510(k) Report

510(k) · Cleared

Cleared

3M Littmann Scope-to Scope Software System

K101834510(k) TraditionalCleared Sep 3, 201064-day reviewClass II21 CFR 870.2910

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

3M Company · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

Cleared on Sep 3, 2010 as substantially equivalent to K973873 (American Telecare, Inc., 1997) after a 64-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it.

Decided
Sep 3, 2010
Review
64 days
Class
Class II
Product code
DRG
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K952882 (1996). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2012: 1 descendant cleared2017: 1 descendant cleared×2: 2 generations cleared close together, K952882 (1996), K964554 (1996) K973873 · Digital Personal Telemedicine Module, Digital PTM 1 · American Telecare, Inc. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K973873 · Digital Personal Telemedicine Module, Digital PTM 1 · American Telecare, Inc. · 1997K964554 · Personal Telemedicine Module · American Telecare, Inc. · 1996K952882 · Personal Telemedicine System · American Telecare, Inc. · 19960
  1. Root · 3 generations backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
  2. 2 generations backK964554 Personal Telemedicine ModuleAmerican Telecare, Inc. · 1996
  3. 1 generation backK973873 Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997
  4. This deviceK101834 3M Littmann Scope-to Scope Software System3M Company · 2010
  5. Descendant · cites it directly · 1 of its ownK120704 3M Littmann Telesteth Online Ausculation System3M Company · 2012
  6. Descendant · 2 generations on · 0 of its ownK171188 Ossler Exam ScopeLr Med, Inc. · 2017

Most influential descendants

Showing 2 of 2 · See all
  • K1207043M Littmann Telesteth Online Ausculation System3M Company · 2012 · cites it directly1descendant
  • K171188Ossler Exam ScopeLr Med, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K952882Personal Telemedicine SystemAmerican Telecare, Inc.1996—
−2K964554Personal Telemedicine ModuleAmerican Telecare, Inc.1996—
−1K973873Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc.1997—
0 (this device)K1018343M Littmann Scope-to Scope Software System3M Company2010—
+1K1207043M Littmann Telesteth Online Ausculation System3M Company2012—
+2K171188Ossler Exam ScopeLr Med, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201710
FIG. 1 — Lineage of K101834, 1996–2017Source: 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 DRG? 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 DRG device

  1. #1 K223711 ANNE Onescore 20.8 · 11 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K973873Digital Personal Telemedicine Module, Digital PTM 1
Summary page 1
…gical signal, radiofrequency (21 CFR § 870.291 0) Performance Standards: N/A Predicate Device: CareTone® Telephonic Stethoscope (K973873 American TeleCare's Digital Personal Telemedicine Module) 510(k) Premarket Notification for 3MT" Littmann®D Scope…
American Telecare, Inc.1997—

Also cleared against K973873: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K1207043M Littmann Telesteth Online Ausculation System3M Company20121

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 14 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K120704 (3M Company, 2012) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K973873.

How does its category compare?

All DRG devices

DRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · DRG

3in 2025

2007: 62008: 52009: 132010: 102011: 92012: 122013: 132014: 102015: 22016: 22017: 72018: 62019: 52020: 62021: 22022: 62023: 42024: 32025: 32026 (partial year): 2
2007high 13 (2009) · low 2 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRG

127in 2025

2007: 63 days median2008: 74 days median2009: 94 days median2010: 68 days median2011: 104 days median2012: 103 days median2013: 146 days median2014: 177 days median2017: 98 days median2018: 220 days median2019: 122 days median2020: 159 days median2022: 287 days median2023: 212 days median2024: 125 days median2025: 127 days median
2007high 287 (2022) · low 63 (2007)2026

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

Recalls per year · DRG

3in 2007

2007: 32026 (partial year): 1
2007high 3 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRG

52in 2025

2007: 142008: 92009: 52010: 132011: 122012: 92013: 132014: 972015: 1312016: 1822017: 4842018: 1662019: 702020: 822021: 1072022: 432023: 192024: 262025: 52
2007high 484 (2017) · low 5 (2009)2025

MAUDE reports naming product code DRG, 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
2007663314
200857409
2009139405
20101068013
20119104012
20121210309
201313146013
201410177097
20152—0131
20162—0182
20177980484
201862200166
20195122070
20206159082
20212—0107
20226287043
20234212019
20243125026
20253127052
20262—1—

What is it indicated for?

The 3MT" Littmann®D Scope-to-Scope Software System is intended to provide and control the real time data transfer of body sounds between two 3A.TM- Littmann® Electronic Stethoscopes, Model 3200 over a data network. 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. “K101834: 3M Littmann Scope-to Scope Software System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101834

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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