ClearanceBrief
Company ยท US

Spacelabs Healthcare, Llc

FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2022. Name variants (Inc, Corp, punctuation) are merged.

20510(k) clearances (0 in 12 months)
75recalls (3 in 12 months)
74recalls that name a 510(k)

Product codes

CodeDeviceRecords
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)37
DSIDetector And Alarm, Arrhythmia17
DQKComputer, Diagnostic, Programmable12
DXJDisplay, Cathode-Ray Tube, Medical5
CBKVentilator, Continuous, Facility Use4
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)4
MWJElectrocardiograph, Ambulatory (Without Analysis)4
BSZGas-Machine, Anesthesia3
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase2
DXNSystem, Measurement, Blood-Pressure, Non-Invasive2
DPSElectrocardiograph1
DQAOximeter1
DXHTransmitters And Receivers, Electrocardiograph, Telephone1
MHZStimulator, Vestibular Acceleration, Therapeutic1
MSXSystem, Network And Communication, Physiological Monitors1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Nov 7, 2022K212317Eclipse MINI Model 98900
Spacelabs Healthcare, Ltd., GB
MWJ
Nov 22, 2021K211651Eclipse PRO
Spacelabs Healthcare, Ltd., GB
MWJ
Mar 26, 2021K201921Spacelabs Lifescreen PRO Analyzer
Spacelabs Healthcare, Ltd., GB
DQK
Apr 1, 2016K152881SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
Spacelabs Healthcare, Ltd., GB
DQK
Nov 5, 2015K150329elance Vital Signs Monitor, Central Monitor Software
Spacelabs Healthcare
MHX
Sep 26, 2014K141113SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE
Spacelabs Healthcare, Ltd.
DXN
Sep 9, 2014K141156SPACELABS HEALTHCARE TELEMETRY RECEIVER
Spacelabs Healthcare
MHX
Jul 23, 2013K130207SPACELABS HEALTHCARE CARDIOEXPRESS
Spacelabs Healthcare, Ltd.
DPS
Apr 22, 2013K122146XHIBIT CENTRAL STATION, MODEL 96102
Spacelabs Healthcare
MHX
Mar 21, 2013K130112CAPNO MODULE, 92517
Spacelabs Healthcare
CCK
Jul 13, 2012K121017CAPNOGRAPHY PAD (92516)
Spacelabs Healthcare
CCK
Jun 11, 2012K112729BLEASE700/900 SERIES VENTILATORS
Spacelabs Healthcare
CBK
Jun 6, 2012K121480ARIATELE TELEMETRY TRANSMITTER (96281)
Spacelabs Healthcare
MHX
Mar 22, 2012K113051SPACELABS ARKON ANESTHESIA WORKSTATION
Spacelabs Healthcare
CBK
Oct 5, 2011K112173SPEACELABS MULTIGAS MODULE
Spacelabs Healthcare
CBR
Jun 14, 2011K110001SPACELABS PATHFINDER SL HOLTER ANALYZER
Spacelabs Healthcare, Ltd.
DQK
Apr 19, 2011K110779SPACELABS SMART DISCLOSURE SYSTEM
Spacelabs Healthcare
DQK
Mar 3, 2011K103142SPACELABS MULTI-PARAMETER MODULE
Spacelabs Healthcare, Inc.
DSI
Mar 2, 2011K101850SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
Spacelabs Healthcare, Ltd.
CBK
Feb 4, 2011K103732SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR
Spacelabs Healthcare, Ltd.
DXN

Latest recalls

DateFirm and productCodeLinked 510(k)
Aug 7, 2026Spacelabs Healthcare, Inc.
Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A Product Description: The Spacelabs Healthcare (Spacelabs) Xhibit Central Station, Model 96102.
Open, Classified
MHXK122146
May 1, 2026Spacelabs Healthcare, Inc.
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the S
Open, Classified
DSIK103142
Apr 7, 2026Spacelabs Healthcare, Inc.
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
Open, Classified
DSIK103142
Oct 31, 2025Spacelabs Healthcare, Ltd.
Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentinel Cardi
Open, Classified
DQKK152881
Oct 16, 2025Spacelabs Healthcare, Inc.
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male disp
Open, Classified
MHXK112962
K120616
Oct 16, 2025Spacelabs Healthcare, Inc.
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male disp
Open, Classified
MHXK112962
K120616
Oct 16, 2025Spacelabs Healthcare, Inc.
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male displ
Open, Classified
MHXK112962
K120616
Jan 7, 2025Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Open, Classified
MHXK141156
Jan 7, 2025Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Open, Classified
MHXK141156
Dec 17, 2024Spacelabs Healthcare, Ltd.
Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.
Open, Classified
MWJK212317
Dec 17, 2024Spacelabs Healthcare, Ltd.
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
Open, Classified
MWJK211651
May 3, 2023Spacelabs Healthcare, Inc.
Ultraview SL (UVSL) Command Module, Model 91496
Open, Classified
DSIK103142
May 31, 2022Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver, Model: 96280
Open, Classified
MHXK141156
Nov 6, 2020Spacelabs Healthcare, Ltd.
Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
Terminated
DQKK152881
Aug 30, 2019Spacelabs Healthcare, Inc.
Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelab
Terminated
MHXK122146
Jan 28, 2019Spacelabs Healthcare, Inc.
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Terminated
DQKK110779
Aug 10, 2018Spacelabs Healthcare, Ltd.
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia
Terminated
CBKK113051
Jan 25, 2018Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Mod
Terminated
MSXK141156
Nov 21, 2017Spacelabs Healthcare, Ltd.
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment
Terminated
BSZK113051
Nov 2, 2016Spacelabs Healthcare Inc
Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthc
Terminated
MHXK122146
Sep 26, 2016Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
Terminated
MHXK141156
Sep 26, 2016Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
Terminated
MHXK122146
Aug 4, 2016Spacelabs Healthcare Inc
91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2
Terminated
DSIK103142
Mar 28, 2016Spacelabs Healthcare Inc
The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
Terminated
MHXK141156
Feb 26, 2016Spacelabs Healthcare Inc
Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient mo
Terminated
MHXK122146
Oct 30, 2015Spacelabs Healthcare Inc
Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short
Terminated
DXHK972649
May 13, 2015Spacelabs Healthcare Inc
Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports i
Terminated
MHXK120616
May 4, 2015Spacelabs Healthcare Inc
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acqu
Terminated
DSIK103142
Apr 28, 2015Spacelabs Healthcare Inc
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PC
Terminated
DSIK103142
Feb 24, 2015Spacelabs Healthcare Inc
Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated b
Terminated
MHXK120616
Feb 24, 2015Spacelabs Healthcare Inc
Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, an
Terminated
MHXK112962
Sep 25, 2014Spacelabs Healthcare Inc
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option
Terminated
MHXK102422
Sep 4, 2014Spacelabs Healthcare Inc
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
Terminated
MHXK121480
Jul 17, 2014Spacelabs Healthcare Inc
Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentrati
Terminated
CBRK112173
Jun 23, 2014Spacelabs Healthcare Inc
Spacelabs Healthcare Qube Compact Monitor, Model 91390. Intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors vi
Terminated
MHXK120616
Jun 18, 2014Spacelabs Healthcare Inc
Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
Terminated
DQAK903702
Jun 3, 2014Spacelabs Healthcare Inc
Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and
Terminated
DSIK103142
Mar 25, 2014Spacelabs Healthcare, Llc
Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers.
Terminated
DQKK110779
Jan 30, 2014Spacelabs Healthcare, Llc
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
Terminated
MHXK121480
Nov 18, 2013Spacelabs Healthcare, Llc
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed h
Terminated
MHXK120616
Nov 8, 2013Spacelabs Healthcare, Llc
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
Terminated
MHXK120616
Jan 17, 2013Spacelabs Healthcare, Llc
Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital
Terminated
DQKK110779
Nov 20, 2012Spacelabs Healthcare, Llc
qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD displa
Terminated
MHXK120616
Nov 5, 2012Spacelabs Healthcare, Llc
The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --
Terminated
MHXK112962
Sep 14, 2012Spacelabs Healthcare, Llc
Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter
Terminated
DSIK842616
Jul 16, 2012Spacelabs Healthcare, Llc
Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is
Terminated
MHXK112962
Jun 20, 2012Spacelabs Healthcare, Llc
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information coll
Terminated
DQKK110001
Jun 5, 2012Spacelabs Healthcare, Llc
Product is the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393. The Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parame
Terminated
MHXK112962
Jan 17, 2012Spacelabs Healthcare, Llc
Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process va
Terminated
DSIK103142
Jan 11, 2012Spacelabs Healthcare, Llc
Ultraview SL Command Module is the Spacelabs Multi-parameter Module. It is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters
Terminated
DSIK103142

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