Cleared Traditional

K830444 - STERILE

K830444 is the FDA 510(k) clearance for STERILE by Abco Dealers, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K830444 · Abco Dealers, Inc. · Gastroenterology & Urology device
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Mar 1983
Decision
27d
Days
Class 2
Risk

K830444 is an FDA 510(k) clearance for the STERILE, ALL PURPOSE URETHRAL CATHETER. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 27 days - a notably fast clearance 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: 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 Abco Dealers, Inc. devices

Submission Details

510(k) Number K830444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1983
Decision Date March 09, 1983
Days to Decision 27 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
103d faster than avg
Panel avg: 130d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 115
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K830444.
FOLEY-TEMP
K831567 · Mallinckrodt Critical Care · Aug 1983
IMPROVED SILICATH SILICONE ELASTOMER
K832165 · Travenol Laboratories, S.A. · Aug 1983
URETERAL STONE EXTRACTOR CATHETER
K831244 · American Edwards Laboratories · Jun 1983
CATHETER HOLDER
K823818 · Danek Medical, Inc. · Jan 1983
DYNACOR URETHRAL CATHETER TRAY
K821970 · Medline Industries, Inc. · Jul 1982
BARDEX ALL SILICONE PEDIATRIC CATHETER
K821745 · C.R. Bard, Inc. · Jun 1982