# K032276: Click Holter

- Pathway: 510(k) (Abbreviated)
- Applicant: Remco Italia S.P.A.
- Decided: Aug 27, 2003 after 35 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: 2 generations back to K950944 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993618: DXP1000 Holter Recorder, Braemar Corp. (1999) Summary page 1.

## Indications for use
The Click Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below: Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. Evaluation of ECG documenting therapeutic interventions in individual patients or group of patients. Evaluation of patient’s ST segment alterations. Patient follow up after M.I. or cardiac surgery. Clinical and epidemiological studies Pace maker evaluation Time or Frequency domain heart rate variability analysis Qt interval analysis

Source page: https://510kreport.com/device/K032276
Methodology: https://510kreport.com/methodology