510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K910177Substantially Equivalent

Seal-Rite Silicone Ear Plug

Flents Products Co., Inc., Norwalk CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910177 is the FDA 510(k) clearance record for SEAL-RITE SILICONE EAR PLUG, cleared for Flents Products Co., Inc. on under FDA product code EWD (Protector, Hearing (Insert)). FDA records list 2 510(k) clearances for Flents Products Co., Inc., from to . As of , FDA records show no recalls naming K910177.

Clearance record

Decision date
Received
(160 days to decision)
Product code
EWD Protector, Hearing (Insert)
Device class
Unclassified
Review panel
Unknown
Applicant
Flents Products Co., Inc. P.O. Box 2109, Norwalk CT
Third party review
No

Clearances, product code EWD

Trailing 12 months

FDA records hold no clearances under product code EWD in the trailing twelve months.

FDA records show no clearances under product code EWD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EWD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260