# K000706: Datex-Ohmeda Aestiva/5 with 7100 Ventilator

- Pathway: 510(k) (Special)
- Applicant: Datex-Ohmeda, Inc.
- Decided: May 11, 2000 after 70 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
158 later devices descend from it; 4 cite it directly.
46 of 159 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013642: AVEA (2002), 133 descendants of its own
- K032451: Bird Tbird Vela Ventilator (2004), 114 descendants of its own
- K052554: Modification to: Ivent 201 Portable Ventilator (2005), 112 descendants of its own
- K053270: IVENT 201 (2006), 87 descendants of its own
- K061627: Modification to I Vent 201 (2006), 86 descendants of its own

## Recalls of this device
- Jul 19, 2019 · Class II · Z-0116-2020: Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opp
- Jul 19, 2019 · Class II · Z-0117-2020: Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opp
- Sep 27, 2005 · Not classified · Z-0037-06: Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may n
- Apr 16, 2004 · Not classified · Z-0968-04: Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.

Source page: https://510kreport.com/device/K000706
Methodology: https://510kreport.com/methodology