Cleared Traditional

R1618, R1619 & R1654 ICE MAKING MACHINES (K861343) - FDA 510(k) Clearance

K861343 · Tri W-G, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1986
Decision
101d
Days
-
Risk

K861343 is an FDA 510(k) clearance for the R1618, R1619 & R1654 ICE MAKING MACHINES.

Submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on July 17, 1986 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel. 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 Tri W-G, Inc. devices

Submission Details

510(k) Number K861343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1986
Decision Date July 17, 1986
Days to Decision 101 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 115d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -