Cleared Traditional

K863546 - CPU GRAPH

K863546 is the FDA 510(k) clearance for CPU GRAPH by Ohmeda Medical. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K863546 · Ohmeda Medical · Anesthesiology device
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Sep 1986
Decision
6d
Days
Class 2
Risk

K863546 is an FDA 510(k) clearance for the CPU GRAPH. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Ohmeda Medical (Columbia, US). The FDA issued a Cleared decision on September 18, 1986 after a review of 6 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ohmeda Medical devices

Submission Details

510(k) Number K863546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1986
Decision Date September 18, 1986
Days to Decision 6 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
134d faster than avg
Panel avg: 140d · This submission: 6d
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 K863546.
PEDIATRIC BELLOWS
K864431 · Draeger Medical, Inc. · Jan 1987
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K864105 · Siemens Elema AB · Nov 1986
COMPANION 2500 PORTABLE VOLUME VENTILATOR
K862810 · Puritan Bennett Corp. · Sep 1986
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K862604 · Puritan Bennett Corp. · Aug 1986
MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR
K861707 · Siemens Elema AB · Jun 1986