510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003075Substantially Equivalent - Subject to Tracking Reg.

Knightstar 330 Ventilator

Mallinckrodt, Inc., St. Louis MO / Traditional, Substantially Equivalent - Subject to Tracking Reg.
FDA source (opens on fda.gov)

K003075 is the FDA 510(k) clearance record for KNIGHTSTAR 330 VENTILATOR, a class II device, cleared for Mallinckrodt, Inc. on under FDA product code MNT (Sv70 Ventilator). FDA records list 5 510(k) clearances for Mallinckrodt, Inc., from to . As of , FDA records show one recall naming K003075.

Clearance record

Decision date
Received
(434 days to decision)
Product code
MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Mallinckrodt, Inc. 675 Mcdonnell Blvd., St. Louis MO
Third party review
No

Clearances, product code MNT

Trailing 12 months
1 clearance under product code MNT in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MNT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260