Cleared Traditional

K142425 - Uroflowmeter

K142425 is an FDA 510(k) clearance for Uroflowmeter, manufactured by Be Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EXY cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K142425 · Be Technologies, Inc. · Gastroenterology & Urology device
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Oct 2014
Decision
59d
Days
Class 2
Risk

K142425 is an FDA 510(k) clearance for the Uroflowmeter. Classified as Uroflowmeter (product code EXY), Class II - Special Controls.

Submitted by Be Technologies, Inc. (San Francisco, US). The FDA issued a Cleared decision on October 27, 2014 after a review of 59 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 Be Technologies, Inc. devices

FDA 510(k) Submission Details - K142425

510(k) Number K142425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2014
Decision Date October 27, 2014
Days to Decision 59 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 131d · This submission: 59d
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 Consultant

Namsa
Angela Mallery

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EXY Uroflowmeter

All 7
Devices cleared under the same product code (EXY) and FDA review panel - the closest regulatory comparables to K142425.
GR100F URINE FLOWMETER
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MICROFLO
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HOME URODATA SYSTEM(TM)
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MODEL 1859 TUMI/PRESSURE MODULE
K873695 · Life-Tech Intl., Inc. · Jan 1988
MODEL 1858 CAVRO/PRESSURE MODULE
K872077 · Life-Tech Intl., Inc. · Aug 1987