Cleared Traditional

K851509 - OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR

K851509 is an FDA 510(k) clearance for OHMEDA 7000 ELECTRONIC ANESTHESIA VENTI..., manufactured by Ohmeda Medical. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K851509 · Ohmeda Medical · Anesthesiology device
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Jul 1985
Decision
91d
Days
Class 2
Risk

K851509 is an FDA 510(k) clearance for the OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on July 15, 1985 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ohmeda Medical devices

FDA 510(k) Submission Details - K851509

510(k) Number K851509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1985
Decision Date July 15, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 140d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 366
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K851509.
ADULT VENTILATOR TESTER VT-1
K853760 · Bio-Tek Instruments, Inc. · Dec 1985
PC INTERFACE
K852771 · Siemens Elema AB · Oct 1985
HEALTHDYNE IMPLUSE VENTILATOR
K853300 · Healthdyne, Inc. · Aug 1985
CONNECTION CABLE FOR SYNCHRONIZATION OF TWO SERVO
K850374 · Siemens Elema AB · Apr 1985
SERVO VENTILATOR 900D SIEMENS-ELEMA AB
K844912 · Siemens Elema AB · Dec 1984
NEWPORT VENTILATOR MODEL E-100
K844350 · Newport Medical Instruments, Inc. · Dec 1984