Cleared Traditional

CAVROPUMP (K871129) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K871129 · Life-Tech Intl., Inc. · Gastroenterology & Urology device
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Aug 1987
Decision
161d
Days
Class 2
Risk

K871129 is an FDA 510(k) clearance for the CAVROPUMP. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on August 28, 1987 after a review of 161 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 870.1650 - 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 Life-Tech Intl., Inc. devices

Submission Details

510(k) Number K871129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1987
Decision Date August 28, 1987
Days to Decision 161 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
31d slower than avg
Panel avg: 130d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 49
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K871129.
USCI PRESTO DISPOSABLE INFLATION DEVICE
K896415 · C.R. Bard, Inc. · Jan 1990
MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
K884913 · Merit Medical Systems, Inc. · Apr 1989
DISPOSABLE CORONARY CONTROL SYRINGE 12CC
K875196 · Merit Medical Systems, Inc. · Feb 1988
CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY
K863537 · Cordis Corp. · Oct 1986
USCI (R) DISPOSABLE INFLATION DEVICE
K863037 · C.R. Bard, Inc. · Sep 1986
ANGIOPLASTY INFLATION DEVICE & CARTR
K834107 · Cordis Corp. · Jan 1984