# Spacelabs Healthcare

- Location (FDA's records): Nederland, CO
- FDA decisions: 20 (2011–2022): 20 510(k) clearances
- Names in FDA's records: Spacelabs Healthcare (10); Spacelabs Healthcare, Ltd. (9); Spacelabs Healthcare, Inc. (1)
- Product codes: MHX (4), DQK (4), CBK (3), DXN (2), MWJ (2), CCK (2), CBR (1), DPS (1), DSI (1)
- 510(k) review time since 2016: median 259 days, against 190 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 26 (6 its own); citations of its devices by later devices: 9 (6 its own)
- Recalls linked to its devices: 45 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Spacelabs Medical, Inc.: 6 (https://510kreport.com/company/spacelabs-medical)
- Reynolds Medical, Ltd.: 3 (https://510kreport.com/company/reynolds-medical)
- Edan Instruments, Inc.: 2 (https://510kreport.com/company/edan-instruments)
- Del Mar Reynolds Medical, Ltd.: 2 (https://510kreport.com/company/del-mar-reynolds-medical)
- Blease USA, Inc.: 1 (https://510kreport.com/company/blease-usa)
- Ge Medical Systems Information Technologies: 1 (https://510kreport.com/company/ge-medical-systems-information-technologies)
- Del Mar Medical Systems, LLC: 1 (https://510kreport.com/company/del-mar-medical-systems)
- Spacelabs, Inc.: 1 (https://510kreport.com/company/spacelabs)

## Firms that cite its devices most
- Inovise Medical, Inc.: 2 (https://510kreport.com/company/inovise-medical)
- Anybattery, Inc.: 1 (https://510kreport.com/company/anybattery)

## Its most-cited devices
- K110001: Spacelabs Pathfinder SL Holter Analyzer (2011), cited by 3
- K101850: Spacelabs Bleasesirius Anesthesia Workstation (2011), cited by 2
- K112173: Speacelabs Multigas Module (2011), cited by 1
- K141156: Spacelabs Healthcare Telemetry Receiver (2014), cited by 1
- K121017: Capnography Pad (92516) (2012), cited by 1
- K103732: Spacelabs Model 90217A Ambulatory Blood Pressure (Abp) Monitor (2011), cited by 1

## Recent decisions
- K212317: Eclipse MINI Model 98900 (Nov 7, 2022)
- K211651: Eclipse PRO (Nov 22, 2021)
- K201921: Spacelabs Lifescreen PRO Analyzer (Mar 26, 2021)
- K152881: Sentinel Cardiology Information Management System (Apr 1, 2016)
- K150329: elance Vital Signs Monitor, Central Monitor Software (Nov 5, 2015)
- K141113: Spacelbs Model on Trak (90227) Ambulatory Bloody Pressure (Abp) Non-Invasive (Sep 26, 2014)
- K141156: Spacelabs Healthcare Telemetry Receiver (Sep 9, 2014)
- K130207: Spacelabs Healthcare Cardioexpress (Jul 23, 2013)

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