510(k) · Cleared
ClearedCardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imediplus, Inc. · DQD Stethoscope, Electronic
Cleared on Sep 11, 2018 as substantially equivalent to K173663 (Imediplus, Inc., 2018) and 1 other predicate after a 28-day review. Its family tree reaches back 7 generations to 1977.
- Decided
- Sep 11, 2018
- Review
- 28 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K771653 (1977). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK771653 Electronic Stethoscope3M Company · 1977
- 6 generations backK961848 3M Littmann Electronic StethoscopeMinnesota Mining and Mfg. Co. · 1997
- 5 generations backK041934 3M Littmann Electronic Stethoscope, Model 30003M Company · 2004
- 4 generations backK050159 Modification to: 3M Littmann Electronic Stethoscope, Model 30003M Company · 2005
- 3 generations backK083903 3M Littmann Electronic Stethoscope, Model 32003M Company · 2009
- 2 generations backK160023 Electronic Stethoscope DS301Imediplus, Inc. · 2016
- 1 generation backK173663 Electronic Stethoscope DS3011AImediplus, Inc. · 2018
- This deviceK182196 Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic…Imediplus, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K771653 | Electronic Stethoscope | 3M Company | 1977 | — |
| −6 | K961848 | 3M Littmann Electronic Stethoscope | Minnesota Mining and Mfg. Co. | 1997 | — |
| −5 | K041934 | 3M Littmann Electronic Stethoscope, Model 3000 | 3M Company | 2004 | — |
| −4 | K050159 | Modification to: 3M Littmann Electronic Stethoscope, Model 3000 | 3M Company | 2005 | — |
| −3 | K083903 | 3M Littmann Electronic Stethoscope, Model 3200 | 3M Company | 2009 | — |
| −2 | K160023 | Electronic Stethoscope DS301 | Imediplus, Inc. | 2016 | — |
| −1 | K173663 | Electronic Stethoscope DS3011A | Imediplus, Inc. | 2018 | — |
| 0 (this device) | K182196 | Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope… | Imediplus, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173663 | Electronic Stethoscope DS3011A Cleared while this submission was under review Summary page 4…rimary IMEDIPLUS Electronic Stethoscope IMEDIPLUS DQD Predicate DS3011A INC. 870.1875 K173663 Secondary 3MTM LITTMANN® ELECTRONIC DQD Predicate 3M COMPANY… | 2018 |
| * | K083903 | 3M Littmann Electronic Stethoscope, Model 3200Summary page 4…ry 3MTM LITTMANN® ELECTRONIC DQD Predicate 3M COMPANY STETHOSCOPE MODEL 3200 870.1875 K083903 This Secondary Predicate K083903 with the same intended use, classification and product code as the proposed device is included… | 2009 |
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 41 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · DQD
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQD
89in 2025
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 6 | 161 | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 107 | 0 | 1 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 5 | 70 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 250 | 0 | 0 |
| 2017 | 4 | 109 | 0 | 0 |
| 2018 | 4 | 131 | 0 | 0 |
| 2019 | 4 | 262 | 0 | 0 |
| 2020 | 6 | 104 | 0 | 0 |
| 2021 | 4 | 137 | 0 | 0 |
| 2022 | 8 | 203 | 0 | 0 |
| 2023 | 10 | 132 | 0 | 0 |
| 2024 | 4 | 153 | 0 | 1 |
| 2025 | 3 | 89 | 0 | 0 |
| 2026 | 6 | 236 | 0 | — |
What is it indicated for?
The Electronic Stethoscope DS101 is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes…
Read the full statement (142 words)
The Electronic Stethoscope DS101 is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
The Electronic Stethoscope Omni-Steth is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182196: Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182196
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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