# K000705: Respironics Silhouette Nasal Mask, Models 1003224 and 1003223

- Pathway: 510(k) (Abbreviated)
- Applicant: Respironics, Inc.
- Decided: Sep 8, 2000 after 190 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.
9 later devices descend from it; 2 cite it directly.
1 of 10 devices in its family (counting itself) has 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
- K063268: Cpap/Vpap Masks, Models 1225, 1205 and 1235 (2007), 4 descendants of its own
- K103174: Apex Medical Wizard Series Cpap Mask (2011), 3 descendants of its own
- K182394: WiZARD 310/320 Series CPAP Mask (2019), 1 descendant of its own
- K120920: Hsiner Cpap Silicone Nasal Mask Size XS/Petite  Hsiner Nasal Pillow Mask Hsiner Infant Cpap Cannula (2012), 1 descendant of its own
- K243023: WiZARD 520 Full Face Mask (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K000705
Methodology: https://510kreport.com/methodology