510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790334Substantially Equivalent

Drager Orm

Draeger, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790334 is the FDA 510(k) clearance record for DRAGER ORM, a class I device, cleared for Draeger Medical, Inc. on under FDA product code BYR (Transducer, Gas Pressure, Differential). FDA records list 84 510(k) clearances for DRAEGER, INC., from to . As of , FDA records show no recalls naming K790334.

Clearance record

Decision date
Received
(19 days to decision)
Product code
BYR Transducer, Gas Pressure, Differential
Regulation
21 CFR 868.2875
Device class
Class I
Review panel
Anesthesiology
Applicant
Draeger Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BYR

Trailing 12 months

FDA records hold no clearances under product code BYR in the trailing twelve months.

FDA records show no clearances under product code BYR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BYR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260