Cleared Traditional

K871429 - ANTIMICROBIAL FOLEY CATHETER

K871429 is an FDA 510(k) clearance for ANTIMICROBIAL FOLEY CATHETER, 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 123-day FDA review.

K871429 · American Pharmaseal Div. Ahsc · Gastroenterology & Urology device
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Aug 1987
Decision
123d
Days
Class 2
Risk

K871429 is an FDA 510(k) clearance for the ANTIMICROBIAL FOLEY CATHETER. 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 August 10, 1987 after a review of 123 days - within the typical 510(k) review window.

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 American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K871429

510(k) Number K871429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1987
Decision Date August 10, 1987
Days to Decision 123 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
7d faster than avg
Panel avg: 130d · This submission: 123d
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 K871429.
ACKRAD RETROGRADE URETHROGRAPHY SET
K874312 · Ackrad Laboratories · Dec 1987
FOLEY CATHETER TEMPERATURE SENSOR
K873448 · Respiratory Support Products, Inc. · Dec 1987
PHARMASEAL RUBBER URETHRAL CATHETER
K874517 · American Pharmaseal Div. Ahsc · Dec 1987
KADIR HI-TORQUE GUIDE WIRE
K871297 · Argon Medical Corp. · Apr 1987
PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE
K870977 · American Pharmaseal Div. Ahsc · Apr 1987
VAN-TEC PUMPING SYSTEM
K870557 · Van-Tec, Inc. · Mar 1987