510(k) · Cleared
ClearedAudicor Upgrade 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 Oct 31, 2003 as substantially equivalent to K031182 (Mortara Instrument, Inc., 2003) after a 109-day review. Its family tree reaches back 2 generations to 1992. 13 later devices descend from it.
- Decided
- Oct 31, 2003
- Review
- 109 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920626 (1992). 3 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK920626 Model Eli 200 ElectrocardiographMortara Instrument, Inc. · 1992
- 1 generation backK031182 Eli 200+ AudicorMortara Instrument, Inc. · 2003
- This deviceK032145 Audicor Upgrade SystemInovise Medical, Inc. · 2003
- Descendant · cites it directly · 8 of its ownK112432 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · Recalled
- Descendant · 2 generations on · 4 of its ownK133269 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014
- Descendant · 2 generations on · 3 of its ownK121367 Zoll Propaq XMZOLL Medical Corporation · 2012 · Recalled
- Descendant · 3 generations on · 2 of its ownK180482 ZOLL Propaq MZOLL Medical Corporation · 2018
- Descendant · 3 generations on · 2 of its ownK141774 Zoll X SeriesZOLL Medical Corporation · 2014
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K112432Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · cites it directly8descendants
- K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014 · 2 generations on4descendants
- K121367Zoll Propaq XMZOLL Medical Corporation · 2012 · 2 generations on3descendants
- K180482ZOLL Propaq MZOLL Medical Corporation · 2018 · 3 generations on2descendants
- K141774Zoll X SeriesZOLL Medical Corporation · 2014 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920626 | Model Eli 200 Electrocardiograph | Mortara Instrument, Inc. | 1992 | — |
| −1 | K031182 | Eli 200+ Audicor | Mortara Instrument, Inc. | 2003 | — |
| 0 (this device) | K032145 | Audicor Upgrade System | Inovise Medical, Inc. | 2003 | — |
| +1 | K112432 | Zoll X Series | Zoll Medical Corporation, World Wide Headquarters | 2012 | 2 |
| +2 | K133269 | Zoll X Series | Zoll Medical Corporation, World Wide Headquarters | 2014 | — |
| +2 | K121367 | Zoll Propaq XM | ZOLL Medical Corporation | 2012 | 1 |
| +3 | K180482 | ZOLL Propaq M | ZOLL Medical Corporation | 2018 | — |
| +3 | K141774 | Zoll X Series | ZOLL Medical Corporation | 2014 | — |
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 | 2 | 0 |
| 2007 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 4 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K031182 | Eli 200+ Audicor Cleared while this submission was under review | 2003 |
What descends from it? (13)
See all 133 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)
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 11 years and passes through 2 companies; a new generation was cleared every 10.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K112432 (Zoll Medical Corporation, World Wide Headquarters, 2012) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K031182.
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 AudicorTM Upgrade System, when used with Audicor Sensors in the V3 and V4 positions on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sounds (phonocardiograph) data and to provide interpretation of the data for consideration by physicians. The Audicor System is an add-on device designed to work with the following electrocardiographs: GE Mac 8 GE Mac Vu GE Mac 5000 Philips Pagewriter XL The interpretations of…
Read the full statement (126 words)
The AudicorTM Upgrade System, when used with Audicor Sensors in the V3 and V4 positions on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sounds (phonocardiograph) data and to provide interpretation of the data for consideration by physicians.
The Audicor System is an add-on device designed to work with the following electrocardiographs:
GE Mac 8
GE Mac Vu
GE Mac 5000
Philips Pagewriter XL
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 all 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/K032145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032145: Audicor Upgrade System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032145
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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