# K883825: Modified Sanders BI-Papeasy

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Dec 8, 1988 after 90 days
- Product code: BYE (Attachment, Breathing, Positive End Expiratory Pressure)
- Device class: 2
- Regulation: 21 CFR 868.5965
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
89 later devices descend from it; 5 cite it directly.
14 of 90 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
- K951264: Bipap Model S/T-D (1996), 85 descendants of its own
- K991648: Reusable Contour II Nasal Mask (1999), 58 descendants of its own
- K955324: Bipap S/T-D 30 System (1996), 44 descendants of its own
- K982454: Bipap Vision Ventilatory Support (1998), 42 descendants of its own
- K071509: Bipap Synchrony 2 Ventilatory Support System (2007), 28 descendants of its own

Source page: https://510kreport.com/device/K883825
Methodology: https://510kreport.com/methodology