510(k) · Cleared
Recalled · 2010Bleas Esiriuc Anaesthsia System, Models 3000, 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blease USA, Inc. · BSZ Gas-Machine, Anesthesia
Cleared on Sep 23, 2005 as substantially equivalent to K041430 (Blease Medical Equipment, Ltd., 2004) after a 95-day review. Its family tree reaches back 2 generations to 1999. 3 of the 7 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 23, 2005
- Review
- 95 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K982132 (1999). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly. 3 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK982132 Blease 6200 Anaesthesia VentilatorBlease Medical Equipment, Ltd. · 1999 · Recalled
- 1 generation backK041430 Blease Sirius Anesthesia System, Models 3000 and 2000Blease Medical Equipment, Ltd. · 2004
- This deviceK051629 Bleas Esiriuc Anaesthsia System, Models 3000, 2000Blease USA, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK101850 Spacelabs Bleasesirius Anesthesia WorkstationSpacelabs Healthcare, Ltd. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK112729 BLEASE700/900 Series VentilatorsSpacelabs Healthcare · 2012 · Recalled
- Descendant · 2 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 3 of 3 · See all- K101850Spacelabs Bleasesirius Anesthesia WorkstationSpacelabs Healthcare, Ltd. · 2011 · cites it directly2descendants
- K112729BLEASE700/900 Series VentilatorsSpacelabs Healthcare · 2012 · 2 generations on0descendants
- K113051Spacelabs Arkon Anesthesia WorkstationSpacelabs Healthcare · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982132 | Blease 6200 Anaesthesia Ventilator | Blease Medical Equipment, Ltd. | 1999 | 1 |
| −1 | K041430 | Blease Sirius Anesthesia System, Models 3000 and 2000 | Blease Medical Equipment, Ltd. | 2004 | — |
| 0 (this device) | K051629 | Bleas Esiriuc Anaesthsia System, Models 3000, 2000 | Blease USA, Inc. | 2005 | — |
| +1 | K101850 | Spacelabs Bleasesirius Anesthesia Workstation | Spacelabs Healthcare, Ltd. | 2011 | Class I |
| +2 | K112729 | BLEASE700/900 Series Ventilators | Spacelabs Healthcare | 2012 | 1 |
| +2 | 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 |
|---|---|---|
| 2011 | 1 | 1 |
| 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 BSZ device
- #1 K253330 A5 Anesthesia System (A5); A7 Anesthesia…score 16.7 · 18 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 |
|---|---|---|---|
| * | K041430 | Blease Sirius Anesthesia System, Models 3000 and 2000Summary page 1…ntline Sirius 2000, 3000 Classification Code: BSZ Classification Name: Anaesthesia Gas Machine Blease Frontline Sirius K041430 Predicate Device: Device Description/ Comparison: The Frontline Sirius with 8700 ventilator is… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101850 | Spacelabs Bleasesirius Anesthesia Workstation Class I | 2011 | 2 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2010 | Not classified | Z-2113-2010 | Other | Potential for the touch screen on the ventilator portion of the device to go blank when touched. Possibility that this failure may also cause mechanical ventilation to stop. |
| Mar 26, 2010 | Not classified | Z-1408-2010 | Other | Potential for delivery of a lower than set concentration of anaesthetic to a patient due to a sticking valve. The lower shuttle may become jammed, not permitting flow of anaesthesia gas through the vapouriser. The vapouriser back bar… |
| Jun 25, 2009 | Not classified | Z-0813-2011 | Other | Users may experience difficulty turning the control knob to an active vapour delivery setting, or may not be able to turn on the Left Hand mounted vapouriser on the Blease Sirius Anaesthesia Systems. |
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 · 2 generations back · ◆ in the 2001 ancestors bar of FIG. 12 Class I recalls
- K101850Spacelabs Bleasesirius Anesthesia WorkstationSpacelabs Healthcare, Ltd. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K113051Spacelabs Arkon Anesthesia WorkstationSpacelabs Healthcare · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K101850 (Spacelabs Healthcare, Ltd., 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BSZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSZ
145in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSZ
5in 2025
Class I (38 since 2007) Class II/III not classified
Adverse event reports per year · BSZ
9,198in 2025
MAUDE reports naming product code BSZ, 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 | 3 | 175 | 1 | 132 |
| 2008 | 8 | 99 | 8 | 104 |
| 2009 | 3 | 34 | 3 | 85 |
| 2010 | 1 | — | 14 | 97 |
| 2011 | 6 | 218 | 1 | 87 |
| 2012 | 5 | 134 | 7 (6) | 89 |
| 2013 | 5 | 125 | 5 (5) | 308 |
| 2014 | 4 | 235 | 0 | 279 |
| 2015 | 4 | 134 | 7 (2) | 572 |
| 2016 | 1 | — | 1 | 2,135 |
| 2017 | 3 | 145 | 5 (1) | 2,355 |
| 2018 | 2 | — | 3 | 2,589 |
| 2019 | 0 | — | 5 (2) | 1,957 |
| 2020 | 1 | — | 7 | 2,687 |
| 2021 | 1 | — | 2 (1) | 3,123 |
| 2022 | 0 | — | 4 (3) | 4,352 |
| 2023 | 2 | — | 6 | 5,595 |
| 2024 | 0 | — | 13 (13) | 6,067 |
| 2025 | 1 | — | 5 (3) | 9,198 |
| 2026 | 2 | — | 7 (2) | — |
What is it indicated for?
The Blease Frontline Sirius Range, Anaesthesia Machines are 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 a mechanical ventilator, and may be used for the delivery of anaesthetic vapour 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/K051629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051629: Bleas Esiriuc Anaesthsia System, Models 3000, 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051629
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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