# K021373: H12+Holter Recorder

- Pathway: 510(k) (Special)
- Applicant: Mortara Instrument, Inc.
- Decided: Jun 27, 2002 after 57 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911097 (1991). 1 ancestor in all.
11 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911097: PR4, Mortara Instrument, Inc. (1991) Summary page 1.

## Most influential descendants
- K043010: Holter Recorder H3+ (2005), 4 descendants of its own
- K151787: Holter System (2016), 2 descendants of its own
- K051730: Matrix Holter System, Model M12 (2005), 2 descendants of its own
- K101273: Dynamic Ecg System Model TLC5000 (2011), 1 descendant of its own
- K042782: Seer MC (2005), 1 descendant of its own

## Indications for use
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

Source page: https://510kreport.com/device/K021373
Methodology: https://510kreport.com/methodology