510(k) · Cleared
ClearedCardiovit at-10PLUS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiller AG · DPS Electrocardiograph
Cleared on May 4, 2005 as substantially equivalent to K031557 (Schiller AG, 2004) after a 49-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- May 4, 2005
- Review
- 49 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953396 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK953396 Cardiovit at-1C, at-2CSchiller America, Inc. · 1995
- 1 generation backK031557 Cardiovit at-102Schiller AG · 2004
- This deviceK050686 Cardiovit at-10PLUSSchiller AG · 2005
- Descendant · cites it directly · 1 of its ownK152043 Diagnostic Station DS20Schiller AG · 2016
- Descendant · cites it directly · 0 of its ownK170182 Cardiovit FT-1Schiller AG · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953396 | Cardiovit at-1C, at-2C | Schiller America, Inc. | 1995 | — |
| −1 | K031557 | Cardiovit at-102 | Schiller AG | 2004 | — |
| 0 (this device) | K050686 | Cardiovit at-10PLUS | Schiller AG | 2005 | — |
| +1 | K152043 | Diagnostic Station DS20 | Schiller AG | 2016 | — |
| +1 | K170182 | Cardiovit FT-1 | Schiller AG | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K031557 | Cardiovit at-102Summary page 1…Name: Electrocardiographie Device A3 Legally Marketed Device Legally Marketed Device to which this submitted device is compared: AT-102 (K031 557) A4 Intended Use The AT-i OPlus is a 12-channel, EGG device used for the recording, analysis and evaluation of EGG recordi… | 2004 |
What descends from it? (2)
2 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 10 years and passes through 2 companies; a new generation was cleared every 8.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K152043 (Schiller AG, 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K031557.
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 AT-1 oPlus is a 12-channel, ECG Device used for the recording, analysis and evaluation of ECG recordings. Recordings made with the AT-10Plus can be used as a diagnostic aid for heart function and heart conditions. The AT-10Plus is designed for indoor use.
The device provide an optional interface to the SP-250 for pulmonary function data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050686: Cardiovit at-10PLUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050686
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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