510(k) · Cleared
Recalled · Class II · 2024H-Scribe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mortara Instrument, Inc. · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Jun 11, 2001 as substantially equivalent to K900607 (Cardiodata Corp., 1990) and 1 other predicate after a 166-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 11, 2001
- Review
- 166 days
- Class
- Class II
- Product code
- MLO
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K930806 (1994). 3 ancestors in all, the oldest K900607 (1990). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 1 generation backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- This deviceK004017 H-ScribeMortara Instrument, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK042002 Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK193177 CER-SCardiocalm · 2020
- Descendant · 3 generations on · 1 of its ownK213861 CER-SCardiocalm Srl · 2022
- Descendant · 4 generations on · 0 of its ownK243312 CER-SCardiocalm Srl · 2025
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −1 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| 0 (this device) | K004017 | H-Scribe | Mortara Instrument, Inc. | 2001 | — |
| +1 | K042002 | Synescope, Easyscope, Synecom, Holterreader | Ela Medical, Inc. | 2004 | — |
| +2 | K193177 | CER-S | Cardiocalm | 2020 | — |
| +3 | K213861 | CER-S | Cardiocalm Srl | 2022 | — |
| +4 | K243312 | CER-S | Cardiocalm Srl | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 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 MLO? 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 MLO device
- #1 K261580 ZBPro Diagnostic (Version 2.0)score 13.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K900607 | MK5 Detector & Alarm, Arrhythmia W/Software 2.11Summary page 1…mmable Diagnostic Computer (Per 21 CFR 870.1425) Legally marketed devices to which S.E. is claimed Cardiodata MK5 Holter Analysis System - 51O(k) K900607 Zymed Holter Scanner, Model 2010 Plus - 51O(k) K 955015 Description: The H-Scribe Holter Analysis system… | 1990 |
| * | K955015 | Zymed Holter Scanner Model 2010Summary page 1…which S.E. is claimed Cardiodata MK5 Holter Analysis System - 51O(k) K900607 Zymed Holter Scanner, Model 2010 Plus - 51O(k) K 955015 Description: The H-Scribe Holter Analysis system is a PC based diagnostic tool consisting of a Holter analysis software applica… | 1996 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042002 | Synescope, Easyscope, Synecom, Holterreader | 2004 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2024 | Class II | Z-0320-2025 | Software design | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this… |
| Oct 11, 2024 | Class II | Z-0323-2025 | Software design | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K042002 (Ela Medical, Inc., 2004) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MLO devicesMLO Electrocardiograph, Ambulatory, With Analysis Algorithm: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MLO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLO
238in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLO
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLO
4in 2025
MAUDE reports naming product code MLO, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 3 | 238 | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 2 | 2 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The H-Scribe Holter system is intended to acquire, automatically analyze, edit, review, report and store prerecorded ECG data of patients that have been connected to the Mortara H-12 digital recorder or to other compatible tape or digital recorders. The cardiac data and analysis provided by H-Scribe Holter system is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various cardiac rhythm patterns. The H-Scribe…
Read the full statement (172 words)
The H-Scribe Holter system is intended to acquire, automatically analyze, edit, review, report and store prerecorded ECG data of patients that have been connected to the Mortara H-12 digital recorder or to other compatible tape or digital recorders. The cardiac data and analysis provided by H-Scribe Holter system is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various cardiac rhythm patterns.
The H-Scribe Holter system,is indicated for use in a clinical setting, by qualified medical professionals only, for patients requiring ambulatory (Holter) monitoring of 24 - 48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis. The analysis software package includes, among others, detection and reporting features appropriate to the indications below:
Evaluation of adult patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmia
Evaluation of adult patients for ST segment changes
Evaluation of adult patients with pacemakers
Reporting of time domain heart rate variability
Evaluation of infant patients limited to QRS detection only
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/K004017 · printed Nov 4, 2026
Cite this page
510(k) Report. “K004017: H-Scribe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K004017
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026