Cleared Traditional

RION ELECTRO-PALATOGRAPH MODEL DP-01 (K802870) - FDA 510(k) Clearance

K802870 · Kindel & Anderson · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1980
Decision
33d
Days
-
Risk

K802870 is an FDA 510(k) clearance for the RION ELECTRO-PALATOGRAPH MODEL DP-01. Classified as Aids, Speech Training For The Hearing Impaired (ac-powered And Patient-contact) (product code LEZ).

Submitted by Kindel & Anderson (Mchenry, US). The FDA issued a Cleared decision on December 17, 1980 after a review of 33 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 Kindel & Anderson devices

Submission Details

510(k) Number K802870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1980
Decision Date December 17, 1980
Days to Decision 33 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
56d faster than avg
Panel avg: 89d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LEZ Aids, Speech Training For The Hearing Impaired (ac-powered And Patient-contact)
Device Class -