510(k) · Cleared
ClearedExtended Measurements System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inovise Medical, Inc. · DQD Stethoscope, Electronic
Cleared on Nov 10, 2005 as substantially equivalent to K043074 (Inovise Medical, Inc., 2005) after a 161-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Nov 10, 2005
- Review
- 161 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K920626 (1992). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK920626 Model Eli 200 ElectrocardiographMortara Instrument, Inc. · 1992
- 3 generations backK031182 Eli 200+ AudicorMortara Instrument, Inc. · 2003
- 2 generations backK032145 Audicor Upgrade SystemInovise Medical, Inc. · 2003
- 1 generation backK043074 Liberty SystemInovise Medical, Inc. · 2005 · Recalled
- This deviceK051450 Extended Measurements SystemInovise Medical, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK070136 Audicor 200 System, Models 200D and 200SInovise Medical, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K070136Audicor 200 System, Models 200D and 200SInovise Medical, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920626 | Model Eli 200 Electrocardiograph | Mortara Instrument, Inc. | 1992 | — |
| −3 | K031182 | Eli 200+ Audicor | Mortara Instrument, Inc. | 2003 | — |
| −2 | K032145 | Audicor Upgrade System | Inovise Medical, Inc. | 2003 | — |
| −1 | K043074 | Liberty System | Inovise Medical, Inc. | 2005 | 1 |
| 0 (this device) | K051450 | Extended Measurements System | Inovise Medical, Inc. | 2005 | — |
| +1 | K070136 | Audicor 200 System, Models 200D and 200S | Inovise Medical, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K043074 | Liberty SystemSummary page 2…(k) Submission Substantial The Inovise Medical Extended Measurements System is substantially equivalent to Equivalence: the AUDICOR® 200 system (K043074, cleared as Liberty). Technological The Extended Measurements System and the AUDICOR predicate device are Characterist… | 2005 |
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 |
|---|---|---|---|
| K070136 | Audicor 200 System, Models 200D and 200S | 2007 | 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 13 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K070136 (Inovise Medical, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K043074.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Extended Measurements System, when used with Audicor Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated COR report for consideration by physicians. In addition, the data can be presented in the format of real-time and trended display of cardiac indices derived from simultaneous ECG data and heart sounds data. The Extended Measurements…
Read the full statement (149 words)
The Extended Measurements System, when used with Audicor Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated COR report for consideration by physicians. In addition, the data can be presented in the format of real-time and trended display of cardiac indices derived from simultaneous ECG data and heart sounds data.
The Extended Measurements System can be used as an add-on device to work in conjunction with an Audicor-enabled device, or as a stand-alone electrocardiograph.
The interpretations of ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data.
The device is intended for use only under the direct supervision of a physician, and is for use on adults (> 18 years).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051450: Extended Measurements System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051450
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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