# K002465: Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Sep 8, 2000 after 28 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
No predicates in its family tree.
75 later devices descend from it; 10 cite it directly.
13 of 76 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
- K023135: IMAGE3 SE Disposable Full Face Mask (2003), 28 descendants of its own
- K043382: TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840 (2005), 21 descendants of its own
- K073600: Comfortgel Full Face Mask (2008), 20 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
- K092835: Comfortgel Nasal Mask (2010), 10 descendants of its own

Source page: https://510kreport.com/device/K002465
Methodology: https://510kreport.com/methodology