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
K223818Substantially Equivalent

Model 9160 VitaloQUB

Vitalograph Ireland Ltd., Ennis Co Clare, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223818 is the FDA 510(k) clearance record for Model 9160 VitaloQUB, a class II device, cleared for Vitalograph Ireland, Ltd. on under FDA product code JEH (Plethysmograph, Volume). FDA records list 12 510(k) clearances for Vitalograph Ireland, Ltd., from to . As of , FDA records show no recalls naming K223818.

Clearance record

Decision date
Received
(155 days to decision)
Product code
JEH Plethysmograph, Volume
Regulation
21 CFR 868.1760
Device class
Class II
Review panel
Anesthesiology
Applicant
Vitalograph Ireland, Ltd. Gort Rd. Business Park, Ennis Co Clare, IE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JEH

Trailing 12 months

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

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