510(k) · Cleared
Recalled · 2002Blease 6200 Anaesthesia Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blease Medical Equipment, Ltd. · CBK Ventilator, Continuous, Facility Use
Cleared on Apr 15, 1999 after a 302-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 6 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled once.
- Decided
- Apr 15, 1999
- Review
- 302 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly. 2 of the 6 devices in this family, counting this one, have a Class I recall.
- This deviceK982132 Blease 6200 Anaesthesia VentilatorBlease Medical Equipment, Ltd. · 1999
- Descendant · cites it directly · 4 of its ownK041430 Blease Sirius Anesthesia System, Models 3000 and 2000Blease Medical Equipment, Ltd. · 2004
- Descendant · 2 generations on · 3 of its ownK051629 Bleas Esiriuc Anaesthsia System, Models 3000, 2000Blease USA, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 2 of its ownK101850 Spacelabs Bleasesirius Anesthesia WorkstationSpacelabs Healthcare, Ltd. · 2011 · Recalled (Class I)
- Descendant · 4 generations on · 0 of its ownK112729 BLEASE700/900 Series VentilatorsSpacelabs Healthcare · 2012 · Recalled
- Descendant · 4 generations on · 0 of its ownK113051 Spacelabs Arkon Anesthesia WorkstationSpacelabs Healthcare · 2012 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K041430Blease Sirius Anesthesia System, Models 3000 and 2000Blease Medical Equipment, Ltd. · 2004 · cites it directly4descendants
- K051629Bleas Esiriuc Anaesthsia System, Models 3000, 2000Blease USA, Inc. · 2005 · 2 generations on3descendants
- K101850Spacelabs Bleasesirius Anesthesia WorkstationSpacelabs Healthcare, Ltd. · 2011 · 3 generations on2descendants
- K112729BLEASE700/900 Series VentilatorsSpacelabs Healthcare · 2012 · 4 generations on0descendants
- K113051Spacelabs Arkon Anesthesia WorkstationSpacelabs Healthcare · 2012 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982132 | Blease 6200 Anaesthesia Ventilator | Blease Medical Equipment, Ltd. | 1999 | — |
| +1 | 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 |
| +3 | K101850 | Spacelabs Bleasesirius Anesthesia Workstation | Spacelabs Healthcare, Ltd. | 2011 | Class I |
| +4 | K112729 | BLEASE700/900 Series Ventilators | Spacelabs Healthcare | 2012 | 1 |
| +4 | K113051 | Spacelabs Arkon Anesthesia Workstation | Spacelabs Healthcare | 2012 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 1 |
| 2012 | 2 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041430 | Blease Sirius Anesthesia System, Models 3000 and 2000 | 2004 | 4 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2002 | Not classified | Z-0165-04 | Other | Assay may produce falsely low IgM results without error codes when testing specimens contain elevated serum paraproteins associated with various myeloma or other malignancies. |
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 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K113051Spacelabs Arkon Anesthesia WorkstationSpacelabs Healthcare · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- Of its descendants, K041430 (Blease Medical Equipment, Ltd., 2004) has gone furthest, with 4 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.
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 Blease 6200 anaesthesia ventilator is an advanced microprocessor controlled, pneumatically driven ventilator (controller) specifically designed for mechanical ventilation of adult and paediatric patients under general anaesthesia.
It is designed for use with a circle type absorber and is ideally suited to both low-flow and high-flow applications. The ventilator may also be used with either a Bain-type coaxial circuit or a Jackson-Rees/Ayres T-piece type paediatric circuit with no modification being necessary.
The device is intended for use only by a suitably qualified physician.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982132 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982132: Blease 6200 Anaesthesia Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982132
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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