510(k) · Cleared
ClearedCliniCloud Stethoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stethocloud Pty.Ltd (Clinicloud) · DQD Stethoscope, Electronic
Cleared on Jan 25, 2018 as substantially equivalent to K050159 (3M Company, 2005) after an 80-day review. Its family tree reaches back 4 generations to 1977. 20 later devices descend from it.
- Decided
- Jan 25, 2018
- Review
- 80 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K771653 (1977). 5 ancestors in all. 20 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK771653 Electronic Stethoscope3M Company · 1977
- 3 generations backK961848 3M Littmann Electronic StethoscopeMinnesota Mining and Mfg. Co. · 1997
- 2 generations backK041934 3M Littmann Electronic Stethoscope, Model 30003M Company · 2004
- 1 generation backK050159 Modification to: 3M Littmann Electronic Stethoscope, Model 30003M Company · 2005
- This deviceK173448 CliniCloud StethoscopeStethocloud Pty.Ltd (Clinicloud) · 2018
- Descendant · cites it directly · 19 of its ownK181612 Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018
- Descendant · 2 generations on · 13 of its ownK200776 Eko COREEko Devices, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK231551 StethophoneSparrow Acoustics, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK210736 doctorgram Stethoscope DES-IGv Concepts · 2021
- Descendant · 4 generations on · 1 of its ownK240901 StethophoneSparrow Acoustics, Inc. · 2024
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K181612Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018 · cites it directly19descendants
- K200776Eko COREEko Devices, Inc. · 2020 · 2 generations on13descendants
- K231551StethophoneSparrow Acoustics, Inc. · 2023 · 3 generations on2descendants
- K210736doctorgram Stethoscope DES-IGv Concepts · 2021 · 3 generations on2descendants
- K240901StethophoneSparrow Acoustics, Inc. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K771653 | Electronic Stethoscope | 3M Company | 1977 | — |
| −3 | K961848 | 3M Littmann Electronic Stethoscope | Minnesota Mining and Mfg. Co. | 1997 | — |
| −2 | K041934 | 3M Littmann Electronic Stethoscope, Model 3000 | 3M Company | 2004 | — |
| −1 | K050159 | Modification to: 3M Littmann Electronic Stethoscope, Model 3000 | 3M Company | 2005 | — |
| 0 (this device) | K173448 | CliniCloud Stethoscope | Stethocloud Pty.Ltd (Clinicloud) | 2018 | — |
| +1 | K181612 | Tyto Stethoscope (OTC) | Tyto Care, Ltd. | 2018 | — |
| +2 | K200776 | Eko CORE | Eko Devices, Inc. | 2020 | — |
| +3 | K231551 | Stethophone | Sparrow Acoustics, Inc. | 2023 | — |
| +3 | K210736 | doctorgram Stethoscope DES-I | Gv Concepts | 2021 | — |
| +4 | K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (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 | Decided |
|---|---|---|---|
| * | K050159 | Modification to: 3M Littmann Electronic Stethoscope, Model 3000Summary page 5…Code: DQD Device Class: Class II Classification Panel: Cardiovascular 5. Legally Marketed Predicate Device: K050159, 3M™ Littmann® Electronic Stethoscope, 3M Health Care. Primary Predicate. We have identified “K083903, 3M™ Littmann® Electron… | 2005 |
| † | K083903 | 3M Littmann Electronic Stethoscope, Model 3200 | 2009 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181612 | Tyto Stethoscope (OTC) | 2018 | 19 |
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 12.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K181612 (Tyto Care, Ltd., 2018) has gone furthest, with 19 descendants of its own.
- 2 other devices also cite its predicate K050159.
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 CliniCloud Stethoscope is a digital stethoscope intended for periodic recording of lung and heart sounds to a smartphone device, via the CliniCloud app. It is intended to be used for persons of all ages. The device is for medical diagnostics purposes only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173448: CliniCloud Stethoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173448
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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