Cleared Traditional

K851509 - OHMEDA 7000 ELECTRONIC ANESTHESIA VENTI...

K851509 is the FDA 510(k) clearance for OHMEDA 7000 ELECTRONIC ANESTHESIA VENTI... by Ohmeda Medical. It is a Class 2 Anesthesiology device (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

Submission Details

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.

Device Classification

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 196
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
POWER PACK 160 SIEMENS-ELEMA AB
K844590 · Siemens Elema AB · Nov 1984