Cleared Traditional

K954670 - PRESSORE MONITOR (FDA 510(k) Clearance)

Class I Physical Medicine device.

K954670 · Cleveland Medical Devices, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
20d
Days
Class 1
Risk

K954670 is an FDA 510(k) clearance for the PRESSORE MONITOR. Classified as Transducer, Miniature Pressure (product code IKE), Class I - General Controls.

Submitted by Cleveland Medical Devices, Inc. (Cleveland, US). The FDA issued a Cleared decision on October 30, 1995 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1615 - the FDA physical medicine 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 Cleveland Medical Devices, Inc. devices

Submission Details

510(k) Number K954670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1995
Decision Date October 30, 1995
Days to Decision 20 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IKE Transducer, Miniature Pressure
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1615
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.