# K951264: Bipap Model S/T-D

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jul 29, 1996 after 496 days
- Product code: MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K833786 (1983). 2 ancestors in all.
85 later devices descend from it; 3 cite it directly.
14 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883825: Modified Sanders BI-Papeasy, Respironics, Inc. (1988) Summary page 1.
- K833786: Microprocessor Ventilator 7200, Puritan Bennett Corp. (1983) Summary page 1.

## Cited in the summary but kept off the family tree
- K950540: Implantable Clip, United States Surgical, A Division of Tyco Healthc (1995). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K810102: Infant Ecg Electrode #60-1029, Aspen Laboratories, Inc. (1981). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K823958: Puritan Bennett 7200. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- 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
- K082660: V60 Ventilator, Model V8000 (2009), 14 descendants of its own

## Indications for use
The BiPAP S/T-D System is intended for hospital or institutional use for treatment of obstructive sleep apnea, respiratory failure, or respiratory insufficiency.

Source page: https://510kreport.com/device/K951264
Methodology: https://510kreport.com/methodology