510(k) · Cleared
ClearedCarecenter MD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Science Corporation · DPS Electrocardiograph
Cleared on Jun 3, 2010 as substantially equivalent to K024283 (Reynolds Medical, Ltd., 2003) and 3 other predicates after a 233-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it.
- Decided
- Jun 3, 2010
- Review
- 233 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K921669 (1993). 25 ancestors in all, the oldest K820885 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 4 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 3 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 2 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- 1 generation backK024283 Cardiodirect, Models 12M, 12I, 12SReynolds Medical, Ltd. · 2003
- This deviceK093211 Carecenter MDCardiac Science Corporation · 2010
- Descendant · cites it directly · 0 of its ownK123217 CardeascreenCardea Associates, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K123217CardeascreenCardea Associates, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −4 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −3 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −2 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| −1 | K024283 | Cardiodirect, Models 12M, 12I, 12S | Reynolds Medical, Ltd. | 2003 | — |
| 0 (this device) | K093211 | Carecenter MD | Cardiac Science Corporation | 2010 | — |
| +1 | K123217 | Cardeascreen | Cardea Associates, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (4)
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 |
|---|---|---|---|
| * | K024283 | Cardiodirect, Models 12M, 12I, 12SSummary page 1…_ __ _ _ _ _ __ _ _ _ __ _ _ _ _ __ _ _ _ __ _ _ _ _ Reynolds Medical Ltd. Herts CardioDirect EGG K024283 England GE Medical Systems Information CardioiSoft/CASE Cardiac… | 2003 |
| * | K031561 | Cardiosoft/Case Cardiac Testing SystemSummary page 1…K024283 England GE Medical Systems Information CardioiSoft/CASE Cardiac K031561 Technologies Milwaukee, WI Testing System ET Medical Devices Spa, Milan,… | 2003 |
| * | K051534 | Cardioline AR 600, AR 1200, AR 2100Summary page 1…Testing System ET Medical Devices Spa, Milan, Cardioline AR600 K051534 Italy Mortara Instrument, Inc. X-12 Telemetry Module EGG… | 2005 |
| * | K974149 | Ambulatory X-12 Telemetry ModuleSummary page 1…K051534 Italy Mortara Instrument, Inc. X-12 Telemetry Module EGG K974149 Milwaukee, WI Confidential 1017/09… | 1998 |
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 |
|---|---|---|---|
| K123217 | Cardeascreen | 2013 | 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 17 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K123217 (Cardea Associates, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K024283.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 Cardiac Science CareCenter MD is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner on adult and pediatric populations. The device is designed to acquire, display, process, record, analyze and output 12 lead ECG data during periods of physiological stress, induced through exercise or pharmacological means or during resting EGG testing. In addition, the CareCenter MD provides interfaces for…
Read the full statement (206 words)
The Cardiac Science CareCenter MD is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner on adult and pediatric populations. The device is designed to acquire, display, process, record, analyze and output 12 lead ECG data during periods of physiological stress, induced through exercise or pharmacological means or during resting EGG testing. In addition, the CareCenter MD provides interfaces for acquiring physiological data from ancillary devices (such as spirometry and blood pressure) and records EGG in real time with and without arrhythmia detection.
The system provides automatic interpretation of resting EGG on adult populations. No automatic interpretation of resting EGGs is provided for pediatric populations. Interpretive statements should be overviewed and approved by trained physicians.
The CareCenter MD may provide interfaces for the control of external devices such as a treadmill or an ergometer, and for communicating with centralized computer systems via a network. The device is intended to provide non-diagnostic patient data management functions as both a self-contained, stand-alone application and by interfacing with Electronic Medical Records systems.
The device is not intended to be used as a vital signs or long term physiological monitor. The CareCenter MD is not intended to be used as a transport device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093211 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093211: Carecenter MD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093211
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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