Cleared Traditional

K940578 - MANUAL STETOSCOPE

K940578 is an FDA 510(k) clearance for MANUAL STETOSCOPE, manufactured by Bhs Intl., Inc.. The device is a Class 1 Cardiovascular device with product code LDE cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K940578 · Bhs Intl., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
77d
Days
Class 1
Risk

K940578 is an FDA 510(k) clearance for the MANUAL STETOSCOPE. Classified as Stethoscope, Manual (product code LDE), Class I - General Controls.

Submitted by Bhs Intl., Inc. (Crofton, US). The FDA issued a Cleared decision on April 26, 1994 after a review of 77 days - a notably fast clearance 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: 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 Bhs Intl., Inc. devices

FDA 510(k) Submission Details - K940578

510(k) Number K940578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1994
Decision Date April 26, 1994
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
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 K940578.
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