Cleared Traditional

K913169 - DANTEC UD 5500 MK2

K913169 is an FDA 510(k) clearance for DANTEC UD 5500 MK2, manufactured by Dantec Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K913169 · Dantec Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
190d
Days
Class 2
Risk

K913169 is an FDA 510(k) clearance for the DANTEC UD 5500 MK2. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Dantec Medical, Inc. (Washington, US). The FDA issued a Cleared decision on January 23, 1992 after a review of 190 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 Dantec Medical, Inc. devices

FDA 510(k) Submission Details - K913169

510(k) Number K913169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1991
Decision Date January 23, 1992
Days to Decision 190 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
60d slower than avg
Panel avg: 130d · This submission: 190d
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 K913169.
URETHRALPRESSURE PROFILE CATHETER
K915484 · Life-Tech Intl., Inc. · Feb 1992
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