510(k) · Cleared
Recalled · 2003Liberty System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inovise Medical, Inc. · DPS Electrocardiograph
Cleared on Feb 22, 2005 as substantially equivalent to K032145 (Inovise Medical, Inc., 2003) and 1 other predicate after a 106-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it. It has been recalled once.
- Decided
- Feb 22, 2005
- Review
- 106 days
- Class
- Class II
- Product code
- DPS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K920626 (1992). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK920626 Model Eli 200 ElectrocardiographMortara Instrument, Inc. · 1992
- 2 generations backK031182 Eli 200+ AudicorMortara Instrument, Inc. · 2003
- 1 generation backK032145 Audicor Upgrade SystemInovise Medical, Inc. · 2003
- This deviceK043074 Liberty SystemInovise Medical, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK051450 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920626 | Model Eli 200 Electrocardiograph | Mortara Instrument, Inc. | 1992 | — |
| −2 | K031182 | Eli 200+ Audicor | Mortara Instrument, Inc. | 2003 | — |
| −1 | K032145 | Audicor Upgrade System | Inovise Medical, Inc. | 2003 | — |
| 0 (this device) | K043074 | Liberty System | Inovise Medical, Inc. | 2005 | — |
| +1 | 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 |
|---|---|---|
| 2005 | 1 | 0 |
| 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K032145 | Audicor Upgrade SystemSummary page 1…for Safety Substantial The Inovise Medical Liberty System is substantially equivalent to the Audicor Equivalence: Cardiograph Expansion system (K032145) and the Mortara Instrument ELI 200+ SumnmayS~afetyandEffectiveness… | 2003 |
| * | K031182 | Eli 200+ AudicorSummary page 2…stem 510(k) Submission with Audicor Electrocardiograph (K031 182). Technological The Liberty System and the predicate device are technologically equivalent in that Characteristics: both acqui… | 2003 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 12, 2003 | Not classified | Z-0565-06 | Other | Use of the AUDICOR 200 D in-line with a defibrillator/monitor resulted in interruption of pacing therapy to a patient when the AUDICOR 200 D stopped working due to low battery power. |
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.
- None of the 4 ancestors has a recall.
- Of its descendants, K051450 (Inovise Medical, Inc., 2005) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K032145.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The Liberty 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. The Liberty System can be used as an add-on device to work in conjunction with select cardiographs, defibrillators, and patient monitors; or as a stand-alone electrocardiograph. The interpretations of…
Read the full statement (123 words)
The Liberty 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.
The Liberty System can be used as an add-on device to work in conjunction with select cardiographs, defibrillators, and patient monitors; 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/K043074 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043074: Liberty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043074
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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