Cleared Traditional

MODIFICATION 7200 MICROPROCESSOR VENTILATOR SYSTEM (K854070) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854070 · Puritan Bennett Corp. · Anesthesiology device
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Feb 1986
Decision
133d
Days
Class 2
Risk

K854070 is an FDA 510(k) clearance for the MODIFICATION 7200 MICROPROCESSOR VENTILATOR SYSTEM. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on February 14, 1986 after a review of 133 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 Puritan Bennett Corp. devices

Submission Details

510(k) Number K854070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1985
Decision Date February 14, 1986
Days to Decision 133 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 140d · This submission: 133d
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 73
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K854070.
CPU-1 INTENSIVE CARE VENTILATOR
K871398 · Ohmeda Medical · May 1987
OHMEDA 7400 ANESTHESIA VENTILATOR
K864129 · Ohmeda Medical · Dec 1986
CPU GRAPH
K863546 · Ohmeda Medical · Sep 1986
BABYBIRD 2 VENTILATOR
K820132 · 3M Company · Jan 1982
HEWLETT-PACKARD VENTILATOR
K810893 · Hewlett-Packard Co. · Jun 1981