# K002001: Breeze Sleepgear with Dreamseal

- Pathway: 510(k) (Special)
- Applicant: Puritan Bennett Corp.
- Decided: Sep 6, 2000 after 68 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 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
- K013738: Weinmann Somnomask (2002), 3 descendants of its own
- K061653: Soyala Full Face Mask (2006), 2 descendants of its own
- K073673: Soyala Full Face Mask Gel Vented (2008), 1 descendant of its own
- K112167: Soyala Silkgel Full Face Mask (2011), 0 descendants of its own
- K090804: Nasal Aire II Pediatric, Model 5 Sizes, Model TBD (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K002001
Methodology: https://510kreport.com/methodology