510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K832852Substantially Equivalent

Blaise-Rathael Voice Prosthesis

Richards Medical Co., Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832852 is the FDA 510(k) clearance record for BLAISE-RATHAEL VOICE PROSTHESIS, a class II device, cleared for Richards Medical Co., Inc. on under FDA product code EWL (Prosthesis, Laryngeal (Taub)). FDA records list 71 510(k) clearances for Richards Medical Co., Inc., from to . As of , FDA records show no recalls naming K832852.

Clearance record

Decision date
Received
(44 days to decision)
Product code
EWL Prosthesis, Laryngeal (Taub)
Regulation
21 CFR 874.3730
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Richards Medical Co., Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code EWL

Trailing 12 months

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

FDA records show no clearances under product code EWL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EWL, 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