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
| Code | Device | Records |
|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 37 |
| DSI | Detector And Alarm, Arrhythmia | 17 |
| DQK | Computer, Diagnostic, Programmable | 12 |
| DXJ | Display, Cathode-Ray Tube, Medical | 5 |
| CBK | Ventilator, Continuous, Facility Use | 4 |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | 4 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 4 |
| BSZ | Gas-Machine, Anesthesia | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 |
| DPS | Electrocardiograph | 1 |
| DQA | Oximeter | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 |
| MHZ | Stimulator, Vestibular Acceleration, Therapeutic | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 7, 2022 | K212317 | Eclipse MINI Model 98900 Spacelabs Healthcare, Ltd., GB | MWJ |
| Nov 22, 2021 | K211651 | Eclipse PRO Spacelabs Healthcare, Ltd., GB | MWJ |
| Mar 26, 2021 | K201921 | Spacelabs Lifescreen PRO Analyzer Spacelabs Healthcare, Ltd., GB | DQK |
| Apr 1, 2016 | K152881 | SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM Spacelabs Healthcare, Ltd., GB | DQK |
| Nov 5, 2015 | K150329 | elance Vital Signs Monitor, Central Monitor Software Spacelabs Healthcare | MHX |
| Sep 26, 2014 | K141113 | SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE Spacelabs Healthcare, Ltd. | DXN |
| Sep 9, 2014 | K141156 | SPACELABS HEALTHCARE TELEMETRY RECEIVER Spacelabs Healthcare | MHX |
| Jul 23, 2013 | K130207 | SPACELABS HEALTHCARE CARDIOEXPRESS Spacelabs Healthcare, Ltd. | DPS |
| Apr 22, 2013 | K122146 | XHIBIT CENTRAL STATION, MODEL 96102 Spacelabs Healthcare | MHX |
| Mar 21, 2013 | K130112 | CAPNO MODULE, 92517 Spacelabs Healthcare | CCK |
| Jul 13, 2012 | K121017 | CAPNOGRAPHY PAD (92516) Spacelabs Healthcare | CCK |
| Jun 11, 2012 | K112729 | BLEASE700/900 SERIES VENTILATORS Spacelabs Healthcare | CBK |
| Jun 6, 2012 | K121480 | ARIATELE TELEMETRY TRANSMITTER (96281) Spacelabs Healthcare | MHX |
| Mar 22, 2012 | K113051 | SPACELABS ARKON ANESTHESIA WORKSTATION Spacelabs Healthcare | CBK |
| Oct 5, 2011 | K112173 | SPEACELABS MULTIGAS MODULE Spacelabs Healthcare | CBR |
| Jun 14, 2011 | K110001 | SPACELABS PATHFINDER SL HOLTER ANALYZER Spacelabs Healthcare, Ltd. | DQK |
| Apr 19, 2011 | K110779 | SPACELABS SMART DISCLOSURE SYSTEM Spacelabs Healthcare | DQK |
| Mar 3, 2011 | K103142 | SPACELABS MULTI-PARAMETER MODULE Spacelabs Healthcare, Inc. | DSI |
| Mar 2, 2011 | K101850 | SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION Spacelabs Healthcare, Ltd. | CBK |
| Feb 4, 2011 | K103732 | SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR Spacelabs Healthcare, Ltd. | DXN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2026 | Spacelabs 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 |
MHX | K122146 |
| May 1, 2026 | Spacelabs 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 |
DSI | K103142 |
| Apr 7, 2026 | Spacelabs Healthcare, Inc. Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor Open, Classified |
DSI | K103142 |
| Oct 31, 2025 | Spacelabs 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 |
DQK | K152881 |
| Oct 16, 2025 | Spacelabs 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 |
MHX | K112962 K120616 |
| Oct 16, 2025 | Spacelabs 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 |
MHX | K112962 K120616 |
| Oct 16, 2025 | Spacelabs 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 |
MHX | K112962 K120616 |
| Jan 7, 2025 | Spacelabs Healthcare, Inc. Xhibit Telemetry Receiver, Model 96280, with Service Manual.
Intended to provide monitoring system with patient data. Open, Classified |
MHX | K141156 |
| Jan 7, 2025 | Spacelabs Healthcare, Inc. Xhibit Telemetry Receiver with Software, Model 96280.
Intended to provide monitoring system with patient data. Open, Classified |
MHX | K141156 |
| Dec 17, 2024 | Spacelabs 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 |
MWJ | K212317 |
| Dec 17, 2024 | Spacelabs 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 |
MWJ | K211651 |
| May 3, 2023 | Spacelabs Healthcare, Inc. Ultraview SL (UVSL) Command Module, Model 91496 Open, Classified |
DSI | K103142 |
| May 31, 2022 | Spacelabs Healthcare, Inc. Xhibit Telemetry Receiver, Model: 96280 Open, Classified |
MHX | K141156 |
| Nov 6, 2020 | Spacelabs 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 |
DQK | K152881 |
| Aug 30, 2019 | Spacelabs 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 |
MHX | K122146 |
| Jan 28, 2019 | Spacelabs Healthcare, Inc. Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2. Terminated |
DQK | K110779 |
| Aug 10, 2018 | Spacelabs 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 |
CBK | K113051 |
| Jan 25, 2018 | Spacelabs 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 |
MSX | K141156 |
| Nov 21, 2017 | Spacelabs 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 |
BSZ | K113051 |
| Nov 2, 2016 | Spacelabs 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 |
MHX | K122146 |
| Sep 26, 2016 | Spacelabs 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 |
MHX | K141156 |
| Sep 26, 2016 | Spacelabs 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 |
MHX | K122146 |
| Aug 4, 2016 | Spacelabs 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 |
DSI | K103142 |
| Mar 28, 2016 | Spacelabs 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 |
MHX | K141156 |
| Feb 26, 2016 | Spacelabs 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 |
MHX | K122146 |
| Oct 30, 2015 | Spacelabs 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 |
DXH | K972649 |
| May 13, 2015 | Spacelabs 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 |
MHX | K120616 |
| May 4, 2015 | Spacelabs 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 |
DSI | K103142 |
| Apr 28, 2015 | Spacelabs 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 |
DSI | K103142 |
| Feb 24, 2015 | Spacelabs 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 |
MHX | K120616 |
| Feb 24, 2015 | Spacelabs 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 |
MHX | K112962 |
| Sep 25, 2014 | Spacelabs 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 |
MHX | K102422 |
| Sep 4, 2014 | Spacelabs Healthcare Inc ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment. Terminated |
MHX | K121480 |
| Jul 17, 2014 | Spacelabs 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 |
CBR | K112173 |
| Jun 23, 2014 | Spacelabs 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 |
MHX | K120616 |
| Jun 18, 2014 | Spacelabs Healthcare Inc Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07 Terminated |
DQA | K903702 |
| Jun 3, 2014 | Spacelabs 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 |
DSI | K103142 |
| Mar 25, 2014 | Spacelabs 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 |
DQK | K110779 |
| Jan 30, 2014 | Spacelabs 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 |
MHX | K121480 |
| Nov 18, 2013 | Spacelabs 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 |
MHX | K120616 |
| Nov 8, 2013 | Spacelabs Healthcare, Llc Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms. Terminated |
MHX | K120616 |
| Jan 17, 2013 | Spacelabs 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 |
DQK | K110779 |
| Nov 20, 2012 | Spacelabs 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 |
MHX | K120616 |
| Nov 5, 2012 | Spacelabs 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 |
MHX | K112962 |
| Sep 14, 2012 | Spacelabs 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 |
DSI | K842616 |
| Jul 16, 2012 | Spacelabs 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 |
MHX | K112962 |
| Jun 20, 2012 | Spacelabs 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 |
DQK | K110001 |
| Jun 5, 2012 | Spacelabs 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 |
MHX | K112962 |
| Jan 17, 2012 | Spacelabs 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 |
DSI | K103142 |
| Jan 11, 2012 | Spacelabs 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 |
DSI | K103142 |
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