Cleared Traditional

OHMEDA CPU MONITOR (K852504) - FDA 510(k) Clearance

K852504 · Ohmeda Medical · Cardiovascular device
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Jul 1985
Decision
19d
Days
-
Risk

K852504 is an FDA 510(k) clearance for the OHMEDA CPU MONITOR.

Submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on July 1, 1985 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel. 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.

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Submission Details

510(k) Number K852504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1985
Decision Date July 01, 1985
Days to Decision 19 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 125d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -