510(k) · Cleared
ClearedMida Algorithm Rev. B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortivus AB · DYC Vectorcardiograph
Cleared on Dec 5, 2003 as substantially equivalent to K896396 (Medical Graphics Corp., 1990) and 1 other predicate after a 420-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Dec 5, 2003
- Review
- 420 days
- Class
- Class II
- Product code
- DYC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K872781 (1987). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK872781 Easi Lead System Cable AssemblyTotemite Medical Electronics · 1987
- 2 generations backK990476 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model…Hewlett-Packard GmbH · 1999
- 1 generation backK992595 HP Viridia Component Monitoring System, Model Rev. K with Easi-ST…Hewlett-Packard GmbH · 1999
- This deviceK023414 Mida Algorithm Rev. BOrtivus AB · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K872781 | Easi Lead System Cable Assembly | Totemite Medical Electronics | 1987 | — |
| −2 | K990476 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, Model Rev. K… | Hewlett-Packard GmbH | 1999 | — |
| −1 | K992595 | HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment… | Hewlett-Packard GmbH | 1999 | — |
| 0 (this device) | K023414 | Mida Algorithm Rev. B | Ortivus AB | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 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 DYC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K896396 | Mida System, Models 1000/1100Summary page 1…vectorcardiogram from the five leads system EASI is substantially equivalent to the MIDATm System, Models 1000/1 100 manufactured by Medical Graphics Corporation (K896396) and the HP Viridia CMS (K992595). 3. Description of the Device: The new device is a modification that allows the MIDATm a… | 1990 |
| * | K992595 | HP Viridia Component Monitoring System, Model Rev. K with Easi-ST Segment Measurement…Summary page 1…eads system EASI is substantially equivalent to the MIDATm System, Models 1000/1 100 manufactured by Medical Graphics Corporation (K896396) and the HP Viridia CMS (K992595). 3. Description of the Device: The new device is a modification that allows the MIDATm algorithm to use vectorcardiogram… | 1999 |
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 16 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K896396.
How does its category compare?
All DYC devicesDYC Vectorcardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYC
FDA has decided no DYC device since 2007.
Median 510(k) review, days · DYC
Too few DYC 510(k)s in any year since 2007 to give a median.
Recalls per year · DYC
No recall names DYC since 2007.
Adverse event reports per year · DYC
No MAUDE report names DYC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For use only by a digital device to measure ST-segment shifts.
Assessment of real time ST segment analysis in adult patients.
The MIDATm Algorithm Rev. B is intended for use in the hospital environment for the following patient population:
Ages: 33-82 years
Heights: 147 to 185cm (58 to 73 in.)
Weights: 53 to 118kg (117 to 261 lbs.)
Height to weight ratios: 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb)
The use of EASI leads implies that the results may not be of diagnostic quality.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023414: Mida Algorithm Rev. B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023414
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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