Cleared Traditional

K862098 - PRISTINE/BLOOMING/PRISTINE BLOOMING CUL...

K862098 is an FDA 510(k) clearance for PRISTINE/BLOOMING/PRISTINE BLOOMING CUL..., manufactured by Hall/Mccollum Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K862098 · Hall/Mccollum Laboratories, Inc. · Gastroenterology & Urology device
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Nov 1986
Decision
163d
Days
Class 2
Risk

K862098 is an FDA 510(k) clearance for the PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Hall/Mccollum Laboratories, Inc. (Charlottesville, US). The FDA issued a Cleared decision on November 12, 1986 after a review of 163 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Hall/Mccollum Laboratories, Inc. devices

FDA 510(k) Submission Details - K862098

510(k) Number K862098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1986
Decision Date November 12, 1986
Days to Decision 163 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
33d slower than avg
Panel avg: 130d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KOD Catheter, Urological

All 130
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K862098.
PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE
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VAN-TEC PUMPING SYSTEM
K870557 · Van-Tec, Inc. · Mar 1987
VAN-TEC OPEN ENDED CONE TIP URETERAL CATHETER
K870694 · Van-Tec, Inc. · Mar 1987
COOK-VPI INTERMITTENT CATHETER
K863082 · Cook Urological, Inc. · Nov 1986
BIO-GUARD AB COATED CATHETER
K863354 · Cook Urological, Inc. · Nov 1986
FOLEY CATHETERS
K863517 · Instrumentation Industries, Inc. · Oct 1986