Cleared Traditional

TEACHER TM (K851655) - FDA 510(k) Clearance

K851655 · Monargue Intl. · Ear, Nose, Throat device
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Jun 1985
Decision
59d
Days
-
Risk

K851655 is an FDA 510(k) clearance for the TEACHER TM. Classified as Hearing Aid, Tactile (product code LRA).

Submitted by Monargue Intl. (Chatsworth, US). The FDA issued a Cleared decision on June 20, 1985 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat 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 Monargue Intl. devices

Submission Details

510(k) Number K851655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1985
Decision Date June 20, 1985
Days to Decision 59 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 89d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRA Hearing Aid, Tactile
Device Class -