510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921297Substantially Equivalent

Drager Dve 4000 Series System

Alm Surgical Equipment, Inc., Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921297 is the FDA 510(k) clearance record for DRAGER DVE 4000 SERIES SYSTEM, a class I device, cleared for Alm Surgical Equipment, Inc. on under FDA product code FQO (Table, Operating-Room, Ac-Powered). FDA records list 10 510(k) clearances for Alm Surgical Equipment, Inc., from to . As of , FDA records show no recalls naming K921297.

Clearance record

Decision date
Received
(255 days to decision)
Product code
FQO Table, Operating-Room, Ac-Powered
Regulation
21 CFR 878.4960
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Alm Surgical Equipment, Inc. 3323 W. Warner Ave., Santa Ana CA
510(k) summary
Summary
Third party review
No

Clearances, product code FQO

Trailing 12 months

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

FDA records show no clearances under product code FQO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FQO, 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