# K081447: Fourth Gas Module with CO2 for Primus US Apollo

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical AG & Co. KG
- Decided: Oct 8, 2008 after 139 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
Longest line of descent: 1 generation back to K973896 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000706: Datex-Ohmeda Aestiva/5 with 7100 Ventilator, Datex-Ohmeda, Inc. (2000) Summary page 2.
- K973896: Ohmeda Excel 3000 Anesthesia System, Ohmeda Medical (1998) Summary page 2.

## Recalls of this device
- May 24, 2018 · Class II · Z-2253-2018: The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to t

## Indications for use
The Primus US "Apollo" is indicated as a continuous flow anesthesia system. The Primus US "Apollo" may be used for manually assisted, or automatic ventilation, and delivery of gases (02, N 2 0 and CO 2 - in combination with the CO 2 module [i.e. Fourth Gas Module]), anesthetic vapor, and monitoring of oxygen and CO 2 concentrations, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K081447
Methodology: https://510kreport.com/methodology