Cleared Traditional

K855140 - ANGIOMED RENAL DILATION SET

K855140 is an FDA 510(k) clearance for ANGIOMED RENAL DILATION SET, manufactured by Angiomed U.S., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K855140 · Angiomed U.S., Inc. · Gastroenterology & Urology device
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Feb 1986
Decision
60d
Days
Class 2
Risk

K855140 is an FDA 510(k) clearance for the ANGIOMED RENAL DILATION SET. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Angiomed U.S., Inc. (Anaheim, US). The FDA issued a Cleared decision on February 24, 1986 after a review of 60 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 Angiomed U.S., Inc. devices

FDA 510(k) Submission Details - K855140

510(k) Number K855140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date February 24, 1986
Days to Decision 60 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
71d faster than avg
Panel avg: 131d · This submission: 60d
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 154
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K855140.
ANGIOMED URETER DIATION SETS
K855076 · Angiomed U.S., Inc. · Mar 1986
ANGIOMED EXCHANGE DRAINAGE CATHETER SETS
K855143 · Angiomed U.S., Inc. · Mar 1986
CURITY & KENGUARD SILICONE COATED FOLEY CATHETER
K860484 · The Kendal Co. · Mar 1986
ANGIOMED HARZMANN DISCS
K855077 · Angiomed U.S., Inc. · Jan 1986
KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMP
K852084 · The Kendal Co. · Sep 1985
PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE
K853207 · American Pharmaseal Div. Ahsc · Sep 1985