Cleared Traditional

BILSOM PROPP (K791608) - FDA 510(k) Clearance

K791608 · Bilson International, Inc. · Ear, Nose, Throat device
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Oct 1979
Decision
58d
Days
-
Risk

K791608 is an FDA 510(k) clearance for the BILSOM PROPP. Classified as Protector, Hearing (insert) (product code EWD).

Submitted by Bilson International, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1979 after a review of 58 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 Bilson International, Inc. devices

Submission Details

510(k) Number K791608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1979
Decision Date October 10, 1979
Days to Decision 58 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
31d faster than avg
Panel avg: 89d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EWD Protector, Hearing (insert)
Device Class -