Cleared Traditional

K810216 - ARGYLE ROB-NELS

K810216 is the FDA 510(k) clearance for ARGYLE ROB-NELS by Sherwood Medical Co.. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K810216 · Sherwood Medical Co. · Gastroenterology & Urology device

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Feb 1981

Decision

13d

Days

Class 2

Risk

K810216 is an FDA 510(k) clearance for the ARGYLE ROB-NELS. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on February 9, 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 876.5130 - 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 Sherwood Medical Co. devices

Submission Details

510(k) Number	K810216 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 27, 1981
Decision Date	February 09, 1981
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

117d faster than avg

Panel avg: 130d · This submission: 13d

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 115

Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K810216.

PRE-FILLED SYRINGE & CYSTOFLO URINARY BG

K811924 · Travenol Laboratories, S.A. · Nov 1981

CURITY 100% SILICONE SAFETY INDICATOR

K810690 · The Kendal Co. · Apr 1981

SILICONE ELASTOMER COATED LATEX FOLEY

K810630 · G.D. Searle and Co. · Mar 1981

CLOSED SYSTEM URETHRAL CATHETERIZ. SET

K803259 · Medical Devices, Inc. · Jan 1981

FOLEY CATHETER

K803079 · American Hospital Supply Corp. · Dec 1980

ALL PUPOSE URETHRAL CATHETER

K803080 · American Hospital Supply Corp. · Dec 1980

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 K810216

Sherwood Medical Co.

Mchenry, IL · US

Regulatory profile

191 submissions 177 cleared

93% 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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