510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K201877Substantially Equivalent

OtoSet- Ear Cleaning System

Safkan, Inc., Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201877 is the FDA 510(k) clearance record for OtoSet- Ear Cleaning System, a class I device, cleared for Safkan, Inc. on under FDA product code KYZ (Syringe, Irrigating (Non Dental)). FDA records list one 510(k) clearance for Safkan, Inc. As of , FDA records show no recalls naming K201877.

Clearance record

Decision date
Received
(121 days to decision)
Product code
KYZ Syringe, Irrigating (Non Dental)
Regulation
21 CFR 880.6960
Device class
Class I
Review panel
General Hospital
Applicant
Safkan, Inc. 1665 E 18th St. #205, Tucson AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KYZ

Trailing 12 months

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

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