510(k) · Cleared
ClearedMicrovit MT-100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schiller America, Inc. · DSH Recorder, Magnetic Tape, Medical
Cleared on Aug 25, 1998 after a 329-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Aug 25, 1998
- Review
- 329 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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 DSH? 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 DSH device
- #1 K260157 LifeLens Physiological Monitorscore 18.0 · 22 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K745130 | Braemar DL 700 Holter Monitor Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
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.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The ECG Holter device, MICROVIT MT-100, is a recording device used to record long term Electrocardiographs for the diagnostics of symptomatic and asymptomatic arrhythmias, i.e. bradycardia, tachycardia, dfagnostic of arrhythmias in patients with coronary artery disease, in patients after reanimation, in patients with different diseases such as cardio- myopathy, high blood pressure, long QT syndrome. A Holter ECG recording is also used for clarifying…
Read the full statement (104 words)
The ECG Holter device, MICROVIT MT-100, is a recording device used to
record long term Electrocardiographs for the diagnostics of symptomatic
and asymptomatic arrhythmias, i.e. bradycardia, tachycardia, dfagnostic
of arrhythmias in patients with coronary artery disease, in patients
after reanimation, in patients with different diseases such as cardio-
myopathy, 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 {schemias.
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/K973735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973735: Microvit MT-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973735
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026