510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K993584Substantially Equivalent

Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2

Nellcor Puritan Bennett France Dvpt., Villers-Les-Nancy Cedex, FR / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K993584 is the FDA 510(k) clearance record for MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2, a class II device, cleared for Nellcor Puritan Bennett France Dvpt. on under FDA product code BZD (Ventilator, Non-Continuous (Respirator)). FDA records list 2 510(k) clearances for Nellcor Puritan Bennett France Dvpt., from to . As of , FDA records show no recalls naming K993584.

Clearance record

Decision date
Received
(137 days to decision)
Product code
BZD Ventilator, Non-Continuous (Respirator)
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Nellcor Puritan Bennett France Dvpt. 10 Allee Pelletier Doisy, Villers-Les-Nancy Cedex, FR
510(k) summary
Summary
Third party review
No

Clearances, product code BZD

Trailing 12 months
11 clearances under product code BZD in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZD, trailing twelve months
MonthClearances
November 20250
December 20252
January 20262
February 20260
March 20260
April 20262
May 20262
June 20261
July 20261
August 20260
September 20261
October 20260