# K932724: Spacelabs Medical Integrated Clinical Display

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: Nov 5, 1993 after 151 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Oct 23, 2009 · Not classified · Z-0288-2011: The Spacelabs Medical Flat Panel Display, Model 94260-19 may fail prematurely and causing the screen to go blank. This inability to view data may result in delayed patient treatment.
- Mar 20, 2009 · Not classified · Z-0620-2011: The power supply of the Spacelabs Medical Flat Panel Display may fail, causing the display to go blank.
- Jan 7, 2005 · Not classified · Z-0422-05: Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients.
- Oct 29, 2003 · Not classified · Z-0269-04: Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail.

Source page: https://510kreport.com/device/K932724
Methodology: https://510kreport.com/methodology