Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

LDE — Predicate Candidate Screening

28 FDA 510(k) clearances under this product code; the 50 most recent screened below.

68 daysmedian FDA review time

189 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days
K945082	CYPRESS MEDICAL PRODUCTS STETHOSCOPE	Cypress Medical Products, Ltd.	1994-12-08	52
K944337	VARIOUS STETHOSCOPES	Rud Riester GmbH & CO KG	1994-11-30	85
K940578	MANUAL STETOSCOPE	Bhs Intl., Inc.	1994-04-26	77
K935944	PROSCOPES AND ADSCOPES	American Diagnostic Corp.	1994-03-03	80
K923327	STETHOSCOPE COVER	Anup Chakraborty Co.	1992-11-03	119
K924095	TIMEOSCOPE AND FLEXISCOPE	Stethoscopes of America, Inc.	1992-10-20	68
K914100	STETHOSCOPE	Atlas Medical Products, Inc.	1991-11-07	56
K912128	MAXI-SCOPE OR ULTRA-SCOPE	Seiichi Mfg., Inc.	1991-06-28	45
K905487	VARIOUS TYPES OF STETHOSCOPES	Liaoning-Usa Corp.	1991-04-09	124
K904547	STETHOSCOPE	Kimball Industries Co., Ltd.	1991-03-21	169
K895545	VSR(TM) SCOPE	Vsr Enterprises Corp.	1989-11-15	63
K890126	KAMED STETHOSCOPE	D.R.G.	1989-04-21	99
K882324	STETH-SHIELD ACCESSORY TO A STETHOSCOPE	Steth-Shield, Inc.	1988-07-18	42
K871369	VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES:	Keeler Instruments, Inc.	1987-09-24	170
K860473	DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPE	Schering Corp.	1986-08-14	189
K854771	SALTZMAN STETHOSCOPE HEAD	K & S Medicorp	1986-05-09	161
K842203	LITTMAN TYPE SH-6010, NURSE TYPE	Cher Mel Corp.	1985-06-06	367
K843324	SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH	Cher Mel Corp.	1985-06-06	286
K830796	THE BLOOM STETHOSCOPE	Stethophonics, Inc.	1983-07-19	127
K821909	LITTMAN TUNABLE STETHOSCOPE 2136	3M Company	1982-07-14	16
K813510	CARDIOSONIC ACOUSTIC AMPLIFIER	Srs Co.	1982-01-12	28
K812676	AMPLITONE-3	Progressive Technology, Inc.	1981-10-13	21
K801811	PALPATION ENHANCER	Medical Horizons Co.	1980-09-09	63
K801184	CONPHAR SPRAGUE RAPPAPORT STETHOSCOPE	Conphar, Inc.	1980-06-04	19
K801185	CONPHAR BOWLS STETHOSCOPE	Conphar, Inc.	1980-06-04	16
K801215	ABCO PEDIATRIC STETHOSCOPE	Abco Dealers, Inc.	1980-06-04	15
K801183	CONPHAR DUAL HEAD STETHOSCOPE	Conphar, Inc.	1980-06-04	19
K780023	BLACK BAG, ELECTRONIC	Marshall Electronics, Inc.	1978-02-21	48

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda