Cleared Traditional

K903502 - LIFECOIL CATHETER

K903502 is an FDA 510(k) clearance for LIFECOIL CATHETER, manufactured by Lifemed of California. The device is a Class 2 Gastroenterology & Urology device with product code FJS cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K903502 · Lifemed of California · Gastroenterology & Urology device
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Oct 1990
Decision
80d
Days
Class 2
Risk

K903502 is an FDA 510(k) clearance for the LIFECOIL CATHETER. Classified as Catheter, Peritoneal, Long-term Indwelling (product code FJS), Class II - Special Controls.

Submitted by Lifemed of California (Compton, US). The FDA issued a Cleared decision on October 22, 1990 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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 Lifemed of California devices

FDA 510(k) Submission Details - K903502

510(k) Number K903502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1990
Decision Date October 22, 1990
Days to Decision 80 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
51d faster than avg
Panel avg: 131d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJS Device Classification - Class 2, Special Controls

Product Code FJS Catheter, Peritoneal, Long-term Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 - FJS Catheter, Peritoneal, Long-term Indwelling

All 30
Devices cleared under the same product code (FJS) and FDA review panel - the closest regulatory comparables to K903502.
FLEX-NECK PD CATHETER
K970159 · Janin Group, Inc. · Sep 1997
ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II
K961392 · Sil-Med Corp. · Jul 1997
MEDCOMP PERITONEAL DIALYSIS CATHETERS
K915490 · Medical Components, Inc. · Feb 1994
PERITONEAL CATHETERS
K902101 · Akcess Medical Products, Inc. · Jul 1990
PERITONEAL CATHETERS WITH AN ADDED FUNCTION
K890288 · Quinton, Inc. · Mar 1989
TRUDELL BENT CATHETER
K885167 · Sil-Med Corp. · Jan 1989