# K011837: Lifecard CF 7 Day

- Pathway: 510(k) (Special)
- Applicant: Reynolds Medical, Ltd.
- Decided: Jul 13, 2001 after 31 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 K001025 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001025: Lifecard CF Compact Recorder, Reynolds Medical, Ltd. (2000) Summary page 1.

## Most influential descendants
- K212317: Eclipse MINI Model 98900 (2022), 0 descendants of its own
- K211651: Eclipse PRO (2021), 0 descendants of its own

## Indications for use
The Reynolds Lifecard CF 7-Day Holter recorder is a modification of the Reynolds Lifecard CF Holter Recorder, K001025. It is indicated when it is desired to record the patient’s ambulatory electrocardiogram. It is a portable Holter recorder designed to record the patient’s ambulatory electrocardiogram for up to seven days.

Source page: https://510kreport.com/device/K011837
Methodology: https://510kreport.com/methodology