Cleared Traditional

K880099 - VAN-TEC BLADDER EVACUATOR

K880099 is an FDA 510(k) clearance for VAN-TEC BLADDER EVACUATOR, manufactured by Van-Tec, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KQT cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K880099 · Van-Tec, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
50d
Days
Class 2
Risk

K880099 is an FDA 510(k) clearance for the VAN-TEC BLADDER EVACUATOR. Classified as Evacuator, Gastro-urology (product code KQT), Class II - Special Controls.

Submitted by Van-Tec, Inc. (Spencer, US). The FDA issued a Cleared decision on March 2, 1988 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4370 - 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.

FDA 510(k) Submission Details - K880099

510(k) Number K880099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1988
Decision Date March 02, 1988
Days to Decision 50 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 131d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KQT Device Classification - Class 2, Special Controls

Product Code KQT Evacuator, Gastro-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4370
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 - KQT Evacuator, Gastro-urology

All 13
Devices cleared under the same product code (KQT) and FDA review panel - the closest regulatory comparables to K880099.
EVACUATOR, GASTRO-UROLOGY
K921088 · Northgate Technologies, Inc. · Oct 1992
EVACUATOR, GASTRO-UROLOGY
K921451 · Northgate Technologies, Inc. · Oct 1992
CLEANFLOW SYSTEM
K910728 · Mitron Technologies, Inc. · Apr 1991
BELLA - VAC IRRIGATOR
K874493 · Bel-Can Industries · Feb 1988
ELLIK EVACUATOR
K860266 · R. J. Ltd., Ind. · Mar 1986
DOSIMETRIC RELEASE
K830546 · American Hospital Supply Corp. · May 1983
K880099 · VAN-TEC BLADDER EVACUATOR
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