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Knightstar 330 Ventilator

by Mallinckrodt, Inc.

510(k) K003075

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)ST Traditional NumberK003075 Date11 Dec 2001DecidedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0444-2007 FDA Unclassified (pre-2012) initiated 31 Aug 2006

    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 in use.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MNT
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
ST

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