510(k) · Cleared
ClearedSteth IO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stratoscientific, Inc. · DQD Stethoscope, Electronic
Cleared on Jul 15, 2016 as substantially equivalent to K083903 (3M Company, 2009) after a 192-day review. Its family tree reaches back 5 generations to 1977. 4 later devices descend from it.
- Decided
- Jul 15, 2016
- Review
- 192 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K771653 (1977). 7 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK771653 Electronic Stethoscope3M Company · 1977
- 4 generations backK961848 3M Littmann Electronic StethoscopeMinnesota Mining and Mfg. Co. · 1997
- 3 generations backK041934 3M Littmann Electronic Stethoscope, Model 30003M Company · 2004
- 2 generations backK050159 Modification to: 3M Littmann Electronic Stethoscope, Model 30003M Company · 2005
- 1 generation backK083903 3M Littmann Electronic Stethoscope, Model 32003M Company · 2009
- This deviceK160016 Steth IOStratoscientific, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK222871 Stethophone v1Sparrow Acoustics, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK231551 StethophoneSparrow Acoustics, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK240901 StethophoneSparrow Acoustics, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK252595 Stethophone ProSparrow Acoustics, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K222871Stethophone v1Sparrow Acoustics, Inc. · 2023 · cites it directly3descendants
- K231551StethophoneSparrow Acoustics, Inc. · 2023 · 2 generations on2descendants
- K240901StethophoneSparrow Acoustics, Inc. · 2024 · 3 generations on1descendant
- K252595Stethophone ProSparrow Acoustics, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K771653 | Electronic Stethoscope | 3M Company | 1977 | — |
| −4 | K961848 | 3M Littmann Electronic Stethoscope | Minnesota Mining and Mfg. Co. | 1997 | — |
| −3 | K041934 | 3M Littmann Electronic Stethoscope, Model 3000 | 3M Company | 2004 | — |
| −2 | K050159 | Modification to: 3M Littmann Electronic Stethoscope, Model 3000 | 3M Company | 2005 | — |
| −1 | K083903 | 3M Littmann Electronic Stethoscope, Model 3200 | 3M Company | 2009 | — |
| 0 (this device) | K160016 | Steth IO | Stratoscientific, Inc. | 2016 | — |
| +1 | K222871 | Stethophone v1 | Sparrow Acoustics, Inc. | 2023 | — |
| +2 | K231551 | Stethophone | Sparrow Acoustics, Inc. | 2023 | — |
| +3 | K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024 | — |
| +4 | K252595 | Stethophone Pro | Sparrow Acoustics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K083903 | 3M Littmann Electronic Stethoscope, Model 3200Summary page 5…undergoing a physical assessment. Population: Contraindications: Open skin lesions at site of examination 10. Predicate Device(s): 510(k) Number: K083903 Manufacturer: 3M Company Trade Name: 3M Littmann Electronic S… | 2009 |
| † | K100531 | Viscope, Model 100P,100S | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222871 | Stethophone v1 | 2023 | 3 |
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 39 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K222871 (Sparrow Acoustics, Inc., 2023) has gone furthest, with 3 descendants of its own.
- 16 other devices also cite its predicate K083903.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 StratoScientific Steth 10 Stethoscope and Phonocardiogram Model 1.0 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, and lungs with the use of selective frequency ranges. It has been tested for use on adults undergoing a physical assessment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160016: Steth IO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160016
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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