# K962848: Hans Rudolph Nasal Cpap Mask

- Pathway: 510(k) (Traditional)
- Applicant: Hans Rudolph, Inc.
- Decided: Oct 16, 1996 after 86 days
- Product code: BYG (Mask, Oxygen)
- Device class: 1
- Regulation: 21 CFR 868.5580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K984254: Infant Flow Ncpap Masks (1999), 2 descendants of its own
- K030563: Arabella Ncpap Masks (2003), 0 descendants of its own
- K012034: Modification to: Sipap Infant Nasal Cpap Circuit (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K962848
Methodology: https://510kreport.com/methodology