510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911795Substantially Equivalent

Kinesthetic Ability Trainer (K.a.t., Model 1000)

Breg, Inc., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911795 is the FDA 510(k) clearance record for KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000), cleared for Breg, Inc. on under FDA product code LXV (Apparatus, Vestibular Analysis). FDA records list 4 510(k) clearances for Breg, Inc., from to . As of , FDA records show no recalls naming K911795.

Clearance record

Decision date
Received
(211 days to decision)
Product code
LXV Apparatus, Vestibular Analysis
Device class
Unclassified
Review panel
Unknown
Applicant
Breg, Inc. 344 22nd St., Costa Mesa CA
510(k) summary
Statement
Third party review
No

Clearances, product code LXV

Trailing 12 months

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

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