# K043010: Holter Recorder H3+

- Pathway: 510(k) (Abbreviated)
- Applicant: Mortara Instrument, Inc.
- Decided: Feb 25, 2005 after 116 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: 4 generations back to K871344 (1987). 16 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021373: H12+Holter Recorder, Mortara Instrument, Inc. (2002) Summary page 1.
- K032466: Spiderview, Ela Medical, Inc. (2003) Summary page 1.
- K993617: Digitrakplus Holter Recorder, Braemar Corp. (1999) Summary page 1.

## Most influential descendants
- K151787: Holter System (2016), 2 descendants of its own
- K254119: Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) (2026), 0 descendants of its own
- K251591: Holter ECG and ABP system (HolterABP) (2026), 0 descendants of its own
- K152626: H3+ Holter Recorder (2016), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K043010
Methodology: https://510kreport.com/methodology