510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

GE Datex-Ohmeda S/5 Adu Carestation

K090892510(k) SpecialCleared Apr 30, 200930-day reviewClass II21 CFR 868.5160Recalls 1

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

GE Healthcare Finland Oy · BSZ Gas-Machine, Anesthesia

Cleared on Apr 30, 2009 as substantially equivalent to K050676 (Datex-Ohmeda, Inc., 2005) and 5 other predicates after a 30-day review. Its family tree reaches back 8 generations to 1994. 1 of the 16 devices in its family, counting itself, has a Class I recall. It has been recalled once.

Decided
Apr 30, 2009
Review
30 days
Class
Class II
Product code
BSZ
Recalls
1
Predicates
6

Its longest line of descent runs back 8 generations to K930017 (1994). 15 ancestors in all. No later device cites it as a predicate yet. 1 of the 16 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2008: 1 other ancestor2005: 1 other ancestor1998: 2 other ancestors2004: 1 other ancestor2000: 1 other ancestor1996: 1 other ancestorK930017 · PB 7200 Series Ventilatory System W/Keyboard · Puritan Bennett Corp. · 1994K023366 · Datex-Ohmeda 7900 Ventilator Enhancements · Datex-Ohmeda, Inc. · 2003 · Class I recallK040743 · Modification to Datex-Ohmeda S/5 Avance Anesthesia System · Datex-Ohmeda, Inc. · 2004K042154 · GE Datex-Ohmeda Aisys Carestation · Datex-Ohmeda, Inc. · 2004 · recalledK061609 · GE Datex-Ohmeda Aisys · Datex-Ohmeda, Inc. · 2006 · recalledK071142 · GE Datex-Ohmeda Avance Anesthesia System · Datex-Ohmeda · 2007K081844 · GE Datex-Ohmeda Avance · Datex-Ohmeda, Inc. · 2008 · recalledK090233 · GE Datex-Ohmeda Aisys · Datex-Ohmeda, Inc. · 2009 · recalled19901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 1 other ancestor K090233 · GE Datex-Ohmeda Aisys · Datex-Ohmeda, Inc. · 2009 · recalledK081844 · GE Datex-Ohmeda Avance · Datex-Ohmeda, Inc. · 2008 · recalledK071142 · GE Datex-Ohmeda Avance Anesthesia System · Datex-Ohmeda · 2007K061609 · GE Datex-Ohmeda Aisys · Datex-Ohmeda, Inc. · 2006 · recalledK042154 · GE Datex-Ohmeda Aisys Carestation · Datex-Ohmeda, Inc. · 2004 · recalledK040743 · Modification to Datex-Ohmeda S/5 Avance Anesthesia System · Datex-Ohmeda, Inc. · 2004K023366 · Datex-Ohmeda 7900 Ventilator Enhancements · Datex-Ohmeda, Inc. · 2003 · Class I recallK930017 · PB 7200 Series Ventilatory System W/Keyboard · Puritan Bennett Corp. · 1994−50
  1. Root · 8 generations backK930017 PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp. · 1994
  2. 7 generations backK023366 Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · Recalled (Class I)
  3. 6 generations backK040743 Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda, Inc. · 2004
  4. 5 generations backK042154 GE Datex-Ohmeda Aisys CarestationDatex-Ohmeda, Inc. · 2004 · Recalled
  5. 4 generations backK061609 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2006 · Recalled
  6. 3 generations backK071142 GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda · 2007
  7. 2 generations backK081844 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2008 · Recalled
  8. 1 generation backK090233 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2009 · Recalled
  9. This deviceK090892 GE Datex-Ohmeda S/5 Adu CarestationGE Healthcare Finland Oy · 2009

Class I recalls in this family

  • K023366 Datex-Ohmeda 7900 Ventilator Enhancements3 generations back · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K930017PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp.1994—
−7K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc.2003Class I
−6K040743Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda, Inc.2004—
−5K042154GE Datex-Ohmeda Aisys CarestationDatex-Ohmeda, Inc.20043
−4K061609GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20061
−3K071142GE Datex-Ohmeda Avance Anesthesia SystemDatex-Ohmeda2007—
−2K081844GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc.20084
−1K090233GE Datex-Ohmeda AisysDatex-Ohmeda, Inc.20092
0 (this device)K090892GE Datex-Ohmeda S/5 Adu CarestationGE Healthcare Finland Oy2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199820
200010
200410
200510
200810
FIG. 1 — Lineage of K090892, 1994–2009Source: 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), 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.

1 device in this family has 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? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K050676GE Detax-Ohmeda Anesthesia Delivery Unit (Adu)
Summary page 1
…U Carestation is substantially equivalent in safety and effectiveness to the legally marketed (predicate) GE Datex-Ohmeda Anesthesia Delivery Unit (ADU) (K050676, K973985) and GE Aisys anesthesia machine (K090233, K073707,K061609,K0421541.…
Datex-Ohmeda, Inc.20053
*K973985AS/3 Anaesthesia Delivery Unit (as/3 Adu)
Summary page 1
…tion is substantially equivalent in safety and effectiveness to the legally marketed (predicate) GE Datex-Ohmeda Anesthesia Delivery Unit (ADU) (K050676, K973985) and GE Aisys anesthesia machine (K090233, K073707,K061609,K0421541. 13…
Datex-Engstrom, Inc.19988
*K090233GE Datex-Ohmeda Aisys
Summary page 1
…and effectiveness to the legally marketed (predicate) GE Datex-Ohmeda Anesthesia Delivery Unit (ADU) (K050676, K973985) and GE Aisys anesthesia machine (K090233, K073707,K061609,K0421541. 13…
Datex-Ohmeda, Inc.20092
*K073707GE Datex-Ohmeda Aisys
Summary page 1
…ctiveness to the legally marketed (predicate) GE Datex-Ohmeda Anesthesia Delivery Unit (ADU) (K050676, K973985) and GE Aisys anesthesia machine (K090233, K073707,K061609,K0421541. 13…
Datex-Ohmeda, Inc.20082
*K061609GE Datex-Ohmeda Aisys
Summary page 1
…s to the legally marketed (predicate) GE Datex-Ohmeda Anesthesia Delivery Unit (ADU) (K050676, K973985) and GE Aisys anesthesia machine (K090233, K073707,K061609,K0421541. 13…
Datex-Ohmeda, Inc.20061
*K042154GE Datex-Ohmeda Aisys Carestation
Summary page 1
…legally marketed (predicate) GE Datex-Ohmeda Anesthesia Delivery Unit (ADU) (K050676, K973985) and GE Aisys anesthesia machine (K090233, K073707,K061609,K0421541. 13…
Datex-Ohmeda, Inc.20043

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 14, 2013Class IIZ-1443-2013Component change controlGE Healthcare has recently become aware of a potential safety issue involving the reusable CO2 absorbent canister accessory used with Aespire, Aespire View, Avance, Avance CS2, Aisys, ADU, 9100, M900, M904, 9300 systems. Reusable CO2…

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.

  • K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 11 months on median.
  • 10 of the 15 ancestors have a recall of any class; 1 has a Class I recall.

How does its category compare?

All BSZ devices

BSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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)—

What is it indicated for?

The GE Datex-Ohmeda S/5 ADU Carestation is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes. The ADU is not suitable for use in a MRI environment.

Indications for use as stated in the FDA summary.

More from GE Healthcare Finland Oy

32 FDA decisions under this applicant name. See the company

  • K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
  • K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026
  • K223531CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)GE Healthcare Finland Oy · 20233 recalls
  • K213363CARESCAPE B450, E-musbGE Healthcare Finland Oy · 20221 recall
  • K213181CARESCAPE B650, E-musbGE Healthcare Finland Oy · 20222 recalls

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/K090892 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090892: GE Datex-Ohmeda S/5 Adu Carestation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090892

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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