# K955324: Bipap S/T-D 30 System

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Dec 20, 1996 after 396 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: 2 generations back to K833786 (1983). 6 ancestors in all.
44 later devices descend from it; 2 cite it directly.
9 of 51 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.
- K951264: Bipap Model S/T-D, Respironics, Inc. (1996). Cleared while this submission was under review Summary page 1.
- K905540: Respironics Bipap Remote Control Unit, Respironics, Inc. (1991) Summary page 1.
- K811102: Siemens-Elema AB Servo Ventilator 900 C, Siemens Elema AB (1981) Summary page 1.
- K950331: Pressure Support Ventilatory Assist System (Psvas), Healthdyne, Inc. (1995) Summary page 1.

## Most influential descendants
- K982454: Bipap Vision Ventilatory Support (1998), 42 descendants of its own
- K082660: V60 Ventilator, Model V8000 (2009), 14 descendants of its own
- K053168: Bipap Focus (2006), 11 descendants of its own
- K071560: Provent Nasal Dilator, Model BR2 (2008), 10 descendants of its own
- K113053: Bipap a 30 Ventilatory Support System (2012), 8 descendants of its own

## Indications for use
The BiPAP S/T-D 30 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/K955324
Methodology: https://510kreport.com/methodology