Cleared Traditional

THERMOTHERAPY (K822217) - FDA 510(k) Clearance

K822217 · Luther Medical Products, Inc. · Gastroenterology & Urology device
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Sep 1982
Decision
60d
Days
-
Risk

K822217 is an FDA 510(k) clearance for the THERMOTHERAPY. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by Luther Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1982 after a review of 60 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 Luther Medical Products, Inc. devices

Submission Details

510(k) Number K822217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1982
Decision Date September 24, 1982
Days to Decision 60 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
70d faster than avg
Panel avg: 130d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKX Device, Thermal, Hemorrhoids
Device Class -