510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081447Substantially Equivalent

Fourth Gas Module with CO2 for Primus US Apollo

Draeger Medical AG & Co. KG, Luebeck, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081447 is the FDA 510(k) clearance record for FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO, a class II device, cleared for Draeger Medical AG & Co. KG on under FDA product code BSZ (Gas-Machine, Anesthesia). FDA records list 10 510(k) clearances for Draeger Medical AG & Co. KG, from to . As of , FDA records show one recall naming K081447.

Clearance record

Decision date
Received
(139 days to decision)
Product code
BSZ Gas-Machine, Anesthesia
Regulation
21 CFR 868.5160
Device class
Class II
Review panel
Anesthesiology
Applicant
Draeger Medical AG & Co. KG 53/55 Moislinger Allee, Luebeck, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BSZ

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