# K954207: Gel Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jan 31, 1996 after 146 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 3 cite it directly.
3 of 23 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
- K073600: Comfortgel Full Face Mask (2008), 20 descendants of its own
- K092835: Comfortgel Nasal Mask (2010), 10 descendants of its own
- K090935: Minime Pediatric Mask (2009), 5 descendants of its own
- K110405: Trublue Nasal Mask (2011), 4 descendants of its own
- K122847: Kangaroo Nasal Mask (2013), 3 descendants of its own

## Recalls of this device
- Oct 15, 2007 · Not classified · Z-1071-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1079-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Oct 15, 2007 · Not classified · Z-1073-2008: Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- Sep 29, 2003 · Not classified · Z-0178-04: product does not contain built in exhalation port

Source page: https://510kreport.com/device/K954207
Methodology: https://510kreport.com/methodology