# K003075: Knightstar 330 Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt, Inc.
- Decided: Dec 11, 2001 after 434 days
- Product code: MNT (Continuous, Minimal Ventilatory Support, Facility Use Ventilator)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
129 later devices descend from it; 3 cite it directly.
37 of 130 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
- K022132: Servo Ventilator System, Model 64 87 800 E407E (2002), 102 descendants of its own
- K040221: Servo-I Ventilator System, Model 64 87 800 E407E (2004), 75 descendants of its own
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E (2004), 73 descendants of its own
- K063404: Servo-I Ventilator System, Models 64, 87 and 800 (2007), 61 descendants of its own
- K040574: Galileo Gold (2004), 53 descendants of its own

## Recalls of this device
- Aug 31, 2006 · Not classified · Z-0444-2007: Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is

Source page: https://510kreport.com/device/K003075
Methodology: https://510kreport.com/methodology