Cleared Traditional

K823382 - NEPHROSTOMY CATHETER

K823382 · Umi, Inc. · Gastroenterology & Urology device

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Jan 1983

Decision

77d

Days

Risk

K823382 is an FDA 510(k) clearance for the NEPHROSTOMY CATHETER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Umi, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1983 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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 Umi, Inc. devices

FDA 510(k) Submission Details - K823382

510(k) Number	K823382 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 12, 1982
Decision Date	January 28, 1983
Days to Decision	77 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

54d faster than avg

Panel avg: 131d · This submission: 77d

Pathway characteristics

Predicate-based equivalence.

LJE Device Classification - Class 0,

Product Code	LJE Catheter, Nephrostomy
Device Class	-

Regulatory Peers - LJE Catheter, Nephrostomy

All 54

Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K823382.

PERCUTANEOUS NEPHROSTOMY CATHETER

K833008 · Medical Engineering Corp. · Oct 1983

URINARY DIVERSION STENT

K830803 · Van-Tec, Inc. · May 1983

SURGITEK PERCUTANEOUS NEPHROSTOMY CATH

K830226 · Medical Engineering Corp. · Feb 1983

HEYER-SCHUTE UNIVERSAL URETERAL STENT

K823418 · American Hospital Supply Corp. · Dec 1982

SURGITEK PERCUTANEOUS NEPHROST. STENT

K821776 · Medical Engineering Corp. · Aug 1982

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K823382

Umi, Inc.

Mchenry, IL · US

Regulatory profile

4 submissions 4 cleared

100% clearance rate · Active in Gastroenterology & Urology

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: January 28, 1983. Record added to 510k Database: March 2026.

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