# K212317: Eclipse MINI Model 98900

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Healthcare, Ltd.
- Decided: Nov 7, 2022 after 469 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001025 (2000). 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)
- K011837: Lifecard CF 7 Day, Reynolds Medical, Ltd. (2001) Summary page 4.

## Recalls of this device
- Nov 25, 2024 · Class II · Z-0685-2025: Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number pr

## Indications for use
The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient’s electrocardiogram. The recorder is intended to be used by either paediatric or adult patients suspected of cardiac arrhythmias in either a clinical setting or at home. The recorder does no cardiac analysis and is used with Spacelabs Ambulatory ECG Analysis Software.

Source page: https://510kreport.com/device/K212317
Methodology: https://510kreport.com/methodology