# K973896: Ohmeda Excel 3000 Anesthesia System

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Apr 21, 1998 after 189 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
137 later devices descend from it; 3 cite it directly.
44 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ohmeda Excel Series Anesthesia Machines: named in the summary without a submission number
- (no number) Ohmeda APAC (Advanced Portable Anesthesia Care) System: named in the summary without a submission number
- (no number) Ohmeda 7900 Anesthesia Ventilator: named in the summary without a submission number

## Most influential descendants
- K023366: Datex-Ohmeda 7900 Ventilator Enhancements (2003), 134 descendants of its own
- K041775: GE Datex-Ohmeda Engstrom Carestation (2004), 107 descendants of its own
- K051767: LTV 1000 Ventilator (2005), 57 descendants of its own
- K051895: GE Datex-Ohmeda Engstrom Carestation (2005), 49 descendants of its own
- K060862: GE Datex-Ohmeda Engstrom Carestation (2006), 48 descendants of its own

## Recalls of this device
- Apr 16, 2004 · Not classified · Z-0967-04: Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.

## Indications for use
The Excel 3000 Anesthesia Gas System is a gas machine that supplies set flows of medical gases to the breathing system. A large selection of frames, gases, vaporizers and ventilators, give full control of the system configuration. The Excel 3000 is available in wide or narrow trolley and pendant models. The narrow trolley and pendant come with two or three gases, two vaporizer positions and up to four cylinder connections. The wide trolley comes with two, three or four gases, three vaporizer positions and up to five cylinder connections. All models have O2 and N20. The Excel 3000 comes with up to two optional gases (air, CO2, heliox). All Excel systems accept Tec 4, Tec 5 and Tec 6 vaporizers. Excel 3000 systems use either the 7900 Ventilator, 7800 Ventilator, or the 7000 Ventilator, along with being able to accept integral monitors for vital signs and respiratory gases. Safety features and devices within the Excel 3000 decrease the risk of hypoxnc mixtures, ‘agent mixtures and.complete power or sudden gas supply-failures.- -

Source page: https://510kreport.com/device/K973896
Methodology: https://510kreport.com/methodology