Cleared Traditional

K904547 - STETHOSCOPE

K904547 is an FDA 510(k) clearance for STETHOSCOPE, manufactured by Kimball Industries Co., Ltd.. The device is a Class 1 Cardiovascular device with product code LDE cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K904547 · Kimball Industries Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
169d
Days
Class 1
Risk

K904547 is an FDA 510(k) clearance for the STETHOSCOPE. Classified as Stethoscope, Manual (product code LDE), Class I - General Controls.

Submitted by Kimball Industries Co., Ltd. (Shirley, US). The FDA issued a Cleared decision on March 21, 1991 after a review of 169 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 Kimball Industries Co., Ltd. devices

FDA 510(k) Submission Details - K904547

510(k) Number K904547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1990
Decision Date March 21, 1991
Days to Decision 169 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 125d · This submission: 169d
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 8
Devices cleared under the same product code (LDE) and FDA review panel - the closest regulatory comparables to K904547.
CYPRESS MEDICAL PRODUCTS STETHOSCOPE
K945082 · Cypress Medical Products, Ltd. · Dec 1994
PROSCOPES AND ADSCOPES
K935944 · American Diagnostic Corp. · Mar 1994
VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES:
K871369 · Keeler Instruments, Inc. · Sep 1987
LITTMAN TUNABLE STETHOSCOPE 2136
K821909 · 3M Company · Jul 1982
CONPHAR DUAL HEAD STETHOSCOPE
K801183 · Conphar, Inc. · Jun 1980
CONPHAR SPRAGUE RAPPAPORT STETHOSCOPE
K801184 · Conphar, Inc. · Jun 1980