Cleared Traditional

K913736 - DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST

K913736 is an FDA 510(k) clearance for DOBBHOFF ANORECT BIOFEED SYST FIVE DIV ..., manufactured by Biosearch Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K913736 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
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Feb 1992
Decision
171d
Days
Class 2
Risk

K913736 is an FDA 510(k) clearance for the DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on February 7, 1992 after a review of 171 days - an extended review cycle.

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.

View all Biosearch Medical Products, Inc. devices

FDA 510(k) Submission Details - K913736

510(k) Number K913736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1991
Decision Date February 07, 1992
Days to Decision 171 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 131d · This submission: 171d
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 39
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K913736.
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URETHRALPRESSURE PROFILE CATHETER
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URODYNAMIC CATHETER
K915443 · Cook Urological, Inc. · Feb 1992
DANTEC UD 5500 MK2
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PULLER OPTION FOR ETUDE(TM)
K914891 · Dantec Medical, Inc. · Jan 1992
DANTEC MENUET
K912701 · Dantec Medical, Inc. · Dec 1991