Cleared Traditional

HEARING AIDS MODELS IMS, ISD, ICL & IHX (K844478) - FDA 510(k) Clearance

K844478 · The Ite Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
101d
Days
-
Risk

K844478 is an FDA 510(k) clearance for the HEARING AIDS MODELS IMS, ISD, ICL & IHX.

Submitted by The Ite Co. (Seal Beach, US). The FDA issued a Cleared decision on February 28, 1985 after a review of 101 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all The Ite Co. devices

Submission Details

510(k) Number K844478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1984
Decision Date February 28, 1985
Days to Decision 101 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
29d faster than avg
Panel avg: 130d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -