Cleared Traditional

SONIC PALPOMETER (K060125) - FDA 510(k) Clearance

Class I Physical Medicine device.

K060125 · Palpometer Systems, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
57d
Days
Class 1
Risk

K060125 is an FDA 510(k) clearance for the SONIC PALPOMETER. Classified as Transducer, Miniature Pressure (product code IKE), Class I - General Controls.

Submitted by Palpometer Systems, Inc. (Victoria, British Columbia, CA). The FDA issued a Cleared decision on March 16, 2006 after a review of 57 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 Palpometer Systems, Inc. devices

Submission Details

510(k) Number K060125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2006
Decision Date March 16, 2006
Days to Decision 57 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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.