# K993410: Dates-Ohmeda Aestiva Smartvent Mri

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Apr 25, 2000 after 196 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.
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) Datex-Ohmeda Aestiva 3000 Anesthesia System: named in the summary without a submission number
- (no number) Ohmeda Excel MRI Anesthesia System: named in the summary without a submission number

## Recalls of this device
- Apr 16, 2004 · Not classified · Z-0969-04: Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.

## Indications for use
The Aestiva SmarVent MRI provides the functional feature set offered by the conventional Aestiva 3000 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva 3000 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva SmartVent MRI performed to specifications when tested directly next to a 1.5 Tesla shielded MRI device in a field strength that did not exceed 300 gauss.

Source page: https://510kreport.com/device/K993410
Methodology: https://510kreport.com/methodology