# Spacelabs Medical, Inc.

- Location (FDA's records): Redmond, WA
- FDA decisions: 35 (1993–2012): 35 510(k) clearances
- Product codes: DSI (13), MHX (7), MSX (2), DXJ (2), DQK (2), OLW (2), BSZ (2), GWQ (1), CBR (1), HGM (1), DQA (1), DXN (1)
- Predicates its devices cite: 56 (23 its own); citations of its devices by later devices: 51 (23 its own)
- Recalls linked to its devices: 37 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Spacelabs, Inc.: 5 (https://510kreport.com/company/spacelabs)
- Hewlett-Packard Co.: 3 (https://510kreport.com/company/hewlett-packard)
- Marquette Electronics, Inc.: 2 (https://510kreport.com/company/marquette-electronics)
- Agilent Technologies, Inc.: 2 (https://510kreport.com/company/agilent-technologies)
- Nellcor, Inc.: 2 (https://510kreport.com/company/nellcor)
- Respironics Novametrix, Inc.: 2 (https://510kreport.com/company/respironics-novametrix)
- Data Critical Corp.: 1 (https://510kreport.com/company/data-critical)
- Spacelabs Burdick, Inc.: 1 (https://510kreport.com/company/spacelabs-burdick)

## Firms that cite its devices most
- Spacelabs Healthcare: 6 (https://510kreport.com/company/spacelabs-healthcare)
- Datascope Corp.: 4 (https://510kreport.com/company/datascope)
- Anybattery, Inc.: 2 (https://510kreport.com/company/anybattery)
- Mediana Co., Ltd.: 2 (https://510kreport.com/company/mediana)
- Canamet Canadian Natl Medical Technologies, Inc.: 1 (https://510kreport.com/company/canamet-canadian-natl-medical-technologies)
- Ascom (Us), Inc.: 1 (https://510kreport.com/company/ascom-us)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Lms Medical Systems, Ltd.: 1 (https://510kreport.com/company/lms-medical-systems)

## Its most-cited devices
- K972502: Spacelabs Medical Integrated Multiparameter Module 90496 (1998), cited by 6
- K925510: Model 90478 & 90479 Telemetry Rec. Module&Housing (1994), cited by 5
- K102422: Spacelabs Medical Patient Monitors (2010), cited by 3
- K983996: Spacelabs Medical Ultraview Digital Telemtry System (1999), cited by 3
- K972282: Spacelabs Medical Pcis Patient Monitors (1997), cited by 3
- K062095: Mcare 300 Vital Signs Monitor, Model 91220 (2006), cited by 3

## Recent decisions
- K120616: Spacelabs Healthcare Qube Compact Monitor (91390 (Mar 29, 2012)
- K112962: Spacelabs Healthcare Xprezzon Beside Monitor (9913930) (Nov 2, 2011)
- K102422: Spacelabs Medical Patient Monitors (Dec 7, 2010)
- K093501: Elance Vital Signs Monitor and Elance Central Station (Nov 24, 2009)
- K082045: Modification to Mcare 300 Vital Signs Monitor, Model 91220 (Aug 1, 2008)
- K063490: Spacelabs Medical Full Disclosure System, Model 91810 (Mar 15, 2007)
- K062095: Mcare 300 Vital Signs Monitor, Model 91220 (Sep 29, 2006)
- K062278: Spacelabs Medical Clinical Event Interface, Model 91847 (Sep 19, 2006)

Source page: https://510kreport.com/company/spacelabs-medical