510(k) · Cleared
ClearedA Scope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Active Signal Technologies, Inc. · DQD Stethoscope, Electronic
Cleared on Mar 31, 2011 as substantially equivalent to K973336 (Imex Medical Systems, Inc., 1998) and 2 other predicates after a 122-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Mar 31, 2011
- Review
- 122 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K910462 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK910462 Pocket Dop 3Imex Medical Systems, Inc. · 1991
- This deviceK103499 A ScopeActive Signal Technologies, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910462 | Pocket Dop 3 | Imex Medical Systems, Inc. | 1991 | — |
| 0 (this device) | K103499 | A Scope | Active Signal Technologies, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K973336 | Imex StethodopSummary page 2…Devices Considered confidential (21 CFR Yes 807.950) Reviewed By Third Party NO Squbstantial K973336, IMEX Stethodop, (eqiane K961301, E-Scope and K91 0462 (Pedicae Pocket DOP-3 3. Predicate Devic… | 1998 |
| * | K910462 | Pocket Dop 3Summary page 2…Yes 807.950) Reviewed By Third Party NO Squbstantial K973336, IMEX Stethodop, (eqiane K961301, E-Scope and K91 0462 (Pedicae Pocket DOP-3 3. Predicate Devices: The A SCOPE~m stethoscope is substantially equivalent to other… | 1991 |
| * | K961301 | E-Scope Electronic Stethoscope Model 718-7120Summary page 2…(21 CFR Yes 807.950) Reviewed By Third Party NO Squbstantial K973336, IMEX Stethodop, (eqiane K961301, E-Scope and K91 0462 (Pedicae Pocket DOP-3 3. Predicate Devices: The A SCOPE~m stethoscope is substantially… | 1996 |
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?
- None of the 3 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. 2011, 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 Active Signal A SCOPE (or noise-immune stethoscope) is intended for medical diagnostic purposes only. It may be used for the detection and amplification of acoustic signals generated by physiologic activity in the body. In the presence of relatively mild ambient noise it is used in Acoustic Mode and functions as a passive electronic stethoscope to receive sounds produced by the heart, lungs, bowel and other internal organs. To retain audibility at…
Read the full statement (128 words)
The Active Signal A SCOPE (or noise-immune stethoscope) is intended for medical diagnostic purposes only. It may be used for the detection and amplification of acoustic signals generated by physiologic activity in the body. In the presence of relatively mild ambient noise it is used in Acoustic Mode and functions as a passive electronic stethoscope to receive sounds produced by the heart, lungs, bowel and other internal organs. To retain audibility at higher sound levels it is switched to Doppler Mode where an audible tone is produced by the ultrasound frequency-shift caused by motion of the heart and lungs.
It can be used on any person undergoing a physical assessment. It is not intended to be used for diagnosis and treatment by unlicensed, untrained, or unqualified medical persons.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103499 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103499: A Scope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103499
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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