# K946127: Ohmeda Excel Draw-Over Military Vaporizer System

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Oct 8, 1996 after 663 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
Longest line of descent: 1 generation back to K850648 (1985). 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)
- K863207: Ohmeda 'B' Series Gas Delivery System, Ohmeda Medical (1986) Summary page 1.
- K850648: Ohmeda Pac Portable Anesthesia System, Ohmeda Medical (1985). Our OCR of the scanned summary read K850848, FDA’s number for Brain Heart Infusion Agar (Micro Media Laboratories). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ohmeda PAC Portable Anesthesia Machine”.

## Cited in the summary but kept off the family tree
- K901117: Ohmeda Universal Pac, Ohmeda Medical (1990). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The purpose is to provide a platform for the delivery of inhalation anesthetic agents using the draw-over vaporizer and supplemental gas supply.

Source page: https://510kreport.com/device/K946127
Methodology: https://510kreport.com/methodology