Cleared Traditional

K802286 - ARGLE LATEX PENROSE TUBING

K802286 is the FDA 510(k) clearance for ARGLE LATEX PENROSE TUBING by Sherwood Medical Co.. It is a Class 1 General & Plastic Surgery device (product code KGZ) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K802286 · Sherwood Medical Co. · General & Plastic Surgery device
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Oct 1980
Decision
34d
Days
Class 1
Risk

K802286 is an FDA 510(k) clearance for the ARGLE LATEX PENROSE TUBING. Classified as Accessories, Catheter (product code KGZ), Class I - General Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 K802286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1980
Decision Date October 23, 1980
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGZ Accessories, Catheter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - KGZ Accessories, Catheter

All 10
Devices cleared under the same product code (KGZ) and FDA review panel - the closest regulatory comparables to K802286.
DESERET OFFSET PRN ADAPTER
K821245 · Warner-Lambert Co. · May 1982
PERI-PATCH GLUE MOLD
K810530 · Quinton, Inc. · Mar 1981
PERI-PATCH PERITONEAL CATHETER EXTENSION
K810531 · Quinton, Inc. · Mar 1981
ARROW CATHETER CLAMP
K802367 · Arrow Intl., Inc. · Oct 1980
CONPHAR CATHETER PLUG
K791803 · Conphar, Inc. · Sep 1979
CONPHAR ADAPT-CONNECTS STERILE, NONSTE.
K791806 · Conphar, Inc. · Sep 1979