510(k) · Cleared
Recalled · 2008GE Detax-Ohmeda Anesthesia Delivery Unit (Adu)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda, Inc. · BSZ Gas-Machine, Anesthesia
Cleared on Apr 12, 2005 as substantially equivalent to K042154 (Datex-Ohmeda, Inc., 2004) and 1 other predicate after a 27-day review. Its family tree reaches back 4 generations to 1994. 1 of the 11 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Apr 12, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 4 generations to K930017 (1994). 9 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK930017 PB 7200 Series Ventilatory System W/KeyboardPuritan Bennett Corp. · 1994
- 3 generations backK023366 Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · Recalled (Class I)
- 2 generations backK040743 Modification to Datex-Ohmeda S/5 Avance Anesthesia SystemDatex-Ohmeda, Inc. · 2004
- 1 generation backK042154 GE Datex-Ohmeda Aisys CarestationDatex-Ohmeda, Inc. · 2004 · Recalled
- This deviceK050676 GE Detax-Ohmeda Anesthesia Delivery Unit (Adu)Datex-Ohmeda, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK090892 GE Datex-Ohmeda S/5 Adu CarestationGE Healthcare Finland Oy · 2009 · Recalled
Class I recalls in this family
- K023366 Datex-Ohmeda 7900 Ventilator Enhancements3 generations back · 2003
Most influential descendants
Showing 1 of 1 · See all- K090892GE Datex-Ohmeda S/5 Adu CarestationGE Healthcare Finland Oy · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930017 | PB 7200 Series Ventilatory System W/Keyboard | Puritan Bennett Corp. | 1994 | — |
| −3 | K023366 | Datex-Ohmeda 7900 Ventilator Enhancements | Datex-Ohmeda, Inc. | 2003 | Class I |
| −2 | K040743 | Modification to Datex-Ohmeda S/5 Avance Anesthesia System | Datex-Ohmeda, Inc. | 2004 | — |
| −1 | K042154 | GE Datex-Ohmeda Aisys Carestation | Datex-Ohmeda, Inc. | 2004 | 3 |
| 0 (this device) | K050676 | GE Detax-Ohmeda Anesthesia Delivery Unit (Adu) | Datex-Ohmeda, Inc. | 2005 | — |
| +1 | K090892 | GE Datex-Ohmeda S/5 Adu Carestation | GE Healthcare Finland Oy | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
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 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 |
|---|---|---|---|
| * | K042154 | GE Datex-Ohmeda Aisys CarestationSummary page 1…y marketed device: GE Datex-Ohmeda ADU Carestation - Class 11 - 21 CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K042 154 Datex-Ohmeda AS/3 Anesthesia Delivery Unit - Class II - 21CFR868.5160, which has been the subject of a cle… | 2004 |
| * | K973985 | AS/3 Anaesthesia Delivery Unit (as/3 Adu)Summary page 1…K042 154 Datex-Ohmeda AS/3 Anesthesia Delivery Unit - Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K973985 The GE Datex-Ohmeda ADU is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patien… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090892 | GE Datex-Ohmeda S/5 Adu Carestation | 2009 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2008 | Not classified | Z-1633-2009 | Other | GE Healthcare has received reports of breathing circuit or tubing misconnections of the Anesthesia Delivery Unit (ADU), that may impact patient safety. |
| Oct 30, 2008 | Not classified | Z-1635-2009 | Other | GE Healthcare has received reports of breathing circuit or tubing misconnections of the Anesthesia Delivery Unit (ADU), that may impact patient safety. |
| Oct 30, 2008 | Not classified | Z-1634-2009 | Other | GE Healthcare has received reports of breathing circuit or tubing misconnections of the Anesthesia Delivery Unit (ADU), that may impact patient safety. |
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 11 years and passes through 2 companies; a new generation was cleared every 7 months on median.
- 5 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K090892 (GE Healthcare Finland Oy, 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K042154.
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 GE Datex-Ohmeda Anesthesia Delivery Unit 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.
https://510kreport.com/device/K050676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050676: GE Detax-Ohmeda Anesthesia Delivery Unit (Adu).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050676
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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