Cleared Traditional

K914891 - PULLER OPTION FOR ETUDE(TM)

K914891 is an FDA 510(k) clearance for PULLER OPTION FOR ETUDE(TM), 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 68-day FDA review.

K914891 · Dantec Medical, Inc. · Gastroenterology & Urology device
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Jan 1992
Decision
68d
Days
Class 2
Risk

K914891 is an FDA 510(k) clearance for the PULLER OPTION FOR ETUDE(TM). 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 7, 1992 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dantec Medical, Inc. devices

FDA 510(k) Submission Details - K914891

510(k) Number K914891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1991
Decision Date January 07, 1992
Days to Decision 68 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
62d faster than avg
Panel avg: 130d · This submission: 68d
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 K914891.
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