://510kreport.com/methodology