# K152626: H3+ Holter Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Mortara Instrument, Inc.
- Decided: Feb 26, 2016 after 164 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: 5 generations back to K871344 (1987). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043010: Holter Recorder H3+, Mortara Instrument, Inc. (2005) Summary page 4.

## Indications for use
The H3+ Holter recorder is intended to acquire, record and store continuous ECG data as directed by a clinician from adult, adolescent, pediatric, infant and neonate patient populations for a maximum recording time of 14 days in a hospital, clinic or home environment. The H3+ performs no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system which will analyze the recorded data. The H3+ data and the data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis. The H3+ Holter Recorder is not a life-supporting device.

Source page: https://510kreport.com/device/K152626
Methodology: https://510kreport.com/methodology