# K004017: H-Scribe

- Pathway: 510(k) (Traditional)
- Applicant: Mortara Instrument, Inc.
- Decided: Jun 11, 2001 after 166 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930806 (1994). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900607: MK5 Detector & Alarm, Arrhythmia W/Software 2.11, Cardiodata Corp. (1990) Summary page 1.
- K955015: Zymed Holter Scanner Model 2010, Zymed Medical Instrumentation (1996) Summary page 1.

## Most influential descendants
- K042002: Synescope, Easyscope, Synecom, Holterreader (2004), 3 descendants of its own
- K193177: CER-S (2020), 2 descendants of its own
- K213861: CER-S (2022), 1 descendant of its own
- K243312: CER-S (2025), 0 descendants of its own

## Recalls of this device
- Oct 11, 2024 · Class II · Z-0320-2025: 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 solel
- Oct 11, 2024 · Class II · Z-0323-2025: 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 solel

## Indications for use
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

Source page: https://510kreport.com/device/K004017
Methodology: https://510kreport.com/methodology