# K211651: Eclipse PRO

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Healthcare, Ltd.
- Decided: Nov 22, 2021 after 178 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-0684-2025: 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 Spacelabs Model 98700 is a portable non-invasive Holter recorder intended to record the patient’s ambulatory electrocardiogram. The device is intended to be used by either pediatric or adult patients in either a clinical setting or at home. The device does no cardiac analysis and is used with a Holter Analysis System.

Source page: https://510kreport.com/device/K211651
Methodology: https://510kreport.com/methodology