Cleared Traditional

K981428 - ANU ICE

K981428 · Cryoptherapy Pain Relief Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
78d
Days
-
Risk

K981428 is an FDA 510(k) clearance for the ANU ICE. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by Cryoptherapy Pain Relief Products, Inc. (Pembroke Pines, US). The FDA issued a Cleared decision on July 7, 1998 after a review of 78 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 Cryoptherapy Pain Relief Products, Inc. devices

FDA 510(k) Submission Details - K981428

510(k) Number K981428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1998
Decision Date July 07, 1998
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 131d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

LKX Device Classification - Class 0,

Product Code LKX Device, Thermal, Hemorrhoids
Device Class -

Regulatory Peers - LKX Device, Thermal, Hemorrhoids

All 7
Devices cleared under the same product code (LKX) and FDA review panel - the closest regulatory comparables to K981428.
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HEMORRELIEF DEVICE
K973590 · A.Stein - Regulatory Affairs Consulting · Feb 1998
THERMOTHERAPY
K822217 · Luther Medical Products, Inc. · Sep 1982