Cleared Traditional

DYNAMIC PRESSURE MONITOR 2000M AND 2000C (K925258) - FDA 510(k) Clearance

Class I Physical Medicine device.

K925258 · Pin Dot Products, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
141d
Days
Class 1
Risk

K925258 is an FDA 510(k) clearance for the DYNAMIC PRESSURE MONITOR 2000M AND 2000C. Classified as System, Pressure Measurement, Intermittent (product code JFC), Class I - General Controls.

Submitted by Pin Dot Products, Inc. (Niles, US). The FDA issued a Cleared decision on March 9, 1993 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1600 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Pin Dot Products, Inc. devices

Submission Details

510(k) Number K925258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1992
Decision Date March 09, 1993
Days to Decision 141 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
26d slower than avg
Panel avg: 115d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JFC System, Pressure Measurement, Intermittent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1600
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.