510(k) Report

510(k) · Cleared

Cleared

E-Scope Electronic Stethoscope Model 718-7120

K961301510(k) TraditionalCleared Jun 11, 199668-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

Delphi Consulting Group · DQD Stethoscope, Electronic

Cleared on Jun 11, 1996 after a 68-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 112 later devices descend from it.

Decided
Jun 11, 1996
Review
68 days
Class
Class II
Product code
DQD
Recalls
None
Predicates
0

112 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2006: 4 descendants cleared2011: 8 descendants cleared1999: 2 descendants cleared2003: 2 descendants cleared2008: 5 descendants cleared2009: 3 descendants cleared2002: 2 descendants cleared2005: 3 descendants cleared2010: 7 descendants cleared2007: 3 descendants cleared2023: 12 descendants cleared2013: 4 descendants cleared2012: 3 descendants cleared2015: 4 descendants cleared2017: 3 descendants cleared2016: 3 descendants cleared2018: 4 descendants cleared2014: 2 descendants cleared2019: 3 descendants cleared2020: 5 descendants cleared2021: 5 descendants cleared2026: 10 descendants cleared2025: 5 descendants cleared2022: 6 descendants cleared2024: 4 descendants cleared1995200020052010201520202025
  1. This deviceK961301 E-Scope Electronic Stethoscope Model 718-7120Delphi Consulting Group · 1996
  2. Descendant · cites it directly · 66 of its ownK990809 Cadiscope Electronic StethoscopeCaditec AG · 1999
  3. Descendant · cites it directly · 51 of its ownK991367 Meditron Stethoscope SystemMeditron AS · 1999
  4. Descendant · 2 generations on · 46 of its ownK013434 VP-2000/1000Colin Corp. · 2002
  5. Descendant · 2 generations on · 29 of its ownK072026 RNK Electronic StethoscopeRnk Products, Inc. · 2007
  6. Descendant · 3 generations on · 27 of its ownK082357 Microlife Upper Arm Automatic Digital Blood Pressure Monitor…Microlife Intellectual Property GmbH · 2008

Showing 5 of 112 descendants. See all descendants

Descendants cleared per year

1999: 22002: 22003: 22005: 32006: 42007: 32008: 52009: 32010: 72011: 82012: 32013: 42014: 22015: 42016: 32017: 32018: 42019: 32020: 52021: 52022: 62023: 122024: 42025: 52026: 10
1999high 12 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 112 · See all
  • K990809Cadiscope Electronic StethoscopeCaditec AG · 1999 · cites it directly66descendants
  • K991367Meditron Stethoscope SystemMeditron AS · 1999 · cites it directly51descendants
  • K013434VP-2000/1000Colin Corp. · 2002 · 2 generations on46descendants
  • K072026RNK Electronic StethoscopeRnk Products, Inc. · 2007 · 2 generations on29descendants
  • K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp Office…Microlife Intellectual Property GmbH · 2008 · 3 generations on27descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K961301E-Scope Electronic Stethoscope Model 718-7120Delphi Consulting Group1996—
+1K990809Cadiscope Electronic StethoscopeCaditec AG1999—
+1K991367Meditron Stethoscope SystemMeditron AS1999—
+2K013434VP-2000/1000Colin Corp.2002—
+2K072026RNK Electronic StethoscopeRnk Products, Inc.2007—
+3K082357Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Modelwatchbp…Microlife Intellectual Property GmbH2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200220
200320
200530
200640
200730
200850
200930
201070
201180
201230
201340
201420
201540
201630
201730
201840
201930
202050
202150
202260
2023120
202440
202550
2026100
FIG. 1 — Lineage of K961301, 1996–2026Source: 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), 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (112)

See all 112

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

NumberDeviceApplicantDecidedDescendants
K990809Cadiscope Electronic StethoscopeCaditec AG199966
K991367Meditron Stethoscope SystemMeditron AS199951
K060194March Healthcare Health Monitoring KitMarch Healthcare Corporation20065
K030316Audicor Cor Sensor (and Accessory Adaptor)Inovise Medical, Inc.20032
K103499A ScopeActive Signal Technologies, Inc.20110

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?

  • Of its descendants, K990809 (Caditec AG, 1999) has gone furthest, with 66 descendants of its own.

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—
Cite this page

510(k) Report. “K961301: E-Scope Electronic Stethoscope Model 718-7120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961301

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026