510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K903143Substantially Equivalent

Otoscreener-I and Oto-Screen-I-P

Handtronix, Inc., Sandy UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903143 is the FDA 510(k) clearance record for OTOSCREENER-I AND OTO-SCREEN-I-P, a class II device, cleared for Handtronix, Inc. on under FDA product code EWO (Audiometer). FDA records list one 510(k) clearance for Handtronix, Inc. As of , FDA records show no recalls naming K903143.

Clearance record

Decision date
Received
(63 days to decision)
Product code
EWO Audiometer
Regulation
21 CFR 874.1050
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Handtronix, Inc. 2435 Falcon Way, Sandy UT
Third party review
No

Clearances, product code EWO

Trailing 12 months

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

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