Cleared Traditional

K880099 - VAN-TEC BLADDER EVACUATOR

K880099 is the FDA 510(k) clearance for VAN-TEC BLADDER EVACUATOR by Van-Tec, Inc.. It is a Class 2 Gastroenterology & Urology device (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.

View all Van-Tec, Inc. devices

Submission Details

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
80d faster than avg
Panel avg: 130d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.