Cleared Traditional

K903495 - LIQUID DETECTOR

K903495 is an FDA 510(k) clearance for LIQUID DETECTOR, manufactured by Life-Tech Intl., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code DXT cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K903495 · Life-Tech Intl., Inc. · Gastroenterology & Urology device
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Oct 1990
Decision
63d
Days
Class 2
Risk

K903495 is an FDA 510(k) clearance for the LIQUID DETECTOR. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on October 5, 1990 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.1650 - the FDA gastroenterology and urology device 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 Life-Tech Intl., Inc. devices

FDA 510(k) Submission Details - K903495

510(k) Number K903495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1990
Decision Date October 05, 1990
Days to Decision 63 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 131d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 174
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K903495.
CLOSED SYSTEM FLUSH SET
K904994 · Argon Medical Corp. · Jan 1991
HIGH-PRESSURE CONNECTOR TUBE
K904212 · Mallinckrodt Medical · Dec 1990
MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMP
K903494 · Life-Tech Intl., Inc. · Oct 1990
MEDRAD MARK V-PLUS INJECTOR
K903390 · Medrad, Inc. · Sep 1990
MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE
K902221 · Mallinckrodt Group, Inc. · Aug 1990
B-D ANGIOGRAPHIC CONTROL SYRINGE
K895318 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1990