510(k) · Cleared
Recalled · Class I · 2013Spacelabs Bleasesirius Anesthesia Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Healthcare, Ltd. · CBK Ventilator, Continuous, Facility Use
Cleared on Mar 2, 2011 as substantially equivalent to K051629 (Blease USA, Inc., 2005) after a 244-day review. Its family tree reaches back 3 generations to 1999. 3 of the 7 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Mar 2, 2011
- Review
- 244 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to K982132 (1999). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly. 3 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK982132 Blease 6200 Anaesthesia VentilatorBlease Medical Equipment, Ltd. · 1999 · Recalled
- 2 generations backK041430 Blease Sirius Anesthesia System, Models 3000 and 2000Blease Medical Equipment, Ltd. · 2004
- 1 generation backK051629 Bleas Esiriuc Anaesthsia System, Models 3000, 2000Blease USA, Inc. · 2005 · Recalled
- This deviceK101850 Spacelabs Bleasesirius Anesthesia WorkstationSpacelabs Healthcare, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK112729 BLEASE700/900 Series VentilatorsSpacelabs Healthcare · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK113051 Spacelabs Arkon Anesthesia WorkstationSpacelabs Healthcare · 2012 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982132 | Blease 6200 Anaesthesia Ventilator | Blease Medical Equipment, Ltd. | 1999 | 1 |
| −2 | K041430 | Blease Sirius Anesthesia System, Models 3000 and 2000 | Blease Medical Equipment, Ltd. | 2004 | — |
| −1 | K051629 | Bleas Esiriuc Anaesthsia System, Models 3000, 2000 | Blease USA, Inc. | 2005 | 3 |
| 0 (this device) | K101850 | Spacelabs Bleasesirius Anesthesia Workstation | Spacelabs Healthcare, Ltd. | 2011 | — |
| +1 | K112729 | BLEASE700/900 Series Ventilators | Spacelabs Healthcare | 2012 | 1 |
| +1 | K113051 | Spacelabs Arkon Anesthesia Workstation | Spacelabs Healthcare | 2012 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 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 |
|---|---|---|---|
| * | K051629 | Bleas Esiriuc Anaesthsia System, Models 3000, 2000Summary page 1…dicate Predicate Equivalent Devices: 510(k) Number Manufacturer/ Model Spacelabs BleaseSirius K05 1629 Spacelabs Blease Anesthesia Workstation Frontline Sirius 2000,… | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2013 | Class I | Z-0968-2013 | Process control | 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. |
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.
- K003251Blease Frontline Plus Range, Anesthesia Machines, Model 440, 560 and 690Blease Medical Equipment, Ltd. · 2001 · 3 generations back · ◆ in the 2001 ancestors bar of FIG. 12 Class I recalls
- K113051Spacelabs Arkon Anesthesia WorkstationSpacelabs Healthcare · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 3 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K112729 (Spacelabs Healthcare, 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 BleaseSirius 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/K101850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101850: Spacelabs Bleasesirius 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/K101850
Report an extraction error
Are you the manufacturer?
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