# Spacelabs, Inc.

- Location (FDA's records): Redmond, WA
- FDA decisions: 46 (1976–1996): 46 510(k) clearances
- Product codes: DSI (11), DQA (4), DXN (3), DSH (3), DPS (3), DRT (2), FLL (2), LDD (2), LOS (2), CCK (2), DQK (2), DSK (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 22 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Spacelabs Medical, Inc.: 5 (https://510kreport.com/company/spacelabs-medical)
- Canamet Canadian Natl Medical Technologies, Inc.: 2 (https://510kreport.com/company/canamet-canadian-natl-medical-technologies)
- Puritan Bennett Corp.: 2 (https://510kreport.com/company/puritan-bennett)
- Data Critical Corp.: 2 (https://510kreport.com/company/data-critical)
- Datex-Ohmeda, Inc.: 2 (https://510kreport.com/company/datex-ohmeda)
- Qmed, Inc.: 1 (https://510kreport.com/company/qmed)
- General Electric Medical Systems Information Techn: 1 (https://510kreport.com/company/general-electric-medical-systems-information-techn)
- Healthstats International Pte., Ltd.: 1 (https://510kreport.com/company/healthstats-international)

## Its most-cited devices
- K855127: Ambulatory Blood Pressure Monitor Spacelabs #90202 (1986), cited by 6
- K950779: Heart Rate Variability Software Option (1995), cited by 3
- K903702: Model 90421 Flexport Interface (1990), cited by 2
- K913038: Spacelab Model 90845 PCMS Multidisclosure Station (1991), cited by 2
- K954962: Spacelabs Medical Multigas Analyzer (1996), cited by 2
- K842616: Spacelabs Alpha PC Patient Computer (1984), cited by 2

## Recent decisions
- K954962: Spacelabs Medical Multigas Analyzer (May 31, 1996)
- K951605: Spacelabs Medical Casemaster Information Management System (Jul 14, 1995)
- K950779: Heart Rate Variability Software Option (Apr 25, 1995)
- K941165: Comet Capnograph Module (Oct 6, 1994)
- K923788: Space Labs Model 90560 (Dec 6, 1993)
- K912742: Esophageal Stethoscope Temperature Probe (Apr 20, 1992)
- K913038: Spacelab Model 90845 PCMS Multidisclosure Station (Oct 4, 1991)
- K905065: Defibrillator Lead Adapter (Apr 12, 1991)

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