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
K850422Substantially Equivalent

Ats Acoustic Standoff - Water Bag

Ats Laboratories, Inc., Bridgeport CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850422 is the FDA 510(k) clearance record for ATS ACOUSTIC STANDOFF - WATER BAG, a class II device, cleared for Ats Laboratories, Inc. on under FDA product code ITX (Transducer, Ultrasonic, Diagnostic). FDA records list one 510(k) clearance for Ats Laboratories, Inc. As of , FDA records show no recalls naming K850422.

Clearance record

Decision date
Received
(51 days to decision)
Product code
ITX Transducer, Ultrasonic, Diagnostic
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Ats Laboratories, Inc. 404 Knowlton St., Bridgeport CT
Third party review
No

Clearances, product code ITX

Trailing 12 months
6 clearances under product code ITX in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code ITX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20263
August 20262
September 20261
October 20260