# K962648: Ohmeda Model 5330 Anesthetic Agent Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Jan 17, 1997 after 193 days
- Product code: CBQ (Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration))
- Device class: 2
- Regulation: 21 CFR 868.1500
- 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 K890606 (1989). 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)
- K931439: Ohmeda Model 5330 Anesthetic Monitor, Ohmeda Medical (1993) Summary page 1.
- K890606: Ohmeda 5330 Agent Monitor, Ohmeda Medical (1989) Summary page 1.

## Cited in the summary but kept off the family tree
- X920590: Ohmeda Model 5250 RGM Monitor. Number could not be read Summary page 1.

## Indications for use
The Ohmeda Model 5330 Anesthetic Agent Monitor is intended for general hospital or clinical use by medical professionals whenever it is desired to monitor concentrations of anesthetic gas. The agents monitored include isoflurane, endoflurane, halothane, desflurane and sevoflurane. The need to monitor these anesthetic agents is most commonly encountered in the operating room during administration of anesthesia. It is available for sale only by or on the order of a licensed medical practitioner

Source page: https://510kreport.com/device/K962648
Methodology: https://510kreport.com/methodology