# K080175: Navigator Anesthesia Delivery System, Model 0998-00-3024-01

- Pathway: 510(k) (Abbreviated)
- Applicant: Datascope Corp., Patient Monitoring Division
- Decided: Jun 9, 2008 after 137 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K930017 (1994). 12 ancestors in all.
11 later devices descend from it; 2 cite it directly.
2 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001988: Modular, Heyer America, Inc. (2001)
- K071142: GE Datex-Ohmeda Avance Anesthesia System, Datex-Ohmeda (2007) Summary page 1.

## Most influential descendants
- K102471: AS3700 Anesthsia Delivery System (2011), 9 descendants of its own
- K123211: A5 Anesthesia Delivery System (2013), 8 descendants of its own
- K142552: A7 Anesthesia System (2015), 5 descendants of its own
- K151954: A7 Anesthesia System (2015), 4 descendants of its own
- K171292: A7 Anesthesia System (2018), 3 descendants of its own

## Recalls of this device
- Mar 5, 2010 · Not classified · Z-1313-2010: An issue affecting the caster mount on the AS3000 System have been identified, specifically reports of the caster mount breaking, causing the wheel to fall off and the unit to tip.
- Oct 7, 2008 · Not classified · Z-0319-2009: Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2

## Indications for use
The Navigator Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The Navigator is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in both adult and pediatric populations.

Source page: https://510kreport.com/device/K080175
Methodology: https://510kreport.com/methodology