Cleared Traditional

K800760 - BITE BLOCK SYSTEM (FDA 510(k) Clearance)

K800760 · Radiation Products Design, Inc. · Neurology device
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May 1980
Decision
54d
Days
-
Risk

K800760 is an FDA 510(k) clearance for the BITE BLOCK SYSTEM.

Submitted by Radiation Products Design, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1980 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Neurology 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 Radiation Products Design, Inc. devices

Submission Details

510(k) Number K800760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1980
Decision Date May 28, 1980
Days to Decision 54 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 148d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -