Cleared Traditional

K820872 - CURITY SHETHOSCOPE SECURING PADS

K820872 is an FDA 510(k) clearance for CURITY SHETHOSCOPE SECURING PADS, manufactured by The Kendal Co.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K820872 · The Kendal Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1982
Decision
16d
Days
Class 1
Risk

K820872 is an FDA 510(k) clearance for the CURITY SHETHOSCOPE SECURING PADS. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by The Kendal Co. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1982 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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 The Kendal Co. devices

FDA 510(k) Submission Details - K820872

510(k) Number K820872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1982
Decision Date April 14, 1982
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - KGX Tape And Bandage, Adhesive

All 83
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K820872.
BREATHABLE OVERWRAY BANDAGE NON-ELAS
K833731 · American Medical Disposable, Inc. · Jan 1984
ONE TIME COMPOUND BENZOIN TINCTURE-
K833120 · Acme United Corp. · Dec 1983
3M STERI-STRIP ANTIMICROBIAL SKIN CLOS
K813265 · 3M Company · Feb 1983
NON-ADHER PADS
K813421 · Abco Dealers, Inc. · Dec 1981
ETHICON* SKIN CLOSURE TAPE
K813124 · Ethicon, Inc. · Dec 1981
DESERET CATHETER DRESSING
K812073 · Warner-Lambert Co. · Oct 1981