Cleared Traditional

K822560 - IRRIGATION SET

K822560 is an FDA 510(k) clearance for IRRIGATION SET, manufactured by Utah Medical Products, Inc.. The device is a Class 1 Orthopedic device with product code NBH cleared through the Traditional 510(k) pathway after a 101-day FDA review.

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

FDA 510(k) Submission Details - K822560

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 122d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

NBH Device Classification - Class 1, General Controls

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.