510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K021265Substantially Equivalent

Datex-Ohmeda Hmef 500

GE Healthcare, Needham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021265 is the FDA 510(k) clearance record for DATEX-OHMEDA HMEF 500, a class II device, cleared for Datex-Ohmeda on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K021265.

Clearance record

Decision date
Received
(130 days to decision)
Product code
CAH Filter, Bacterial, Breathing-Circuit
Regulation
21 CFR 868.5260
Device class
Class II
Review panel
Anesthesiology
Applicant
Datex-Ohmeda 86 Pilgrim Rd., Needham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CAH

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