510(k) · Cleared
ClearedMT-200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiller America, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Aug 25, 1998 as substantially equivalent to K914577 (Precision Health Care Systems, Inc., 1992) after a 328-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Aug 25, 1998
- Review
- 328 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914577 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK914577 Rhythmscan Precision 6000Precision Health Care Systems, Inc. · 1992
- This deviceK973751 MT-200Schiller America, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914577 | Rhythmscan Precision 6000 | Precision Health Care Systems, Inc. | 1992 | — |
| 0 (this device) | K973751 | MT-200 | Schiller America, Inc. | 1998 | — |
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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 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 |
|---|---|---|---|
| * | K914577 | Rhythmscan Precision 6000Summary page 1…Diagnostic Proororrwnoble Class 2 A3 legally Marketed Device Legally Marketed Device to which this submitted device Is ocmpc:ed Brentwood Rhythrnscan Pracision CS-6000 (K914577) L A4 Description of Submitted Device , The ECG Holfer evaluation software, MT-200, is an analysis 8 used for the analysis and… | 1992 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K914577.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The ECG Holter evaluation software, MT-200, is an analysis software used for the analysis and evaluation of Holter ECG recordings. The Holter recordings are used for. the diagnostics of symptomatic and asymptomatic arrhythmias, i.e. bradycardia, tachycardia, diagnostic of arrhythmias in patients with coronary artery disease, in patients after reanimation, in patients with different diseases such as cardiomyopathy, high blood pressure, long QT syndrome. A…
Read the full statement (111 words)
The ECG Holter evaluation software, MT-200, is an analysis software
used for the analysis and evaluation of Holter ECG recordings. The
Holter recordings are used for. the diagnostics of symptomatic and
asymptomatic arrhythmias, i.e. bradycardia, tachycardia, diagnostic
of arrhythmias in patients with coronary artery disease, in patients
after reanimation, in patients with different diseases such as
cardiomyopathy, high blood pressure, long QT syndrome.
A Holter ECG.recording is also used for clarifying palpitations or
syncopes and attacks of dizziness or for controlling medical therapies,
or after operative treatments such as bypass .operations or PTCA. The ST
segment analysis of a Holter ECG is used for the detection of symptomatic
or asymptomatic ischemias.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973751 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973751: MT-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973751
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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