Cleared Traditional

K904646 - BCI-100 FECAL INCONTINENCE SYSTEM

K904646 is an FDA 510(k) clearance for BCI-100 FECAL INCONTINENCE SYSTEM, manufactured by Biocare Intl.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K904646 · Biocare Intl. · Gastroenterology & Urology device
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Mar 1991
Decision
159d
Days
Class 2
Risk

K904646 is an FDA 510(k) clearance for the BCI-100 FECAL INCONTINENCE SYSTEM. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Biocare Intl. (Wantagh, US). The FDA issued a Cleared decision on March 19, 1991 after a review of 159 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 Biocare Intl. devices

FDA 510(k) Submission Details - K904646

510(k) Number K904646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1990
Decision Date March 19, 1991
Days to Decision 159 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
29d slower than avg
Panel avg: 130d · This submission: 159d
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 25
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K904646.
URODYNAMIC CATHETER
K915443 · Cook Urological, Inc. · Feb 1992
DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST
K913736 · Biosearch Medical Products, Inc. · Feb 1992
URODYNAMIC RECTAL BALLOON
K912451 · Cook Urological, Inc. · Dec 1991
UROLAB JANUS
K904386 · Life-Tech Intl., Inc. · Nov 1990
BIOSEARCH ANAL BIOFEEDBACK DEVICE
K902843 · Biosearch Medical Products, Inc. · Sep 1990
SURGITEK CO2 DELIVERY SYSTEM
K881736 · Medical Engineering Corp. · Aug 1988