510(k) · Cleared
ClearedHolter Recorder H3+
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 Feb 25, 2005 as substantially equivalent to K021373 (Mortara Instrument, Inc., 2002) and 2 other predicates after a 116-day review. Its family tree reaches back 4 generations to 1987. 4 later devices descend from it.
- Decided
- Feb 25, 2005
- Review
- 116 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K871344 (1987). 16 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK871344 Pathfinder 3, Auto Surveyor and SurveyorReynolds Medical, Ltd. · 1987
- 3 generations backK951902 Pathfinder 700 Holter AnalyzerReynolds Medical, Ltd. · 1996 · Recalled
- 2 generations backK990727 Syneflash & SyneviewEla Medical, Inc. · 1999
- 1 generation backK032466 SpiderviewEla Medical, Inc. · 2003
- This deviceK043010 Holter Recorder H3+Mortara Instrument, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK151787 Holter SystemEdan Instruments, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK254119 Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251591 Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK152626 H3+ Holter RecorderMortara Instrument, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K151787Holter SystemEdan Instruments, Inc. · 2016 · cites it directly2descendants
- K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026 · 2 generations on0descendants
- K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026 · 2 generations on0descendants
- K152626H3+ Holter RecorderMortara Instrument, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871344 | Pathfinder 3, Auto Surveyor and Surveyor | Reynolds Medical, Ltd. | 1987 | — |
| −3 | K951902 | Pathfinder 700 Holter Analyzer | Reynolds Medical, Ltd. | 1996 | 1 |
| −2 | K990727 | Syneflash & Syneview | Ela Medical, Inc. | 1999 | — |
| −1 | K032466 | Spiderview | Ela Medical, Inc. | 2003 | — |
| 0 (this device) | K043010 | Holter Recorder H3+ | Mortara Instrument, Inc. | 2005 | — |
| +1 | K151787 | Holter System | Edan Instruments, Inc. | 2016 | — |
| +2 | K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart… | Shenzhen Xinyan Medical Technology Co.,ltd. | 2026 | — |
| +2 | K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026 | — |
| +1 | K152626 | H3+ Holter Recorder | Mortara Instrument, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K021373 | H12+Holter RecorderSummary page 1…ion to the Mortars Holter Recorder family and is substantially equivalent to the following legally marketed predicate devices: *Mortars H12+ Halter Recorder (K(021373) *Ela Medical Spiderview (K(032466) *Braemer I Phillips Digitrack Plus (1(993617) Description: The H3+ Holte… | 2002 |
| * | K032466 | SpiderviewSummary page 1…is substantially equivalent to the following legally marketed predicate devices: *Mortars H12+ Halter Recorder (K(021373) *Ela Medical Spiderview (K(032466) *Braemer I Phillips Digitrack Plus (1(993617) Description: The H3+ Holter Recorder is intended for use as part of a H… | 2003 |
| * | K993617 | Digitrakplus Holter RecorderSummary page 1…rketed predicate devices: *Mortars H12+ Halter Recorder (K(021373) *Ela Medical Spiderview (K(032466) *Braemer I Phillips Digitrack Plus (1(993617) Description: The H3+ Holter Recorder is intended for use as part of a Halter Analysis system and is designed to be used in conj… | 1999 |
What descends from it? (4)
2 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K151787 (Edan Instruments, Inc., 2016) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K021373.
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 H3+ Holter recorder is intended to acquire, record and store ECG data of patients that have been connected to the Mortara H3+ recorder and are undergoing Holter monitoring. The H3+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter analysis system. The H3+ 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 H3+ is acquired and analyzed…
Read the full statement (239 words)
The H3+ Holter recorder is intended to acquire, record and store ECG data of patients that have been connected to the Mortara H3+ recorder and are undergoing Holter monitoring. The H3+ acquires, digitizes and stores data to be analyzed by the H-Scribe Holter analysis system. The H3+ 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 H3+ is acquired and analyzed by the H-Scribe. In turn, the cardiac data and analysis provided by H-Scribe Holter analysis system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
The H3+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of up to 48 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
* 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 MI. 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/K043010 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043010: Holter Recorder H3+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043010
Report an extraction error
Are you the manufacturer?
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