510(k) · Cleared
ClearedCardiovit at-1C, at-2C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiller America, Inc. · LOS (no longer in FDA’s product-code list)
Cleared on Dec 19, 1995 after a 152-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.
- Decided
- Dec 19, 1995
- Review
- 152 days
- Product code
- LOS
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK953396 Cardiovit at-1C, at-2CSchiller America, Inc. · 1995
- Descendant · cites it directly · 9 of its ownK031557 Cardiovit at-102Schiller AG · 2004
- Descendant · 2 generations on · 5 of its ownK053207 Argus, Model LCMSchiller AG · 2006
- Descendant · 3 generations on · 4 of its ownK101619 Welch Allyn 1500 Patient MonitorSchiller AG · 2010
- Descendant · 4 generations on · 3 of its ownK133973 Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014
- Descendant · 5 generations on · 2 of its ownK170567 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K031557Cardiovit at-102Schiller AG · 2004 · cites it directly9descendants
- K053207Argus, Model LCMSchiller AG · 2006 · 2 generations on5descendants
- K101619Welch Allyn 1500 Patient MonitorSchiller AG · 2010 · 3 generations on4descendants
- K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014 · 4 generations on3descendants
- K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953396 | Cardiovit at-1C, at-2C | Schiller America, Inc. | 1995 | — |
| +1 | K031557 | Cardiovit at-102 | Schiller AG | 2004 | — |
| +2 | K053207 | Argus, Model LCM | Schiller AG | 2006 | — |
| +3 | K101619 | Welch Allyn 1500 Patient Monitor | Schiller AG | 2010 | — |
| +4 | K133973 | Tempus Pro with Enhanced Features | Remote Diagnostic Technologies, Ltd. | 2014 | — |
| +5 | K170567 | Tempus Pro Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LOS? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031557 | Cardiovit at-102 | 2004 | 9 |
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?
- Of its descendants, K031557 (Schiller AG, 2004) has gone furthest, with 9 descendants of its own.
https://510kreport.com/device/K953396 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953396: Cardiovit at-1C, at-2C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953396
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026