Cleared Traditional

K850422 - ATS ACOUSTIC STANDOFF - WATER BAG

K850422 is an FDA 510(k) clearance for ATS ACOUSTIC STANDOFF - WATER BAG, manufactured by Ats Laboratories, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K850422 · Ats Laboratories, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
51d
Days
Class 2
Risk

K850422 is an FDA 510(k) clearance for the ATS ACOUSTIC STANDOFF - WATER BAG. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Ats Laboratories, Inc. (Bridgeport, US). The FDA issued a Cleared decision on March 27, 1985 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ats Laboratories, Inc. devices

FDA 510(k) Submission Details - K850422

510(k) Number K850422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1985
Decision Date March 27, 1985
Days to Decision 51 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 107d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 354
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K850422.
CONVEX PROBE, PVE-393M
K851526 · Toshiba Medical Systems · Sep 1985
SONOLAYER-V, SSA-90A
K851036 · Toshiba Medical Systems · Sep 1985
MODEL 21225A CW COPPLER/IMAGING TRANSDUCER
K852132 · Hewlett-Packard Co. · Aug 1985
CIVCO-SUPER SCAN/BIOPSY GUIDE
K843573 · CIVCO Medical Instruments Co., Inc. · Dec 1984
3.5 MHZ BIOPSY TRANSDUCER
K812929 · General Electric Co. · Nov 1981
BIOPSY TRANSDUCER
K811843 · Siemens Gammasonics, Inc. · Aug 1981