510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K851509Substantially Equivalent

Ohmeda 7000 Electronic Anesthesia Ventilator

GE Healthcare, Madison WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851509 is the FDA 510(k) clearance record for OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR, a class II device, cleared for Ohmeda Medical on under FDA product code CBK (Ventilator, Continuous, Facility Use). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K851509.

Clearance record

Decision date
Received
(91 days to decision)
Product code
CBK Ventilator, Continuous, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Ohmeda Medical Ohmeda Dr., Madison WI
Third party review
No

Clearances, product code CBK

Trailing 12 months
4 clearances under product code CBK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CBK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260