Product Code: LDE FDA class 1 21 CFR 870.1875

Stethoscope, Manual

Cardiovascular

A manual stethoscope is an acoustic medical instrument used by clinicians to auscultate heart sounds, lung sounds, and other body sounds for diagnostic assessment of cardiovascular and respiratory conditions. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls with no premarket notification needed. The product code is LDE, regulated under 21 CFR 870.1875, in the Cardiovascular specialty. No special risk flags apply.

View on FDA

510(k)s

FEI Numbers

180

Registration Numbers

180

Unique Applicants

Years Active

Research product code LDE in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: LDE
Device Class: FDA class 1
Regulation Number: 870.1875
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 28 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K945082	CYPRESS MEDICAL PRODUCTS STETHOSCOPE	Dec 08, 1994	Substantially Equivalent	Cypress Medical Products, Ltd.
K944337	VARIOUS STETHOSCOPES	Nov 30, 1994	Substantially Equivalent	Rud Riester GmbH & CO KG
K940578	MANUAL STETOSCOPE	Apr 26, 1994	Substantially Equivalent	Bhs Intl., Inc.
K935944	PROSCOPES AND ADSCOPES	Mar 03, 1994	Substantially Equivalent	American Diagnostic Corp.
K923327	STETHOSCOPE COVER	Nov 03, 1992	Substantially Equivalent	Anup Chakraborty Co.
K924095	TIMEOSCOPE AND FLEXISCOPE	Oct 20, 1992	Substantially Equivalent	Stethoscopes of America, Inc.
K914100	STETHOSCOPE	Nov 07, 1991	Substantially Equivalent	Atlas Medical Products, Inc.
K912128	MAXI-SCOPE OR ULTRA-SCOPE	Jun 28, 1991	Substantially Equivalent	Seiichi Mfg., Inc.
K905487	VARIOUS TYPES OF STETHOSCOPES	Apr 09, 1991	Substantially Equivalent	Liaoning-Usa Corp.
K904547	STETHOSCOPE	Mar 21, 1991	Substantially Equivalent	Kimball Industries Co., Ltd.
K895545	VSR(TM) SCOPE	Nov 15, 1989	Substantially Equivalent	Vsr Enterprises Corp.
K890126	KAMED STETHOSCOPE	Apr 21, 1989	Substantially Equivalent	D.R.G.
K882324	STETH-SHIELD ACCESSORY TO A STETHOSCOPE	Jul 18, 1988	Substantially Equivalent	Steth-Shield, Inc.
K871369	VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES:	Sep 24, 1987	Substantially Equivalent	Keeler Instruments, Inc.
K860473	DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPE	Aug 14, 1986	Substantially Equivalent	Schering Corp.
K854771	SALTZMAN STETHOSCOPE HEAD	May 09, 1986	Substantially Equivalent	K & S Medicorp
K843324	SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH	Jun 06, 1985	Substantially Equivalent	Cher Mel Corp.
K842203	LITTMAN TYPE SH-6010, NURSE TYPE	Jun 06, 1985	Substantially Equivalent	Cher Mel Corp.
K830796	THE BLOOM STETHOSCOPE	Jul 19, 1983	Substantially Equivalent	Stethophonics, Inc.
K821909	LITTMAN TUNABLE STETHOSCOPE 2136	Jul 14, 1982	Substantially Equivalent	3M Company
K813510	CARDIOSONIC ACOUSTIC AMPLIFIER	Jan 12, 1982	Substantially Equivalent	Srs Co.
K812676	AMPLITONE-3	Oct 13, 1981	Substantially Equivalent	Progressive Technology, Inc.
K801811	PALPATION ENHANCER	Sep 09, 1980	Substantially Equivalent	Medical Horizons Co.
K801215	ABCO PEDIATRIC STETHOSCOPE	Jun 04, 1980	Substantially Equivalent	Abco Dealers, Inc.
K801185	CONPHAR BOWLS STETHOSCOPE	Jun 04, 1980	Substantially Equivalent	Conphar, Inc.
K801184	CONPHAR SPRAGUE RAPPAPORT STETHOSCOPE	Jun 04, 1980	Substantially Equivalent	Conphar, Inc.
K801183	CONPHAR DUAL HEAD STETHOSCOPE	Jun 04, 1980	Substantially Equivalent	Conphar, Inc.
K780023	BLACK BAG, ELECTRONIC	Feb 21, 1978	Substantially Equivalent	Marshall Electronics, Inc.