510(k) · Cleared

Cleared

HL 200 Electronic Stethoscope

K050169510(k) TraditionalCleared Apr 5, 200569-day reviewClass II21 CFR 870.1875

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Health & Life Co., Ltd. · DQD Stethoscope, Electronic

Cleared on Apr 5, 2005 as substantially equivalent to K961848 (Minnesota Mining and Mfg. Co., 1997) after a 69-day review. Its family tree reaches back 2 generations to 1977.

Decided: Apr 5, 2005
Review: 69 days
Class: Class II
Product code: DQD
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K771653 (1977). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK771653 Electronic Stethoscope3M Company · 1977
1 generation backK961848 3M Littmann Electronic StethoscopeMinnesota Mining and Mfg. Co. · 1997
This deviceK050169 HL 200 Electronic StethoscopeHealth & Life Co., Ltd. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K771653	Electronic Stethoscope	3M Company	1977	—
−1	K961848	3M Littmann Electronic Stethoscope	Minnesota Mining and Mfg. Co.	1997	—
0 (this device)	K050169	HL 200 Electronic Stethoscope	Health & Life Co., Ltd.	2005	—

FIG. 1 — Lineage of K050169, 1977–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQD device

#1 K200776 Eko COREscore 25.2 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K961848	3M Littmann Electronic Stethoscope Summary page 1 …Classification name: Stethoscope, Electronic 3.0 Classification: Class II 4.0 Predicate Device: * 3M Littmann Model 2000 Electronic Stethoscope (K961848) marketed by 3M Health care. 5.0 Device Description: HL 200 ELECTRONIC STETHOSCOPE is a n…	Minnesota Mining and Mfg. Co.	1997	—

Also cleared against K961848: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 20.0 years on median.
None of the 2 ancestors has a recall.
4 other devices also cite its predicate K961848.

How does its category compare?

All DQD devices

DQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQD

3in 2025

2007high 10 (2023) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQD

89in 2025

2007high 262 (2019) · low 70 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQD

No recall names DQD since 2007.

Adverse event reports per year · DQD

1in 2024

2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code DQD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	2	—	0
2008	1	—	0
2009	6	161	0
2010	1	—	0
2011	4	107	1
2012	2	—	0
2013	5	70	1
2014	0	—	0
2015	2	—	0
2016	3	250	0
2017	4	109	0
2018	4	131	0
2019	4	262	0
2020	6	104	0
2021	4	137	0
2022	8	203	0
2023	10	132	0
2024	4	153	1
2025	3	89	0
2026	6	236	—

What is it indicated for?

The HL 200 ELECTRONIC STETHOSCOPE is intended for medical diagnostic purposes only. It can be used for the amplification heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050169 · printed Nov 4, 2026

Cite this page

510(k) Report. “K050169: HL 200 Electronic Stethoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050169

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026