Cleared Traditional

K925066 - PNEUMATIC IRRIGATION STANDARD (FDA 510(k) Clearance)

Class I General Hospital device.

K925066 · Arthrodyn, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
295d
Days
Class 1
Risk

K925066 is an FDA 510(k) clearance for the PNEUMATIC IRRIGATION STANDARD. Classified as Stand, Infusion (product code FOX), Class I - General Controls.

Submitted by Arthrodyn, Inc. (Madison, US). The FDA issued a Cleared decision on July 28, 1993 after a review of 295 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6990 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthrodyn, Inc. devices

Submission Details

510(k) Number K925066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1992
Decision Date July 28, 1993
Days to Decision 295 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 128d · This submission: 295d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FOX Stand, Infusion
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6990
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.