Cleared Traditional

SEAL-RITE SILICONE EAR PLUG (K910177) - FDA 510(k) Clearance

K910177 · Flents Products Co., Inc. · Ear, Nose, Throat device
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Jun 1991
Decision
160d
Days
-
Risk

K910177 is an FDA 510(k) clearance for the SEAL-RITE SILICONE EAR PLUG. Classified as Protector, Hearing (insert) (product code EWD).

Submitted by Flents Products Co., Inc. (Norwalk, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 160 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Flents Products Co., Inc. devices

Submission Details

510(k) Number K910177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1991
Decision Date June 24, 1991
Days to Decision 160 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
71d slower than avg
Panel avg: 89d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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