510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883416Substantially Equivalent

Mouthpiece Breathing (Performance Mouthguard)

Scott All-Sports, Inc., West Monroe LA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883416 is the FDA 510(k) clearance record for MOUTHPIECE BREATHING (PERFORMANCE MOUTHGUARD), a class II device, cleared for Scott All-Sports, Inc. on under FDA product code JXL (Block, Bite). FDA records list 2 510(k) clearances for Scott All-Sports, Inc., from to . As of , FDA records show no recalls naming K883416.

Clearance record

Decision date
Received
(58 days to decision)
Product code
JXL Block, Bite
Regulation
21 CFR 882.5070
Device class
Class II
Review panel
Neurology
Applicant
Scott All-Sports, Inc. 120 Professional Dr., West Monroe LA
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