510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K000186Substantially Equivalent

Datex-Ohmeda Inovent Delivery System

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

K000186 is the FDA 510(k) clearance record for DATEX-OHMEDA INOVENT DELIVERY SYSTEM, a class II device, cleared for Datex-Ohmeda on under FDA product code MRN (Apparatus, Nitric Oxide Delivery). FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show one recall naming K000186.

Clearance record

Decision date
Received
(27 days to decision)
Product code
MRN Apparatus, Nitric Oxide Delivery
Regulation
21 CFR 868.5165
Device class
Class II
Review panel
Anesthesiology
Applicant
Datex-Ohmeda P.O. Box 7550, Madison WI
510(k) summary
Summary
Third party review
No

Clearances, product code MRN

Trailing 12 months

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

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