510(k) · Cleared
ClearedSignal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zargis Medical Corp. · DQD Stethoscope, Electronic
Cleared on Aug 7, 2009 as substantially equivalent to K990809 (Caditec AG, 1999) and 2 other predicates after a 163-day review. Its family tree reaches back 4 generations to 1977. 1 later device descends from it.
- Decided
- Aug 7, 2009
- Review
- 163 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K771653 (1977). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK771653 Electronic Stethoscope3M Company · 1977
- 3 generations backK961857 Labtron Electromax Electronic Stethoscope Model NO. 04-1060Graham-Field, Inc. · 1996
- 2 generations backK991367 Meditron Stethoscope SystemMeditron AS · 1999
- 1 generation backK013725 Meditron II Thesterthoscope SystemMeditron AS · 2002
- This deviceK090493 SignalZargis Medical Corp. · 2009
- Descendant · cites it directly · 0 of its ownK100531 Viscope, Model 100P,100SHd Medical Services (India) Pvt.Ltd · 2010
Most influential descendants
Showing 1 of 1 · See all- K100531Viscope, Model 100P,100SHd Medical Services (India) Pvt.Ltd · 2010 · cites it directly0descendants
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 | K961857 | Labtron Electromax Electronic Stethoscope Model NO. 04-1060 | Graham-Field, Inc. | 1996 | — |
| −2 | K991367 | Meditron Stethoscope System | Meditron AS | 1999 | — |
| −1 | K013725 | Meditron II Thesterthoscope System | Meditron AS | 2002 | — |
| 0 (this device) | K090493 | Signal | Zargis Medical Corp. | 2009 | — |
| +1 | K100531 | Viscope, Model 100P,100S | Hd Medical Services (India) Pvt.Ltd | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K990809 | Cadiscope Electronic StethoscopeSummary page 1…ident/CEO Date Prepared: February 20, 2009 Predicate Devices: 1) CADIscope Electronic Stethoscope and Integrated ECG, K990809 2) eStation Model DR200 Electronic Stethoscope, K001788 3) Meditron II,… | 1999 |
| * | K001788 | Estation Electronic Stethoscope, Model DR200Summary page 1…1) CADIscope Electronic Stethoscope and Integrated ECG, K990809 2) eStation Model DR200 Electronic Stethoscope, K001788 3) Meditron II, thestethoscope system, K013725 Device Description: Signal Tm is an electronic auscu… | 2000 |
| * | K013725 | Meditron II Thesterthoscope SystemSummary page 1…K990809 2) eStation Model DR200 Electronic Stethoscope, K001788 3) Meditron II, thestethoscope system, K013725 Device Description: Signal Tm is an electronic auscultation device intended to acquire, record, and display heart sounds and oth… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100531 | Viscope, Model 100P,100S | 2010 | 0 |
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 32 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K100531 (Hd Medical Services (India) Pvt.Ltd, 2010) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K990809.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Signal is an electronic device intended to support the physician in the evaluation of heart sounds, lung sounds, bowel sounds and other acoustic signals in patients. The device allows for the recording of multiple, simultaneous acoustic signals and includes a single-lead electrocardiograph that produces a visual display of the electrocardiogram (ECG) on the PC monitor to enable the healthcare practitioner to synchronize the phonocardiogram with the…
Read the full statement (112 words)
Signal is an electronic device intended to support the physician in the evaluation of
heart sounds, lung sounds, bowel sounds and other acoustic signals in patients. The
device allows for the recording of multiple, simultaneous acoustic signals and
includes a single-lead electrocardiograph that produces a visual display of the
electrocardiogram (ECG) on the PC monitor to enable the healthcare practitioner to
synchronize the phonocardiogram with the beginning of the heart cycle. The ECG is
not intended for diagnostic use. The device also allows the sharing of data through the
Internet and provides a means to attach patient information to the stored sound files.
Signal is intended for use by healthcare professionals only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090493 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090493: Signal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090493
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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