# K113051: Spacelabs Arkon Anesthesia Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Healthcare
- Decided: Mar 22, 2012 after 161 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 6 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K982132 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
3 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101850: Spacelabs Bleasesirius Anesthesia Workstation, Spacelabs Healthcare, Ltd. (2011) Summary page 2.

## Recalls of this device
- Jul 11, 2018 · Class I · Z-2589-2018: Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
- Oct 11, 2017 · Class I · Z-0072-2018: Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical ventilation, oxygen and anesthetic gas delivery, with concurrent failure of the display unit that resulted i
- Apr 14, 2017 · Class II · Z-2093-2017: Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient.
- Feb 8, 2017 · Class II · Z-1460-2017: Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model 99999, shutting down without warning. The power supply has failed in a way that does not trigger the normal on battery a
- Mar 10, 2014 · Class I · Z-1442-2014: The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.
- Jun 7, 2013 · Class II · Z-1771-2013: Spacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer w

## Indications for use
The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.

Source page: https://510kreport.com/device/K113051
Methodology: https://510kreport.com/methodology