Cleared Traditional

K910444 - BROWNE MEDICAL SYSTEMS IMAGEPRO

K910444 is an FDA 510(k) clearance for BROWNE MEDICAL SYSTEMS IMAGEPRO, manufactured by Browne Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K910444 · Browne Medical Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
131d
Days
Class 2
Risk

K910444 is an FDA 510(k) clearance for the BROWNE MEDICAL SYSTEMS IMAGEPRO. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Browne Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 10, 1991 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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.

FDA 510(k) Submission Details - K910444

510(k) Number K910444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1991
Decision Date June 10, 1991
Days to Decision 131 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 131d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAP Device Classification - Class 2, Special Controls

Product Code FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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 - FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device

All 44
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K910444.
DANTEC MENUET
K912701 · Dantec Medical, Inc. · Dec 1991
URODYNAMIC RECTAL BALLOON
K912451 · Cook Urological, Inc. · Dec 1991
ETUDE (MODEL NUMBERS 24A05 & 24A06)
K913323 · Dantec Medical, Inc. · Sep 1991
UROLAB JANUS
K904386 · Life-Tech Intl., Inc. · Nov 1990
ETUDE, URODYNAMIC INVESTIGATION SYSTEM
K901494 · Dantec Medical, Inc. · Oct 1990
BIOSEARCH ANAL BIOFEEDBACK DEVICE
K902843 · Biosearch Medical Products, Inc. · Sep 1990