Cleared Traditional

BARD-PARKER IRRIGATION CATHETER (K852099) - FDA 510(k) Clearance

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

K852099 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Cardiovascular device
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Aug 1985
Decision
86d
Days
Class 2
Risk

K852099 is an FDA 510(k) clearance for the BARD-PARKER IRRIGATION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 9, 1985 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K852099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1985
Decision Date August 09, 1985
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 312
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K852099.
REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE
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TRIPLE LUMEN RIGHT ATRIAL CATHETER
K852815 · Quinton, Inc. · Aug 1985
MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT
K852388 · Quinton, Inc. · Aug 1985
MULTIPRO CATHETER
K841797 · Shiley, Inc. · Aug 1984
RAAF DUAL LUMEN CATHETER
K842176 · Quinton, Inc. · Jul 1984
MAHURKAR DUAL LIMEN FEMORAL CATHETER
K834109 · Quinton, Inc. · Feb 1984