510(k) Report

510(k) · Cleared

Recalled · Class I · 2013

Blease Frontline Plus Range, Anesthesia Machines, Model 440, 560 and 690

K003251510(k) TraditionalCleared May 23, 2001218-day reviewClass II21 CFR 868.5160Recalls 3 (2 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Blease Medical Equipment, Ltd. · BSZ Gas-Machine, Anesthesia

Cleared on May 23, 2001 after a 218-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 6 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 3 times, including 2 Class I recalls.

Decided
May 23, 2001
Review
218 days
Class
Class II
Product code
BSZ
Recalls
3 (2 Class I)
Predicates
0

5 later devices descend from it, 1 citing it directly. 3 of the 6 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2004: 1 descendant cleared2005: 1 descendant cleared2011: 1 descendant cleared, 1 with a Class I recall12012: 2 descendants cleared, 1 with a Class I recall1200020052010201520202025
  1. This deviceK003251 Blease Frontline Plus Range, Anesthesia Machines, Model 440, 560 and…Blease Medical Equipment, Ltd. · 2001
  2. Descendant · cites it directly · 4 of its ownK041430 Blease Sirius Anesthesia System, Models 3000 and 2000Blease Medical Equipment, Ltd. · 2004
  3. Descendant · 2 generations on · 3 of its ownK051629 Bleas Esiriuc Anaesthsia System, Models 3000, 2000Blease USA, Inc. · 2005 · Recalled
  4. Descendant · 3 generations on · 2 of its ownK101850 Spacelabs Bleasesirius Anesthesia WorkstationSpacelabs Healthcare, Ltd. · 2011 · Recalled (Class I)
  5. Descendant · 4 generations on · 0 of its ownK112729 BLEASE700/900 Series VentilatorsSpacelabs Healthcare · 2012 · Recalled
  6. Descendant · 4 generations on · 0 of its ownK113051 Spacelabs Arkon Anesthesia WorkstationSpacelabs Healthcare · 2012 · Recalled (Class I)

Class I recalls in this family

  • K101850 Spacelabs Bleasesirius Anesthesia Workstation3 generations on · 2011
  • K113051 Spacelabs Arkon Anesthesia Workstation4 generations on · 2012

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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003251Blease Frontline Plus Range, Anesthesia Machines, Model 440, 560 and 690Blease Medical Equipment, Ltd.2001—
+1K041430Blease Sirius Anesthesia System, Models 3000 and 2000Blease Medical Equipment, Ltd.2004—
+2K051629Bleas Esiriuc Anaesthsia System, Models 3000, 2000Blease USA, Inc.20053
+3K101850Spacelabs Bleasesirius Anesthesia WorkstationSpacelabs Healthcare, Ltd.2011Class I
+4K112729BLEASE700/900 Series VentilatorsSpacelabs Healthcare20121
+4K113051Spacelabs Arkon Anesthesia WorkstationSpacelabs Healthcare2012Class I

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
201111
201221
FIG. 1 — Lineage of K003251, 2001–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K253330 A5 Anesthesia System (A5); A7 Anesthesia…score 16.7 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041430Blease Sirius Anesthesia System, Models 3000 and 2000Blease Medical Equipment, Ltd.20044

Has anything in its family been recalled? (3 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 17, 2013Class IZ-0352-2014Process controlSpacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber.
Jan 15, 2013Class IZ-0968-2013Process controlA 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.
Nov 2, 2012Class IIZ-0565-2013Labeling designThe BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were shipped with manuals that describe a secondary O2 Supply Failure alarm which has not been incorporated into the system. The manuals were prematurely updated for a…

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 BSZ devices

BSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BSZ

1in 2025

2007: 32008: 82009: 32010: 12011: 62012: 52013: 52014: 42015: 42016: 12017: 32018: 22020: 12021: 12023: 22025: 12026 (partial year): 2
2007high 8 (2008) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSZ

145in 2017

2007: 175 days median2008: 99 days median2009: 34 days median2011: 218 days median2012: 134 days median2013: 125 days median2014: 235 days median2015: 134 days median2017: 145 days median
2007high 235 (2014) · low 34 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BSZ

5in 2025

2007: 12008: 82009: 32010: 142011: 12012: 7, 6 Class I2013: 5, 5 Class I2015: 7, 2 Class I2016: 12017: 5, 1 Class I2018: 32019: 5, 2 Class I2020: 72021: 2, 1 Class I2022: 4, 3 Class I2023: 62024: 13, 13 Class I2025: 5, 3 Class I2026 (partial year): 7, 2 Class I
2007high 14 (2010) · low 0 (2014)2026

Class I (38 since 2007) Class II/III not classified

Adverse event reports per year · BSZ

9,198in 2025

2007: 1322008: 1042009: 852010: 972011: 872012: 892013: 3082014: 2792015: 5722016: 2,1352017: 2,3552018: 2,5892019: 1,9572020: 2,6872021: 3,1232022: 4,3522023: 5,5952024: 6,0672025: 9,198
2007high 9,198 (2025) · low 85 (2009)2025

MAUDE reports naming product code BSZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200731751132
20088998104
2009334385
20101—1497
20116218187
201251347 (6)89
201351255 (5)308
201442350279
201541347 (2)572
20161—12,135
201731455 (1)2,355
20182—32,589
20190—5 (2)1,957
20201—72,687
20211—2 (1)3,123
20220—4 (3)4,352
20232—65,595
20240—13 (13)6,067
20251—5 (3)9,198
20262—7 (2)—

More from Blease Medical Equipment, Ltd.

5 FDA decisions under this applicant name. See the company

  • K041430Blease Sirius Anesthesia System, Models 3000 and 2000Blease Medical Equipment, Ltd. · 2004
  • K001727Modification to Blease Frontline Genius Range, Anesthesia MachinesBlease Medical Equipment, Ltd. · 2000
  • K982132Blease 6200 Anaesthesia VentilatorBlease Medical Equipment, Ltd. · 19991 recall
  • K982137Blease Frontline Genius Range Anaesthesia MachineBlease Medical Equipment, Ltd. · 1999

Recent decisions in BSZ

The BSZ category page

  • K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K252746Atlan (A100); Atlan (A100 XL); Atlan (A350); Atlan (A350 XL)Drägerwerk AG Co. Kgaa · 2026
  • K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series…Codonics.Incorporated · 2025
  • K230931AtlanDrägerwerk AG Co. Kgaa · 20238 Class I recalls
  • K213867Carestation 750/750cDatex-Ohmeda, Inc. · 20234 Class I recalls

https://510kreport.com/device/K003251 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003251: Blease Frontline Plus Range, Anesthesia Machines, Model 440, 560 and 690.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003251

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026