510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K070421Substantially Equivalent

Datex-Ohmeda S/5 Device Interfacing Solution, N-Disxxxx..01 with N-Disvent..02

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

K070421 is the FDA 510(k) clearance record for DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02, a class II device, cleared for GE Healthcare on under FDA product code MSX (System, Network And Communication, Physiological Monitors). FDA records list 888 510(k) clearances for GE Healthcare, from to . As of , FDA records show one recall naming K070421.

Clearance record

Decision date
Received
(28 days to decision)
Product code
MSX System, Network And Communication, Physiological Monitors
Regulation
21 CFR 870.2300
Device class
Class II
Review panel
Cardiovascular
Applicant
GE Healthcare 86 Pilgrim Rd., Needham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSX

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