510(k) · Cleared
ClearedCardiovision Software, Model S-CV5-96
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shl Telemedicine International, Ltd. · DPS Electrocardiograph
Cleared on Aug 19, 1998 as substantially equivalent to K955891 (Micromedical, Inc., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Aug 19, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K925639 (1993). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K955891 | Cardioview Transtelephonic SoftwareSummary page 1…ge Software Classification Name: Electrocardiograph (21 CFR 870.2340) Predicate Device: The predicate devices are the Micromedical Cardioview Transtelephonic Software (k955891) and the Instromedix Cardiomagic Software (k925639). Device Description: The Cardio Vision software is a program which runs on… | 1996 |
| * | K925639 | Cardiomagic SoftwareSummary page 1…(21 CFR 870.2340) Predicate Device: The predicate devices are the Micromedical Cardioview Transtelephonic Software (k955891) and the Instromedix Cardiomagic Software (k925639). Device Description: The Cardio Vision software is a program which runs on a personal computer and is used for the display and… | 1993 |
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 5 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- None of the 2 ancestors has a recall.
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?
VISUALIZATION AND MEASUREMENT OF ECG RECORDINGS TO BE USED BY TRAINED MEDICAL STAFF IN THE MONITORING OF CARDIAC CONDITION.
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/K981807 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981807: Cardiovision Software, Model S-CV5-96.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981807
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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