Cleared Traditional

K951442 - FLOLAB

K951442 is an FDA 510(k) clearance for FLOLAB, manufactured by Synectics Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EXY cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K951442 · Synectics Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
148d
Days
Class 2
Risk

K951442 is an FDA 510(k) clearance for the FLOLAB. Classified as Uroflowmeter (product code EXY), Class II - Special Controls.

Submitted by Synectics Medical, Inc. (S-116 28 Stockholm, SE). The FDA issued a Cleared decision on August 24, 1995 after a review of 148 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Synectics Medical, Inc. devices

FDA 510(k) Submission Details - K951442

510(k) Number K951442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1995
Decision Date August 24, 1995
Days to Decision 148 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 131d · This submission: 148d
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 K951442.
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K872077 · Life-Tech Intl., Inc. · Aug 1987