Cleared Traditional

K810533 - CIRCLE NEPHROSTOMY TUBE INTRODUCER

K810533 is the FDA 510(k) clearance for CIRCLE NEPHROSTOMY TUBE INTRODUCER by American V. Mueller. It is a Class 1 Gastroenterology & Urology device (product code KOA) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K810533 · American V. Mueller · Gastroenterology & Urology device

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Mar 1981

Decision

13d

Days

Class 1

Risk

K810533 is an FDA 510(k) clearance for the CIRCLE NEPHROSTOMY TUBE INTRODUCER. Classified as Surgical Instruments, G-u, Manual (and Accessories) (product code KOA), Class I - General Controls.

Submitted by American V. Mueller (Mchenry, US). The FDA issued a Cleared decision on March 11, 1981 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - 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 American V. Mueller devices

Submission Details

510(k) Number	K810533 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 26, 1981
Decision Date	March 11, 1981
Days to Decision	13 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

117d faster than avg

Panel avg: 130d · This submission: 13d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	KOA Surgical Instruments, G-u, Manual (and Accessories)
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 876.4730

What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KOA Surgical Instruments, G-u, Manual (and Accessories)

All 22

Devices cleared under the same product code (KOA) and FDA review panel - the closest regulatory comparables to K810533.

PROBES, VARIOUS

K841003 · Premier Dental Products Co. · Mar 1984

P-S MEDICAL BERLIN VISADUCT KIT

K832677 · Pudenz-Schulte Medical Research Corp. · Dec 1983

VASOVASOSTOMY STABILIZER PLATFORM DEV

K811223 · Biomet, Inc. · May 1981

FLEXIBLE CUTTING SCISSORS

K760715 · V. Mueller O.V. Baxter Healthcare Corp. · Oct 1976

FLEXIBLE BIOPSY FORCEPS

K760717 · V. Mueller O.V. Baxter Healthcare Corp. · Oct 1976

FLEXIBLE FOREIGN BODY FORCEPS

K760716 · V. Mueller O.V. Baxter Healthcare Corp. · Oct 1976

Related FDA 510(k) Regulatory Insights

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

Manufacturer of K810533

American V. Mueller

Mchenry, IL · US

Regulatory profile

31 submissions 29 cleared

94% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

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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 . Updated monthly.

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