510(k) · Cleared
Recalled · Class II · 2015BLEASE700/900 Series Ventilators
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 Jun 11, 2012 as substantially equivalent to K101850 (Spacelabs Healthcare, Ltd., 2011) after a 265-day review. Its family tree reaches back 4 generations to 1999. 2 of the 6 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Jun 11, 2012
- Review
- 265 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1
- 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. 2 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 deviceK112729 BLEASE700/900 Series VentilatorsSpacelabs 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) | K112729 | BLEASE700/900 Series Ventilators | 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.
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? (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 1…ilators Continuous Ventilator Continuous Ventilator 21 CFR §868.5895 CBK New Spacelabs Model Predicate Predicate 510(k) Number Manufacturer / Model Spacelabs Blease 900 K101850 Spacelabs BleaseSirius Series Ventilators Anesthesia Workstation 24 May 2011 Page 1 of 5 464… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2015 | Class II | Z-1458-2015 | Vendor change control | 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… |
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 Blease 900 Series Ventilators are advanced, microprocessor-controlled, pneumatically driven ventilators, which have been designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112729: BLEASE700/900 Series Ventilators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112729
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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