510(k) · Cleared
ClearedBlease Sirius Anesthesia System, Models 3000 and 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blease Medical Equipment, Ltd. · BSZ Gas-Machine, Anesthesia
Cleared on Oct 7, 2004 as substantially equivalent to K003251 (Blease Medical Equipment, Ltd., 2001) and 1 other predicate after a 132-day review. Its family tree reaches back 1 generation to 1999. 3 of the 7 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it.
- Decided
- Oct 7, 2004
- Review
- 132 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K982132 (1999). 2 ancestors in all. 4 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 · 1 generation backK982132 Blease 6200 Anaesthesia VentilatorBlease Medical Equipment, Ltd. · 1999 · Recalled
- This deviceK041430 Blease Sirius Anesthesia System, Models 3000 and 2000Blease Medical Equipment, Ltd. · 2004
- Descendant · cites it directly · 3 of its ownK051629 Bleas Esiriuc Anaesthsia System, Models 3000, 2000Blease USA, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 2 of its ownK101850 Spacelabs Bleasesirius Anesthesia WorkstationSpacelabs Healthcare, Ltd. · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK112729 BLEASE700/900 Series VentilatorsSpacelabs Healthcare · 2012 · Recalled
- Descendant · 3 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 4 of 4 · See all- K051629Bleas Esiriuc Anaesthsia System, Models 3000, 2000Blease USA, Inc. · 2005 · cites it directly3descendants
- K101850Spacelabs Bleasesirius Anesthesia WorkstationSpacelabs Healthcare, Ltd. · 2011 · 2 generations on2descendants
- K112729BLEASE700/900 Series VentilatorsSpacelabs Healthcare · 2012 · 3 generations on0descendants
- K113051Spacelabs Arkon Anesthesia WorkstationSpacelabs Healthcare · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982132 | Blease 6200 Anaesthesia Ventilator | Blease Medical Equipment, Ltd. | 1999 | 1 |
| 0 (this device) | 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 |
| +2 | K101850 | Spacelabs Bleasesirius Anesthesia Workstation | Spacelabs Healthcare, Ltd. | 2011 | Class I |
| +3 | K112729 | BLEASE700/900 Series Ventilators | Spacelabs Healthcare | 2012 | 1 |
| +3 | 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 |
|---|---|---|
| 2005 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K003251 | Blease Frontline Plus Range, Anesthesia Machines, Model 440, 560 and 690Summary page 1…e Sirius 2000, 3000 Classification Code: BSZ Classification Name: Anaesthesia Gas Machine Predicate Device: Blease Frontline Plus K003251 Blease 6200 Ventilator K982132 Device Description/ Comparison:… | 2001 |
| * | K982132 | Blease 6200 Anaesthesia VentilatorSummary page 1…ation Name: Anaesthesia Gas Machine Predicate Device: Blease Frontline Plus K003251 Blease 6200 Ventilator K982132 Device Description/ Comparison: The Frontline Sirius is similar to the cleared… | 1999 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051629 | Bleas Esiriuc Anaesthsia System, Models 3000, 2000 | 2005 | 3 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
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 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 12 Class I recalls
- K101850Spacelabs Bleasesirius Anesthesia WorkstationSpacelabs Healthcare, Ltd. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K113051Spacelabs Arkon Anesthesia WorkstationSpacelabs Healthcare · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K051629 (Blease USA, Inc., 2005) has gone furthest, with 3 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?
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 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/K041430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041430: Blease Sirius Anesthesia System, Models 3000 and 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041430
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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