510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890567Substantially Equivalent

Bite Block #59430

Medi-Source, Inc., Syosset NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890567 is the FDA 510(k) clearance record for BITE BLOCK #59430, a class II device, cleared for Medi-Source, Inc. on under FDA product code JXL (Block, Bite). FDA records list 4 510(k) clearances for Medi-Source, Inc., from to . As of , FDA records show no recalls naming K890567.

Clearance record

Decision date
Received
(11 days to decision)
Product code
JXL Block, Bite
Regulation
21 CFR 882.5070
Device class
Class II
Review panel
Neurology
Applicant
Medi-Source, Inc. 50 Gordon Dr., Syosset NY
Third party review
No

Clearances, product code JXL

Trailing 12 months

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

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