DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS— 510(k) K023366

Name: FDA 510(k) clearance K023366
Creator: U.S. Food and Drug Administration
Published: 2003-10-07

Substantially Equivalent

Datex-Ohmeda, Inc.

FDA 510(k) clearance K023366 for DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS, Substantially Equivalent on 2003-10-07. Applicant: Datex-Ohmeda, Inc.. Device class: 2.

Clearance details

Applicant: Datex-Ohmeda, Inc.
Product code: Code CBK
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 2002-10-08
Decision date: 2003-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

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K232365 — Vivo 45 LS2025-12-19
K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A) +3 more2025-09-10

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K260326 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)2026-07-28
K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)2025-10-22
K213867 — Carestation 750/750c2023-03-28
K213551 — Giraffe Omnibed Carestation CS12022-03-02

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K023366

K-number listed on FDA's recall record

Z-0115-2020 — Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-000 g) 1006-9033-000 h) 1006-9117-000 i) 1006-9119-000 j) 1006-9030-000 k) 1006-9032-000 l) 1006-9022-000 m) To be provided n) 1006-9120-000 o) 1006-9027-000 p) 1006-9003-000 q) 1006-9025-000Class II·Terminated·GE Healthcare, LLC·20190719
Z-0678-2016 — GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures.Class II·Terminated·GE Medical Systems, LLC·20151215
Z-1787-2012 — GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.Class I·Terminated·GE Healthcare, LLC·20120410

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023366.

Data sourced from openFDA. This site is unofficial and independent of the FDA.