Cleared Traditional

K871369 - VARIOUS TYPES OF: KEELER MAGNATONE 2 ST...

K871369 is the FDA 510(k) clearance for VARIOUS TYPES OF: KEELER MAGNATONE 2 ST... by Keeler Instruments, Inc.. It is a Class 1 Cardiovascular device (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.

View all Keeler Instruments, Inc. devices

Submission Details

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.

Device Classification

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

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