510(k) · Cleared
Recalled · 2008AS/3 Anaesthesia Delivery Unit (as/3 Adu)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Engstrom, Inc. · BSZ Gas-Machine, Anesthesia
Cleared on Oct 30, 1998 after a 375-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 46 of the 401 devices in its family, counting itself, have a Class I recall. 400 later devices descend from it. It has been recalled 8 times.
- Decided
- Oct 30, 1998
- Review
- 375 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- 8
- Predicates
- 0
400 later devices descend from it, 6 citing it directly. 46 of the 401 devices in this family, counting this one, have a Class I recall.
- This deviceK973985 AS/3 Anaesthesia Delivery Unit (as/3 Adu)Datex-Engstrom, Inc. · 1998
- Descendant · cites it directly · 270 of its ownK040847 Modification to Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2004
- Descendant · 2 generations on · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
- Descendant · 3 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · 4 generations on · 247 of its ownK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- Descendant · 4 generations on · 234 of its ownK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
Showing 5 of 400 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 400 · See all- K040847Modification to Vamos Anesthetic Gas MonitorDraeger Medical, Inc. · 2004 · cites it directly270descendants
- K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · 2 generations on251descendants
- K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 3 generations on249descendants
- K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 4 generations on247descendants
- K052801Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Philips Medizin Systeme Boeblingen GmbH · 2005 · 4 generations on234descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973985 | AS/3 Anaesthesia Delivery Unit (as/3 Adu) | Datex-Engstrom, Inc. | 1998 | — |
| +1 | K040847 | Modification to Vamos Anesthetic Gas Monitor | Draeger Medical, Inc. | 2004 | — |
| +2 | K041956 | Emg - Essential Gas Module, Model M1013A | Draeget Medical AG & Co. Kgaa | 2004 | — |
| +3 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +4 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| +4 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 1 |
| 2004 | 9 | 1 |
| 2005 | 13 | 0 |
| 2006 | 15 | 0 |
| 2007 | 8 | 2 |
| 2008 | 13 | 2 |
| 2009 | 13 | 2 |
| 2010 | 16 | 1 |
| 2011 | 23 | 7 |
| 2012 | 25 | 6 |
| 2013 | 22 | 4 |
| 2014 | 17 | 2 |
| 2015 | 15 | 1 |
| 2016 | 19 | 3 |
| 2017 | 19 | 4 |
| 2018 | 18 | 1 |
| 2019 | 15 | 3 |
| 2020 | 13 | 2 |
| 2021 | 19 | 2 |
| 2022 | 20 | 0 |
| 2023 | 23 | 2 |
| 2024 | 23 | 0 |
| 2025 | 23 | 0 |
| 2026 | 18 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
46 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (400)
See all 4006 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040847 | Modification to Vamos Anesthetic Gas Monitor | 2004 | 270 |
| K023366 | Datex-Ohmeda 7900 Ventilator Enhancements Class I | 2003 | 134 |
| K032803 | Datex-Ohmeda S/5 Avance Anesthesia System | 2004 | 39 |
| K042154 | GE Datex-Ohmeda Aisys Carestation | 2004 | 36 |
| K050676 | GE Detax-Ohmeda Anesthesia Delivery Unit (Adu) | 2005 | 1 |
| K090892 | GE Datex-Ohmeda S/5 Adu Carestation | 2009 | 0 |
Has anything in its family been recalled? (46 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. |
| Sep 11, 2006 | Not classified | Z-0291-2007 | Other | Certain Compact Absorbers may have an increased resistance to gas flow due to an improperly manufactured foam filter. The increased resistance can cause an elevated pressure at the ventilator end of the inspiratory circuit, but the… |
| Mar 22, 2006 | Not classified | Z-1196-06 | Other | There exists the possibility that the ADU Fresh Gas Control unit (A-FGC1) can shut off during normal handling of the anesthesia machine and result in no anesthetic agent output. |
| Nov 16, 2005 | Not classified | Z-0857-06 | Other | Alarm sound-It is possible that the audible alarms from the speaker from the Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU) machine may dampen or disappear as a result of normal handling of the anesthesia machine. Visual alarms on the… |
| Feb 3, 2004 | Not classified | Z-0545-04 | Other | Anesthetic agents could be delivered at concentrations above the concentration set on the S/5 and AS/3 Anesthesia Delivery Units (ADU) having serial numbers within a specified range. |
| Jul 15, 2003 | Not classified | Z-0937-03 | Other | Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery. |
The 5 latest of 8 recalls; the web page lists all.
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 · Cites it directly · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
- K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900…Datex-Ohmeda, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 110 Class I recalls
- K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
- K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K133886Perseus A500Draeger Medical GmbH · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 4 generations on · ◆ in the 2009 descendants bar of FIG. 15 Class I recalls
- K070899Puritan Bennett Legendair XL2Nellcor Puritan Bennett · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K122445Aespire 7900, Aespire ViewDatex-Ohmeda · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 18 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 5 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
Nearest 12 of 46 shown.
Nearest 5 of 46; all are on the web page.
What does this lineage say?
- Of its descendants, K040847 (Draeger Medical, Inc., 2004) has gone furthest, with 270 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 AS/3™ Anaesthesia Delivery Unit (AS/3™ ADU) is an Anesthesia Gas Machine for composition of anesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia.
The AS/3™ ADU is indicated for all persons that require inhalation anesthesia.
The AS/3™ ADU shall be operated by qualified anesthesia personnel.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973985: AS/3 Anaesthesia Delivery Unit (as/3 Adu).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973985
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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