Cleared Traditional

K875383 - LAKE CATHETER CARE KITS (MODIFICATION)

K875383 is the FDA 510(k) clearance for LAKE CATHETER CARE KITS (MODIFICATION) by Lake Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K875383 · Lake Medical Products, Inc. · Gastroenterology & Urology device
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Mar 1988
Decision
85d
Days
Class 2
Risk

K875383 is an FDA 510(k) clearance for the LAKE CATHETER CARE KITS (MODIFICATION). Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Lake Medical Products, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 9, 1988 after a review of 85 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 Lake Medical Products, Inc. devices

Submission Details

510(k) Number K875383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received December 15, 1987
Decision Date March 09, 1988
Days to Decision 85 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
45d faster than avg
Panel avg: 130d · This submission: 85d
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 70
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K875383.
CATHETERS, MALE, FEMALE
K892691 · Zinnanti Surgical Instruments, Inc. · Jun 1989
CATHETER STRAP
K881781 · Baxter Healthcare Corp · Aug 1988
COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING
K880100 · Cook Urological, Inc. · Mar 1988
COOK-VPI INTERMITTENT CATHETER
K863082 · Cook Urological, Inc. · Nov 1986
BIO-GUARD AB COATED CATHETER
K863354 · Cook Urological, Inc. · Nov 1986
TROCAR/CANNULA/SHEATH SET
K853337 · American Edwards Laboratories · Aug 1985