Cleared Traditional

HEMOR-ICE (K854569) - FDA 510(k) Clearance

K854569 · Technology 2000 · Gastroenterology & Urology device
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Feb 1986
Decision
83d
Days
-
Risk

K854569 is an FDA 510(k) clearance for the HEMOR-ICE. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by Technology 2000 (Lakewood, US). The FDA issued a Cleared decision on February 5, 1986 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Technology 2000 devices

Submission Details

510(k) Number K854569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1985
Decision Date February 05, 1986
Days to Decision 83 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 130d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKX Device, Thermal, Hemorrhoids
Device Class -