510(k) · Cleared
ClearedH12+Holter Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortara Instrument, Inc. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Jun 27, 2002 as substantially equivalent to K911097 (Mortara Instrument, Inc., 1991) after a 57-day review. Its family tree reaches back 1 generation to 1991. 11 later devices descend from it.
- Decided
- Jun 27, 2002
- Review
- 57 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K911097 (1991). 11 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK911097 PR4Mortara Instrument, Inc. · 1991
- This deviceK021373 H12+Holter RecorderMortara Instrument, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK043010 Holter Recorder H3+Mortara Instrument, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK151787 Holter SystemEdan Instruments, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK051730 Matrix Holter System, Model M12Global Instrumentation, LLC · 2005
- Descendant · 2 generations on · 1 of its ownK101273 Dynamic Ecg System Model TLC5000Contec Medical System Co., Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK042782 Seer MCGe Medical Systems Information Technologies · 2005
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K043010Holter Recorder H3+Mortara Instrument, Inc. · 2005 · cites it directly4descendants
- K151787Holter SystemEdan Instruments, Inc. · 2016 · 2 generations on2descendants
- K051730Matrix Holter System, Model M12Global Instrumentation, LLC · 2005 · cites it directly2descendants
- K101273Dynamic Ecg System Model TLC5000Contec Medical System Co., Ltd. · 2011 · 2 generations on1descendant
- K042782Seer MCGe Medical Systems Information Technologies · 2005 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911097 | PR4 | Mortara Instrument, Inc. | 1991 | — |
| 0 (this device) | K021373 | H12+Holter Recorder | Mortara Instrument, Inc. | 2002 | — |
| +1 | K043010 | Holter Recorder H3+ | Mortara Instrument, Inc. | 2005 | — |
| +2 | K151787 | Holter System | Edan Instruments, Inc. | 2016 | — |
| +1 | K051730 | Matrix Holter System, Model M12 | Global Instrumentation, LLC | 2005 | — |
| +2 | K101273 | Dynamic Ecg System Model TLC5000 | Contec Medical System Co., Ltd. | 2011 | — |
| +1 | K042782 | Seer MC | Ge Medical Systems Information Technologies | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 4 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2026 | 2 | 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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 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 |
|---|---|---|---|
| * | K911097 | PR4Summary page 1…d devices to which S. E. is claimed The H12+ Holter Recorder is a modification of a legally marketed Mortara predicate device. 9 Mortara PR4 Holter Recorder (K9110977) Note: For commercial reasons, Mortara changed the proprietary name from PR 4 to H-12 in 1995 and has continued… | 1991 |
What descends from it? (11)
See all 114 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?
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
The H12+ Holter recorder is intended to acquire, record and store ECG data of patients that have been connected to the Mortara H12-1-recorder and are undergoing Holter monitoring. The H12+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter system. The H12+ performs no cardiac analysis by itself and is intended to be used with the H-Scribe Holter analysis system (K004017). ECG data prerecorded by the H12+ is acquired and analyzed by…
Read the full statement (237 words)
The H12+ Holter recorder is intended to acquire, record and store ECG data of patients that have been connected to the Mortara H12-1-recorder and are undergoing Holter monitoring. The H12+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter system. The H12+ performs no cardiac analysis by itself and is intended to be used with the H-Scribe Holter analysis system (K004017). ECG data prerecorded by the H12+ is acquired and analyzed by the H-Scribe. In turn the cardiac data and analysis provided by H-Scribe Holter system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
The H12+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of 24 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis. Holter analysis is appropriate for the indications below:
Evaluation of adult patients with symptoms suggesting arrhythmia or myocardial ischemia.
Evaluation of adult patients for ST segment changes
Evaluation of adult patients with pacemakers
Reporting of time domain heart rate variability
Evaluation of a patients response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)
Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients
Clinical and epidemiological research’studies
Infant patient evaluation is limited to QRS detection only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021373: H12+Holter Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021373
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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