510(k) Report

510(k) · Cleared

Cleared

3M Littmann Electronic Stethoscope, Model 3000

K041934510(k) TraditionalCleared Oct 15, 200488-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

3M Company · DQD Stethoscope, Electronic

Cleared on Oct 15, 2004 as substantially equivalent to K003723 (3M Company, 2001) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 1977. 50 later devices descend from it.

Decided
Oct 15, 2004
Review
88 days
Class
Class II
Product code
DQD
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K771653 (1977). 3 ancestors in all. 50 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2012: 1 descendant cleared2007: 1 descendant cleared2005: 1 descendant cleared2018: 5 descendants cleared2009: 1 descendant cleared2023: 7 descendants cleared2016: 3 descendants cleared2019: 3 descendants cleared2026: 5 descendants cleared2010: 1 descendant cleared2013: 1 descendant cleared2020: 4 descendants cleared2017: 1 descendant cleared2022: 7 descendants cleared2021: 3 descendants cleared2025: 3 descendants cleared2024: 3 descendants clearedK771653 · Electronic Stethoscope · 3M Company · 1977K961848 · 3M Littmann Electronic Stethoscope · Minnesota Mining and Mfg. Co. · 199719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 17 descendants4 generations forward: 15 descendants5 generations forward: 9 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant K961848 · 3M Littmann Electronic Stethoscope · Minnesota Mining and Mfg. Co. · 1997K771653 · Electronic Stethoscope · 3M Company · 19770+5
  1. Root · 2 generations backK771653 Electronic Stethoscope3M Company · 1977
  2. 1 generation backK961848 3M Littmann Electronic StethoscopeMinnesota Mining and Mfg. Co. · 1997
  3. This deviceK041934 3M Littmann Electronic Stethoscope, Model 30003M Company · 2004
  4. Descendant · cites it directly · 48 of its ownK050159 Modification to: 3M Littmann Electronic Stethoscope, Model 30003M Company · 2005
  5. Descendant · 2 generations on · 46 of its ownK083903 3M Littmann Electronic Stethoscope, Model 32003M Company · 2009
  6. Descendant · 3 generations on · 21 of its ownK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
  7. Descendant · 2 generations on · 20 of its ownK173448 CliniCloud StethoscopeStethocloud Pty.Ltd (Clinicloud) · 2018
  8. Descendant · 3 generations on · 19 of its ownK181612 Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2005: 12007: 12009: 12010: 12012: 12013: 12016: 32017: 12018: 52019: 32020: 42021: 32022: 72023: 72024: 32025: 32026: 5
2005high 7 (2022) · low 0 (2006)2026

Most influential descendants

Showing 5 of 50 · See all
  • K050159Modification to: 3M Littmann Electronic Stethoscope, Model 30003M Company · 2005 · cites it directly48descendants
  • K0839033M Littmann Electronic Stethoscope, Model 32003M Company · 2009 · 2 generations on46descendants
  • K160401Tyto StethoscopeTyto Care, Ltd. · 2016 · 3 generations on21descendants
  • K173448CliniCloud StethoscopeStethocloud Pty.Ltd (Clinicloud) · 2018 · 2 generations on20descendants
  • K181612Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018 · 3 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K771653Electronic Stethoscope3M Company1977—
−1K9618483M Littmann Electronic StethoscopeMinnesota Mining and Mfg. Co.1997—
0 (this device)K0419343M Littmann Electronic Stethoscope, Model 30003M Company2004—
+1K050159Modification to: 3M Littmann Electronic Stethoscope, Model 30003M Company2005—
+2K0839033M Littmann Electronic Stethoscope, Model 32003M Company2009—
+3K160401Tyto StethoscopeTyto Care, Ltd.2016—
+2K173448CliniCloud StethoscopeStethocloud Pty.Ltd (Clinicloud)2018—
+3K181612Tyto Stethoscope (OTC)Tyto Care, Ltd.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
200910
201010
201210
201310
201630
201710
201850
201930
202040
202130
202270
202370
202430
202530
202650
FIG. 1 — Lineage of K041934, 1977–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K200776 Eko COREscore 25.2 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K0037233M Littmann
Summary page 3
…submission is composed of similar materials, and has similar performance features, intended use and indications for use as the Model 4000 cleared under K003723, and the Model 2000, cleared under K961848. Comparison of Performance Features Littmann®Electronic Stethosco…
3M Company2001—
*K9618483M Littmann Electronic Stethoscope
Summary page 3
…, and has similar performance features, intended use and indications for use as the Model 4000 cleared under K003723, and the Model 2000, cleared under K961848. Comparison of Performance Features Littmann®Electronic Stethoscope Model 3000 versus Littmann®Electronic St…
Minnesota Mining and Mfg. Co.1997—

Also cleared against K003723: 4 other devices →

What descends from it? (50)

See all 50

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050159Modification to: 3M Littmann Electronic Stethoscope, Model 30003M Company200548
K121144Electronic StethoscopeSharp Corporation20120
K070550Ausco ES-3100Koratek Company, Ltd.20070

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 27 years and passes through 2 companies; a new generation was cleared every 20.0 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K050159 (3M Company, 2005) has gone furthest, with 48 descendants of its own.
  • 4 other devices also cite its predicate K003723.

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

2007: 22008: 12009: 62010: 12011: 42012: 22013: 52015: 22016: 32017: 42018: 42019: 42020: 62021: 42022: 82023: 102024: 42025: 32026 (partial year): 6
2007high 10 (2023) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQD

89in 2025

2009: 161 days median2011: 107 days median2013: 70 days median2016: 250 days median2017: 109 days median2018: 131 days median2019: 262 days median2020: 104 days median2021: 137 days median2022: 203 days median2023: 132 days median2024: 153 days median2025: 89 days median2026 (partial year): 236 days median
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

2011: 12013: 12024: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20081—00
2009616100
20101—00
2011410701
20122—00
201357001
20140—00
20152—00
2016325000
2017410900
2018413100
2019426200
2020610400
2021413700
2022820300
20231013200
2024415301
202538900
202662360—

What is it indicated for?

The 3MTM Littmann ® Electronic Stethoscope Model 3000 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of heart, lungs, arteries, veins, and other internal organs with the use of a selective frequency. It can be used on any person undergoing a physical assessment.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K041934: 3M Littmann Electronic Stethoscope, Model 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041934

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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