510(k) · Cleared
ClearedParace MD Ekoscope IS100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parace, LLC · DQD Stethoscope, Electronic
Cleared on Nov 19, 2013 as substantially equivalent to K051790 (3M Company, 2005) and 2 other predicates after a 410-day review. Its family tree reaches back 5 generations to 1977.
- Decided
- Nov 19, 2013
- Review
- 410 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K771653 (1977). 17 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK123148 Parace MD Ekoscope IS100Parace, LLC · 2013
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) | K123148 | Parace MD Ekoscope IS100 | Parace, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K051790 | 3M Littmann Electronic Stethoscope, Model 4100Summary page 1…Electrocardiograph Class 11(Two), 21 CFR 870.2340 Performance Standards: None Predicate Devices: 3 MTMLittmann ODElectronic Stethoscope, Model 4100, K051 790 3 MTMLittmann® Electronic Stethoscope, Model 3200, K083903 Edan SE-3 Series Electrocardiograph, K091 513 Device Description: The… | 2005 |
| * | K083903 | 3M Littmann Electronic Stethoscope, Model 3200Summary page 1…870.2340 Performance Standards: None Predicate Devices: 3 MTMLittmann ODElectronic Stethoscope, Model 4100, K051 790 3 MTMLittmann® Electronic Stethoscope, Model 3200, K083903 Edan SE-3 Series Electrocardiograph, K091 513 Device Description: The Ekoscope 5100 Device is an electronic stethoscope with 6 le… | 2009 |
| * | K091513 | Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12…Summary page 1…te Devices: 3 MTMLittmann ODElectronic Stethoscope, Model 4100, K051 790 3 MTMLittmann® Electronic Stethoscope, Model 3200, K083903 Edan SE-3 Series Electrocardiograph, K091 513 Device Description: The Ekoscope 5100 Device is an electronic stethoscope with 6 leads EKG capability. The electronic microphone… | 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 36 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 17 ancestors has a recall of any class.
- 1 other device also cites its predicate K051790.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 EKOSCOPE device is intended for medical diagnostic purposes only. It has an electronic stethoscope function with three modes of operation. It also has an electrocardiograph (EGG) function with three modes of operation. The Belle mode processes sounds having a frequency range of 20H-z to 5001-z. Secondly the Diaphragm made processes sound within a range of 20 Hz to 700 H~z. The third mode is the Diaphragm plus mode. The Diaphragm plus mode processes…
Read the full statement (290 words)
The EKOSCOPE device is intended for medical diagnostic purposes only. It has an electronic stethoscope function with three modes of operation. It also has an electrocardiograph (EGG) function with three modes of operation. The Belle mode processes sounds having a frequency range of 20H-z to 5001-z. Secondly the Diaphragm made processes sound within a range of 20 Hz to 700 H~z. The third mode is the Diaphragm plus mode. The Diaphragm plus mode processes mechanical heart sounds between 1KHz to 20KHz. The stethoscope function is used for the detection and amplification of sounds from the heart, lungs, arteries, veins and other Internal organs during physical assessment. It has a built-in penlight accessory with adjustable brightness used to visualize pupil, nasal and oral cavity..
The EGG mode utilizes one of three modes to detect cardiac electrical activities, specifically from the limb leads, to determine the state of the heart beyond the abilities of a stethoscope. The EGG are detectable by a series of electrodes markced as #1 and #2 as referred in the user manual to user manual to register, record and display the electrical activity of the cardiac cycle in real time. This assessment will allow for the medical professional to then analyze, interpret and diagnose heart rate and rhythm based on recorded limb lead electrocardiogram information. This ECG is not a standard 12-lead ECG and is not suitable for detection of ischemia or infarction. The EKOSCOPE Is suitable for adults and pediatrics but not intended for use on infants and in utero. The device is Intended for use In hospitals or healthcare facilities by doctors and trained health care professionals.
Caution: Federal Law restricts this device to sale by or on the order of a licensed health care practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123148: Parace MD Ekoscope IS100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123148
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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