Cleared Traditional

K801787 - URINARY CATHETER CARE TRAYS #3700&3710 (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K801787 · The Healthcare Group Laboratories, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1980
Decision
85d
Days
Class 2
Risk

K801787 is an FDA 510(k) clearance for the URINARY CATHETER CARE TRAYS #3700&3710. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by The Healthcare Group Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 21, 1980 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 The Healthcare Group Laboratories, Inc. devices

Submission Details

510(k) Number K801787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1980
Decision Date October 21, 1980
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 237
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K801787.
Rubber Utility Catheter
K251864 · C.R. Bard, Inc. · Feb 2026
Wellead Ureteral Catheter
K220036 · Well Lead Medical Co., Ltd. · Dec 2022
allFlex Ureteral Catheters, Krait Ureteral Catheters
K220730 · Allwin Medical Devices, Inc. · Oct 2022
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
K211032 · Urogen Pharma, Ltd. · Nov 2021