510(k) · Cleared
ClearedCardiovit at-102
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiller AG · DPS Electrocardiograph
Cleared on Apr 14, 2004 as substantially equivalent to K953396 (Schiller America, Inc., 1995) after a 331-day review. Its family tree reaches back 1 generation to 1995. 9 later devices descend from it.
- Decided
- Apr 14, 2004
- Review
- 331 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953396 (1995). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK953396 Cardiovit at-1C, at-2CSchiller America, Inc. · 1995
- This deviceK031557 Cardiovit at-102Schiller AG · 2004
- Descendant · cites it directly · 5 of its ownK053207 Argus, Model LCMSchiller AG · 2006
- Descendant · 2 generations on · 4 of its ownK101619 Welch Allyn 1500 Patient MonitorSchiller AG · 2010
- Descendant · 3 generations on · 3 of its ownK133973 Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014
- Descendant · 4 generations on · 2 of its ownK170567 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK050686 Cardiovit at-10PLUSSchiller AG · 2005
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K053207Argus, Model LCMSchiller AG · 2006 · cites it directly5descendants
- K101619Welch Allyn 1500 Patient MonitorSchiller AG · 2010 · 2 generations on4descendants
- K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014 · 3 generations on3descendants
- K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017 · 4 generations on2descendants
- K050686Cardiovit at-10PLUSSchiller AG · 2005 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953396 | Cardiovit at-1C, at-2C | Schiller America, Inc. | 1995 | — |
| 0 (this device) | K031557 | Cardiovit at-102 | Schiller AG | 2004 | — |
| +1 | K053207 | Argus, Model LCM | Schiller AG | 2006 | — |
| +2 | K101619 | Welch Allyn 1500 Patient Monitor | Schiller AG | 2010 | — |
| +3 | K133973 | Tempus Pro with Enhanced Features | Remote Diagnostic Technologies, Ltd. | 2014 | — |
| +4 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | — |
| +1 | K050686 | Cardiovit at-10PLUS | Schiller AG | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K953396 | Cardiovit at-1C, at-2CSummary page 1…Class 11 5. Reason for Premarket Notification: New Device 6. Substantially Equivalent Devices: CARDIOVIT AT-1C K953396 7. Substantial Equivalence: For all technical specifications, substantial… | 1995 |
What descends from it? (9)
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?
- Its one ancestor has no recall.
- Of its descendants, K053207 (Schiller AG, 2006) has gone furthest, with 5 descendants of its own.
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-102 is a 12-channel, ECG Device used for the recording, analysis and evaluation of ECG recordings. Recordings made with the AT-102 can be used as a diagnostic aid for heart function and heart conditions. The AT-102 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/K031557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031557: Cardiovit at-102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031557
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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