# K973004: Knightstar 335

- Pathway: 510(k) (Traditional)
- Applicant: Puritan Bennett Corp.
- Decided: Jul 16, 1998 after 337 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: 3 generations back to K833786 (1983). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955324: Bipap S/T-D 30 System, Respironics, Inc. (1996) Summary page 1.

## Indications for use
The Nellcor Puritan Bennett KnightStar 335 is indicated for use in treating spontaneously breathing patients over 30 Kg with obstructive sleep apnea or respiratory insufficiency in a homecare, hospital or institutional environment. In addition, when used with a Control Module Type 1 and an airway pressure monitor, it is indicated for use in treating spontaneously breathing patients over 30 Kg with respiratory failure in a hospital or institutional environment.

Source page: https://510kreport.com/device/K973004
Methodology: https://510kreport.com/methodology