# K965041: Ohmeda Apac (Advanced Portable Anesthesia Care) System

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Jun 17, 1997 after 182 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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

## Indications for use
The APAC is a self-contained, portable and lightweight anesthesia machine that includes the components and accessories necessary to deliver anesthesia. Gases and vaporizers The APAC System delivers three breathing circuit gases: O₂ (cylinder or pipeline) N₂O (pipeline only) air (pipeline only) The APAC System includes a Tec 5 Vaporizer Ventilators The APAC System uses a 7800 Ventilator changed to use O₂ or air as the pneumatic power source. Patient Safety Safety devices decrease the risk of: Hypoxic Mixtures A flow control proportioning system keeps the O₂ concentration higher than 23% at the fresh gas outlet for O₂ and N₂O mixtures. N₂O flow decreases proportionally as the O₂ supply decreases. N₂O and air flow stops completely in case of total O₂ supply failure. Complete power or sudden gas supply failures Batteries continue 7800 Ventilator operation during a power failure. Ohmeda ventilators have power failure alarms. Ohmeda ventilators have alarms for low gas supply pressure. The APAC System has an alarm for O₂ supply pressures less than 27 to 33 psig (186 to 228 kPa).

Source page: https://510kreport.com/device/K965041
Methodology: https://510kreport.com/methodology