Cleared Traditional

K871369 - VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES:

K871369 is an FDA 510(k) clearance for VARIOUS TYPES OF: KEELER MAGNATONE 2 ST..., manufactured by Keeler Instruments, Inc.. The device is a Class 1 Cardiovascular device with product code LDE cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K871369 · Keeler Instruments, Inc. · Cardiovascular device
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Sep 1987
Decision
170d
Days
Class 1
Risk

K871369 is an FDA 510(k) clearance for the VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES:. Classified as Stethoscope, Manual (product code LDE), Class I - General Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on September 24, 1987 after a review of 170 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K871369

510(k) Number K871369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1987
Decision Date September 24, 1987
Days to Decision 170 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 125d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

LDE Device Classification - Class 1, General Controls

Product Code LDE Stethoscope, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.1875
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 - LDE Stethoscope, Manual

All 23
Devices cleared under the same product code (LDE) and FDA review panel - the closest regulatory comparables to K871369.
V*S*R(TM) SCOPE
K895545 · Vsr Enterprises Corp. · Nov 1989
KAMED STETHOSCOPE
K890126 · D.R.G. · Apr 1989
STETH-SHIELD ACCESSORY TO A STETHOSCOPE
K882324 · Steth-Shield, Inc. · Jul 1988
DIFFERENTIAL STETHOSCOPE W/DUAL HEADS
K860473 · Schering Corp. · Aug 1986
SALTZMAN STETHOSCOPE HEAD
K854771 · K & S Medicorp · May 1986
THE BLOOM STETHOSCOPE
K830796 · Stethophonics, Inc. · Jul 1983
K871369 · VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES:
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