# K063490: Spacelabs Medical Full Disclosure System, Model 91810

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: Mar 15, 2007 after 118 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- 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 K844940 (1985). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962930: Spacelabs Medical Ecg Analysis System, Spacelabs Medical, Inc. (1997) Summary page 3.

## Most influential descendants
- K110779: Spacelabs Smart Disclosure System (2011), 0 descendants of its own

## Recalls of this device
- Oct 17, 2008 · Not classified · Z-2270-2010: Potential for device to print out the wrong waveform data for the time indicated in the printout or display.

## Indications for use
The Spacelabs Medical Full Disclosure System is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. The Full Disclosure System is also indicated in those situations where a retrospective analysis of monitoring patients' ECG waveform data, that can be annotated and edited, is desired The intended use of the Spacelabs Medical Full Disclosure System is to interface with the Spacelabs monitoring network in order to provide the user with a means of recalling waveform information and retrospectively analyzing up to 72 hours of monitoring patient's most recent ECG waveform data.

Source page: https://510kreport.com/device/K063490
Methodology: https://510kreport.com/methodology