Cleared Traditional

K904557 - MICROFLO

K904557 is an FDA 510(k) clearance for MICROFLO, manufactured by Life-Tech Intl., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EXY cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K904557 · Life-Tech Intl., Inc. · Gastroenterology & Urology device
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Dec 1990
Decision
84d
Days
Class 2
Risk

K904557 is an FDA 510(k) clearance for the MICROFLO. Classified as Uroflowmeter (product code EXY), Class II - Special Controls.

Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on December 28, 1990 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1800 - 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 - K904557

510(k) Number K904557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1990
Decision Date December 28, 1990
Days to Decision 84 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
47d faster than avg
Panel avg: 131d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EXY Device Classification - Class 2, Special Controls

Product Code EXY Uroflowmeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1800
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 - EXY Uroflowmeter

All 7
Devices cleared under the same product code (EXY) and FDA review panel - the closest regulatory comparables to K904557.
Uroflowmeter
K142425 · Be Technologies, Inc. · Oct 2014
GR100F URINE FLOWMETER
K971913 · Albyn Medical , Ltd. · Sep 1997
DANTEC DA CAPO
K953999 · Dantec Medical, Inc. · Nov 1995
HOME URODATA SYSTEM(TM)
K900770 · Biodan Medical Systems, Ltd. · Jun 1990
MODEL 1859 TUMI/PRESSURE MODULE
K873695 · Life-Tech Intl., Inc. · Jan 1988
MODEL 1858 CAVRO/PRESSURE MODULE
K872077 · Life-Tech Intl., Inc. · Aug 1987