Cleared Traditional

K060125 - SONIC PALPOMETER

K060125 is an FDA 510(k) clearance for SONIC PALPOMETER, manufactured by Palpometer Systems, Inc.. The device is a Class 1 Physical Medicine device with product code IKE cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K060125 · Palpometer Systems, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K060125

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 116d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

IKE Device Classification - Class 1, General Controls

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.

Regulatory Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IKE Transducer, Miniature Pressure

All 14
Devices cleared under the same product code (IKE) and FDA review panel - the closest regulatory comparables to K060125.
PRESSORE MONITOR
K954670 · Cleveland Medical Devices, Inc. · Oct 1995
THE EQUALIZER
K915369 · Advanced Rehabilitative Technology, Inc. · Mar 1993
PORTABLE LIMB LOAD MONITOR (BMLLM-100)
K915326 · Bar Med Pty , Ltd. · Oct 1992
IOWA ORAL PERFORMANCE ISNTRUMENT
K920091 · Breakthrough, Inc. · May 1992
FPL
K915897 · Wrm Computers · Apr 1992
TALLEY SD.500 SKIN PRESSURE EVALUATOR
K914780 · Talley Group, Ltd. · Dec 1991

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K060125 · SONIC PALPOMETER
Download PDF FDA Summary Palpometer Systems, I…