510(k) · Cleared
Recalled · Class I · 2018Spacelabs Arkon Anesthesia Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Healthcare · CBK Ventilator, Continuous, Facility Use
Cleared on Mar 22, 2012 as substantially equivalent to K101850 (Spacelabs Healthcare, Ltd., 2011) after a 161-day review. Its family tree reaches back 4 generations to 1999. 3 of the 6 devices in its family, counting itself, have a Class I recall. It has been recalled 6 times, including 3 Class I recalls.
- Decided
- Mar 22, 2012
- Review
- 161 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 6 (3 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to K982132 (1999). 5 ancestors in all. No later device cites it as a predicate yet. 3 of the 6 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK982132 Blease 6200 Anaesthesia VentilatorBlease Medical Equipment, Ltd. · 1999 · Recalled
- 3 generations backK041430 Blease Sirius Anesthesia System, Models 3000 and 2000Blease Medical Equipment, Ltd. · 2004
- 2 generations backK051629 Bleas Esiriuc Anaesthsia System, Models 3000, 2000Blease USA, Inc. · 2005 · Recalled
- 1 generation backK101850 Spacelabs Bleasesirius Anesthesia WorkstationSpacelabs Healthcare, Ltd. · 2011 · Recalled (Class I)
- This deviceK113051 Spacelabs Arkon Anesthesia WorkstationSpacelabs Healthcare · 2012
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982132 | Blease 6200 Anaesthesia Ventilator | Blease Medical Equipment, Ltd. | 1999 | 1 |
| −3 | K041430 | Blease Sirius Anesthesia System, Models 3000 and 2000 | Blease Medical Equipment, Ltd. | 2004 | — |
| −2 | K051629 | Bleas Esiriuc Anaesthsia System, Models 3000, 2000 | Blease USA, Inc. | 2005 | 3 |
| −1 | K101850 | Spacelabs Bleasesirius Anesthesia Workstation | Spacelabs Healthcare, Ltd. | 2011 | Class I |
| 0 (this device) | K113051 | Spacelabs Arkon Anesthesia Workstation | Spacelabs Healthcare | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101850 | Spacelabs Bleasesirius Anesthesia WorkstationSummary page 2…edicate Predicate Equivalent Devices: 510(k) Number ManufacturerI Model Spacelabs Arkon K10 1850 Spacelabs BleaseSirius Anesthesia Workstation IAnesthesia Workstation Devic… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 11, 2018 | Class I | Z-2589-2018 | Nonconforming Material/Component | Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle. |
| Oct 11, 2017 | Class I | Z-0072-2018 | Software design | 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… |
| Apr 14, 2017 | Class II | Z-2093-2017 | Device Design | Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient. |
| Feb 8, 2017 | Class II | Z-1460-2017 | Software design | 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. |
| Mar 10, 2014 | Class I | Z-1442-2014 | Software in the Use Environment | The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence. |
| Jun 7, 2013 | Class II | Z-1771-2013 | Software design | 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… |
The 5 latest of 6 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K101850Spacelabs Bleasesirius Anesthesia WorkstationSpacelabs Healthcare, Ltd. · 2011 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K003251Blease Frontline Plus Range, Anesthesia Machines, Model 440, 560 and 690Blease Medical Equipment, Ltd. · 2001 · 4 generations back · ◆ in the 2001 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 4 of the 5 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K101850.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.
The device is intended for use only by a suitably qualified physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113051: Spacelabs Arkon Anesthesia Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113051
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026