# K973985: AS/3 Anaesthesia Delivery Unit (as/3 Adu)

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Engstrom, Inc.
- Decided: Oct 30, 1998 after 375 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
400 later devices descend from it; 6 cite it directly.
46 of 401 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040847: Modification to Vamos Anesthetic Gas Monitor (2004), 270 descendants of its own
- K041956: Emg - Essential Gas Module, Model M1013A (2004), 251 descendants of its own
- K050762: Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90 (2005), 249 descendants of its own
- K051106: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors (2005), 247 descendants of its own
- K052801: Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 (2005), 234 descendants of its own

## Recalls of this device
- Oct 30, 2008 · Not classified · Z-1633-2009: 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: 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: 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: 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 t
- Mar 22, 2006 · Not classified · Z-1196-06: 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: 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 anest
- Feb 3, 2004 · Not classified · Z-0545-04: 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: Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.

## Indications for use
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.

Source page: https://510kreport.com/device/K973985
Methodology: https://510kreport.com/methodology