510(k) Report

510(k) · Cleared

Cleared

Cardiovit CS-200

K970879510(k) TraditionalCleared Jun 25, 1997107-day review

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Schiller America, Inc. · LOS (no longer in FDA’s product-code list)

Cleared on Jun 25, 1997 after a 107-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 12 later devices descend from it.

Decided
Jun 25, 1997
Review
107 days
Product code
LOS
Recalls
None
Predicates
0

12 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2013: 1 descendant cleared2004: 1 descendant cleared2023: 1 descendant cleared2006: 1 descendant cleared2010: 1 descendant cleared2017: 2 descendants cleared2014: 1 descendant cleared2018: 2 descendants cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK970879 Cardiovit CS-200Schiller America, Inc. · 1997
  2. Descendant · cites it directly · 11 of its ownK012226 Monitoring System,Model Argus PB-1000Schiller AG · 2002
  3. Descendant · 2 generations on · 5 of its ownK053207 Argus, Model LCMSchiller AG · 2006
  4. Descendant · 3 generations on · 4 of its ownK101619 Welch Allyn 1500 Patient MonitorSchiller AG · 2010
  5. Descendant · 4 generations on · 3 of its ownK133973 Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd. · 2014
  6. Descendant · 5 generations on · 2 of its ownK170567 Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd. · 2017

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12006: 12010: 12013: 12014: 12017: 22018: 22020: 12023: 1
2002high 2 (2017) · low 0 (2003)2026

Most influential descendants

Showing 5 of 12 · See all
  • K012226Monitoring System,Model Argus PB-1000Schiller AG · 2002 · cites it directly11descendants
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K970879Cardiovit CS-200Schiller America, Inc.1997—
+1K012226Monitoring System,Model Argus PB-1000Schiller AG2002—
+2K053207Argus, Model LCMSchiller AG2006—
+3K101619Welch Allyn 1500 Patient MonitorSchiller AG2010—
+4K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.2014—
+5K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200610
201010
201310
201410
201720
201820
202010
202310
FIG. 1 — Lineage of K970879, 1997–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (12)

See all 12

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012226Monitoring System,Model Argus PB-1000Schiller AG200211

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, K012226 (Schiller AG, 2002) has gone furthest, with 11 descendants of its own.

What is it indicated for?

The Cardiovit CS-200 device maybe used to record and store standard 12 lead Electrocardiograms (ECG) at patients resting or exercising. Resting ECG's are automatically measured and interpreted by the optionally available Schiller BCG interpretation program.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Schiller America, Inc.

10 FDA decisions under this applicant name. See the company

  • K973735Microvit MT-100Schiller America, Inc. · 1998
  • K973751MT-200Schiller America, Inc. · 1998
  • K953396Cardiovit at-1C, at-2CSchiller America, Inc. · 1995
  • K954066Miniscope MS-3Schiller America, Inc. · 1995
  • K941462Cardiovit at-5CSchiller America, Inc. · 1995

Recent decisions in LOS

The LOS category page

  • K090895Ekg-Plus II SoftwareBionet Co., Ltd. · 2009
  • K083749CARDIOVIEW32 Review ModuleQrs Diagnostic, LLC · 2009
  • K073376Philips Ecg AlgorithmPhilips Medical Systems · 2008
  • K023034Cardiotouch-3000Bionet Company, Ltd. · 2002
  • K011328Cardio Care Ekg-2000 12-Channel ElectrocardiographBionet Company, Ltd. · 2001

https://510kreport.com/device/K970879 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970879: Cardiovit CS-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970879

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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