Cleared Traditional

K910177 - SEAL-RITE SILICONE EAR PLUG

K910177 · Flents Products Co., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K910177

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.

EWD Device Classification - Class 0,

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