Data / Medical devices / United Kingdom / Spacelabs Healthcare Ltd.
Spacelabs Healthcare Ltd.: FDA-registered device maker in HERTFORD Hertfordshire, United Kingdom, 18 510(k) clearances
Spacelabs Healthcare Ltd. is registered with the FDA (registration 9611295) in HERTFORD Hertfordshire, United Kingdom. It lists 10 device types. The FDA files 18 510(k) clearances under its listings, the newest dated November 7, 2022. 16 recall events name it as the recalling firm (5 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611295
- FEI number
- 3002807992
- Address
- Unit B, Foxholes Centre JOHN TATE ROAD, HERTFORD Hertfordshire, United Kingdom, SG13 7DT
- Owner or operator
- SPACELABS HEALTHCARE, INC. (2022906)
- Roles
- Specification developer
- First device listed
- January 8, 1998
- Registered through
- 2026
- Brand names listed
- 015-0721-00 Micro-V Alternans Sensor (MV4), Pouch of 7, 015-0722-00 Micro-V Alternans Sensor (MV4), Case of 20 pouches, 015-0724-00 Micro-V Alternans Sensor (MV4), Case of 5 pouches, 015-0725-00 Micro-V Alternans Sensor (MV4), Case of 1 pouch, 040-1747-00 PC, Configured, HearTwave II, 90200, 50-0018, 50-0034, 50-0035, 50-0044, 50-0045, 50-0169, 685-0260-00 PM-3 Patient Module, 700-0332-01 Micro-V Cable US and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Specification developer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Specification developer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 2 | Specification developer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Specification developer | accessdata.fda.gov |
| Gas-Machine, Anesthesia | BSZ | 2 | Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Specification developer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Specification developer | accessdata.fda.gov |
| Vaporizer, Anesthesia, Non-Heated | CAD | 2 | Specification developer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Specification developer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 7, 2022 | K212317 | Eclipse MINI Model 98900 | MWJ | Substantially Equivalent | Spacelabs Healthcare, Ltd. | accessdata.fda.gov |
| November 22, 2021 | K211651 | Eclipse PRO | MWJ | Substantially Equivalent | Spacelabs Healthcare, Ltd. | accessdata.fda.gov |
| March 26, 2021 | K201921 | Spacelabs Lifescreen PRO Analyzer | DQK | Substantially Equivalent | Spacelabs Healthcare, Ltd. | accessdata.fda.gov |
| April 1, 2016 | K152881 | SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM | DQK | Substantially Equivalent | Spacelabs Healthcare, Ltd. | accessdata.fda.gov |
| September 26, 2014 | K141113 | SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE | DXN | Substantially Equivalent | Spacelabs Healthcare, Ltd. | accessdata.fda.gov |
| July 23, 2013 | K130207 | SPACELABS HEALTHCARE CARDIOEXPRESS | DPS | Substantially Equivalent | Spacelabs Healthcare, Ltd. | accessdata.fda.gov |
| June 11, 2012 | K112729 | BLEASE700/900 SERIES VENTILATORS | CBK | Substantially Equivalent | Spacelabs Healthcare | accessdata.fda.gov |
| March 22, 2012 | K113051 | SPACELABS ARKON ANESTHESIA WORKSTATION | CBK | Substantially Equivalent | Spacelabs Healthcare | accessdata.fda.gov |
| June 14, 2011 | K110001 | SPACELABS PATHFINDER SL HOLTER ANALYZER | DQK | Substantially Equivalent | Spacelabs Healthcare, Ltd. | accessdata.fda.gov |
| March 2, 2011 | K101850 | SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION | CBK | Substantially Equivalent | Spacelabs Healthcare, Ltd. | accessdata.fda.gov |
| February 4, 2011 | K103732 | SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR | DXN | Substantially Equivalent | Spacelabs Healthcare, Ltd. | accessdata.fda.gov |
| April 7, 2005 | K050225 | HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM | DQK | Substantially Equivalent | Cambridge Heart, Inc. | accessdata.fda.gov |
| August 1, 2003 | K024283 | CARDIODIRECT, MODELS 12M, 12I, 12S | DPS | Substantially Equivalent | Reynolds Medical , Ltd. | accessdata.fda.gov |
| July 13, 2001 | K011837 | LIFECARD CF 7 DAY | MWJ | Substantially Equivalent | Reynolds Medical , Ltd. | accessdata.fda.gov |
| May 23, 2001 | K003251 | BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 | BSZ | Substantially Equivalent | Blease Medical Equipment , Ltd. | accessdata.fda.gov |
| August 9, 2000 | K001727 | MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES | BSZ | Substantially Equivalent | Blease Medical Equipment , Ltd. | accessdata.fda.gov |
| December 4, 1997 | K972649 | CARDIOCALL CARDIAC EVENT RECORDER | DXH | Substantially Equivalent | Reynolds Medical , Ltd. | accessdata.fda.gov |
| April 13, 1995 | K942799 | DATUM | CAD | Substantially Equivalent | Blease USA, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 16, 2025 | 97686 | Class II | Ongoing | 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 Cardiology Information Man | Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record | accessdata.fda.gov |
| November 25, 2024 | 95786 | Class II | Ongoing | Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram. | Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device. | accessdata.fda.gov |
| November 6, 2020 | 86753 | Class II | Terminated | Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use. | During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain comments at the time of the upgrade, may have unrelated comments added. Existing comments will not be overwritten or removed. Rhythm ECG Tests may have comments overwritten with unrelated comments. Any tests created after | accessdata.fda.gov |
| July 11, 2018 | 80462 | Class I | Terminated | 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 Workstation is intende | Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle. | accessdata.fda.gov |
| October 11, 2017 | 78330 | Class I | Terminated | 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 and operating room. I | Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted in a blank screen without audible or visible alarms. | accessdata.fda.gov |
| February 8, 2017 | 76429 | Class II | Terminated | Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the eve | Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting down without warning. The power supply has failed in a way that does not trigger the normal on battery alarms. | accessdata.fda.gov |
| March 5, 2015 | 70754 | Class II | Terminated | Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under gen | Reports of inaccurate low flow readings. Monitored inspiratory tidal volume (VTi) and expiratory tidal volume (Vte) measurements from the pediatric flow sensor are reporting out of specification low compared to the actual delivered volumes being administered to the patient. | accessdata.fda.gov |
| March 10, 2014 | 67781 | Class I | Terminated | SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator. | The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence. | accessdata.fda.gov |
| October 17, 2013 | 66721 | Class I | Terminated | CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits par | Spacelabs Healthcare Ltd. of United Kingdom recalls, and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber. | accessdata.fda.gov |
| June 7, 2013 | 65630 | Class II | Terminated | Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without th | Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error. | accessdata.fda.gov |
| January 15, 2013 | 64535 | Class I | Terminated | Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the | A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient. | accessdata.fda.gov |
| November 2, 2012 | 63714 | Class II | Terminated | BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the cus | The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematurely updated for a feature that is not yet available. | accessdata.fda.gov |
| November 11, 2011 | 60592 | Not yet classified | Terminated | Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31. Lifescreen Apnea is indicated for screening adults for the probability that they suffer from obstructive sleep apnea, mixed apnea or hypopnea, in order t | When Lifescreen is left open and a new recording is loaded from Sentinel Cardiology Information Management System, customers can get corruption in the data or a wrong ECG after the first 32 hours. Both recordings have to be longer than 32 hours for this to happen. | accessdata.fda.gov |
| October 12, 2011 | 60205 | Not yet classified | Terminated | PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads. Hook-up kits that contain th | The non-sterile alcohol prep pads (B339) are included in Spacelabs Healthcare hook-up kits may have the presence of a bacterium, Bacillus cereus. These alcohol prep pads were manufactured and recalled by Professional Disposables International (PDI). | accessdata.fda.gov |
| October 12, 2011 | 60204 | Not yet classified | Terminated | Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor is a small, lightweight unit designed to take blood pressure and heart rate measurements for a 24 | If external pressure is applied to the cuff of the Ambulatory Blood Pressure, Model 90217A, during deflation, the monitor will stop working and display an EC75 error code. | accessdata.fda.gov |
| September 10, 2010 | 60803 | Not yet classified | Terminated | Affected device is Model 98400-SL6-AHA, CardioExpress Electrocardiograph. The ECG cable part number is 01.57.471017. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and | CardioExpress SL6 ECG cable provided with the electrocardiograph is mislabeled. The left arm (LA) is mislabeled as right leg (RL). The left leg (LL) is mislabeled as left arm (LA). The right leg (RL) is mislabeled as left leg (LL). | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Computer, Diagnostic, Programmable
- All makers of Vaporizer, Anesthesia, Non-Heated
- All makers of Ventilator, Continuous, Facility Use
- All makers of Electrocardiograph
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
Updated October 31, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.