# K110779: Spacelabs Smart Disclosure System

- Pathway: 510(k) (Special)
- Applicant: Spacelabs Healthcare
- Decided: Apr 19, 2011 after 29 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K844940 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063490: Spacelabs Medical Full Disclosure System, Model 91810, Spacelabs Medical, Inc. (2007) Summary page 1.

## Recalls of this device
- Jan 28, 2019 · Class II · Z-2035-2019: Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
- Feb 14, 2014 · Class II · Z-1273-2014: Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed on the Clinical Access CD are incorrect and it will prevent the customer from installing Clinical Acces
- Dec 5, 2012 · Class II · Z-0694-2013: Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the Spacelabs Healthcare Intesys Clinical Suite (ICS) G2, Version 4.03, Clinical Access portion of 

## Indications for use
The Spacelabs Smart Disclosure System, Model 92810 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. Smart Disclosure 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 Smart Disclosure is to interface with the Spacelabs monitoring network, providing the user with a means of recalling waveform information and performing retrospective analysis. The most recent 72 hours of monitored patient ECG waveform data can be analyzed, with each analysis limited to 24 hours or less.

Source page: https://510kreport.com/device/K110779
Methodology: https://510kreport.com/methodology