Cleared Traditional

K822560 - IRRIGATION SET (FDA 510(k) Clearance)

Class I Orthopedic device.

K822560 · Utah Medical Products, Inc. · Orthopedic device
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Dec 1982
Decision
101d
Days
Class 1
Risk

K822560 is an FDA 510(k) clearance for the IRRIGATION SET. Classified as Accessories, Arthroscopic (product code NBH), Class I - General Controls.

Submitted by Utah Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on December 3, 1982 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Utah Medical Products, Inc. devices

Submission Details

510(k) Number K822560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1982
Decision Date December 03, 1982
Days to Decision 101 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 122d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NBH Accessories, Arthroscopic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1100
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.