510(k) · Cleared
ClearedSpacelabs Healthcare Cardioexpress
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Healthcare, Ltd. · DPS Electrocardiograph
Cleared on Jul 23, 2013 as substantially equivalent to K090367 (Edan Instruments, Inc., 2009) and 1 other predicate after a 176-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Jul 23, 2013
- Review
- 176 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K921669 (1993). 14 ancestors in all, the oldest K820885 (1982). No later device cites it as a predicate yet.
- 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 backK091513 Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B…Edan Instruments, Inc. · 2009 · Recalled
- This deviceK130207 Spacelabs Healthcare CardioexpressSpacelabs Healthcare, Ltd. · 2013
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 | K091513 | Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6… | Edan Instruments, Inc. | 2009 | 1 |
| 0 (this device) | K130207 | Spacelabs Healthcare Cardioexpress | Spacelabs Healthcare, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 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 |
|---|---|---|---|
| * | K090367 | SE-601 Series ElectrocardiographSummary page 2…Predicate Predicate Equivalent Devices: 5 10(k) Number Mlan ufacturer /Model Spacelabs Healthcare K090367 Edan Instruments, Inc. / CardioExpress. Models SE-601 Series… | 2009 |
| * | K091513 | Smart Ecg Series Electrocardiograph, Models SE-3, SE-300A and 300B, SE-6, SE-600, SE-12…Summary page 2…98400-SL3-IEC, Electrocardiograph 98400-SL3-AHA. 98400-SL6-IEC. K091 513 Edan Instruments. Inc. / 98400-SL.6-AHA, SE-3, SE-300A, SE-300B3.… | 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 20 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 2 other devices also cite its predicate K090367.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 intended use of the Spacelabs Healthcare CardicExpress (CardicExpress) is to acquire ECG signals from adult and pediatric patients using ECG electrodes. CardiaExpress is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by CardioExpress can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements are only intended to be used on adult patients, and is offered to clinicians on an advisory basis only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130207: Spacelabs Healthcare Cardioexpress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130207
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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