Cleared Traditional

K853207 - PHARM 100% SILICONE FOLEY CATH TEMPERAT...

K853207 is an FDA 510(k) clearance for PHARM 100% SILICONE FOLEY CATH TEMPERAT..., manufactured by American Pharmaseal Div. Ahsc. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K853207 · American Pharmaseal Div. Ahsc · Gastroenterology & Urology device
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Sep 1985
Decision
43d
Days
Class 2
Risk

K853207 is an FDA 510(k) clearance for the PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by American Pharmaseal Div. Ahsc (Valencia, US). The FDA issued a Cleared decision on September 12, 1985 after a review of 43 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 American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K853207

510(k) Number K853207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1985
Decision Date September 12, 1985
Days to Decision 43 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
87d faster than avg
Panel avg: 130d · This submission: 43d
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 136
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K853207.
ANGIOMED RENAL DILATION SET
K855140 · Angiomed U.S., Inc. · Feb 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
TROCAR/CANNULA/SHEATH SET
K853337 · American Edwards Laboratories · Aug 1985
VAN-TEC GUIDE WIRE W/HYDROMER COATING
K851160 · Van-Tec, Inc. · Jul 1985
UROLOGICAL CATHETER & ACCESSORIES FOLEY CATHETER
K851857 · Sheridan Catheter Corp. · Jul 1985