# K961915: Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Aug 15, 1996 after 90 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K936047 (1995). 1 ancestor in all.
37 later devices descend from it; 4 cite it directly.
9 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936047: Spectrum (TM) Mask, Respironics, Inc. (1995) Summary page 1.
- (no number) Vacumed Comfo-Seal Reusable Full Face Mask: named in the summary without a submission number

## Most influential descendants
- K020759: 7600 Series Reusable Full-Face Cpap/Nippv Masks Models 7620 Large, 7630 Medium, 7640 Small, 7650 Extra Small, 7660 Petit (2002), 26 descendants of its own
- K043382: TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840 (2005), 21 descendants of its own
- K060273: Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model NO. 53837 (2006), 20 descendants of its own
- K132887: Airfit N10 (2013), 7 descendants of its own
- K153673: AirFit N20 (2016), 6 descendants of its own

## Indications for use
Patient interface accessory for Respironics CPAP and BiPAP® Systems Targeted Population -- Adult Environment of Use -- Hospital and Home

Source page: https://510kreport.com/device/K961915
Methodology: https://510kreport.com/methodology