510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822348Substantially Equivalent

Tytan Tube Inserter

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

K822348 is the FDA 510(k) clearance record for TYTAN TUBE INSERTER, a class I device, cleared for Treace Medical, Inc. on under FDA product code JYM (Inserter, Myringotomy Tube). FDA records list 80 510(k) clearances for Treace Medical, Inc., from to . As of , FDA records show no recalls naming K822348.

Clearance record

Decision date
Received
(32 days to decision)
Product code
JYM Inserter, Myringotomy Tube
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Treace Medical, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JYM

Trailing 12 months

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

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