510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042184Substantially Equivalent

Goodknight H20, Model M-114600-00

Mallinckrodt Developpement France, Villers-Les-Nancy Cedex, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042184 is the FDA 510(k) clearance record for GOODKNIGHT H20, MODEL M-114600-00, a class II device, cleared for Mallinckrodt Developpement France on under FDA product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)). FDA records list 7 510(k) clearances for Mallinckrodt Developpement France, from to . As of , FDA records show no recalls naming K042184.

Clearance record

Decision date
Received
(151 days to decision)
Product code
BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation
21 CFR 868.5450
Device class
Class II
Review panel
Anesthesiology
Applicant
Mallinckrodt Developpement France 10 Allee Pelletier Doisy, Villers-Les-Nancy Cedex, FR
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code BTT

Trailing 12 months
5 clearances under product code BTT in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BTT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260