510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863753Substantially Equivalent

Foundations Plus Double Band Ear Support 3000

Foundations Plus, Inc., Colleyville TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863753 is the FDA 510(k) clearance record for FOUNDATIONS PLUS DOUBLE BAND EAR SUPPORT 3000, a class I device, cleared for Foundations Plus, Inc. on under FDA product code KGX (Tape And Bandage, Adhesive). FDA records list 4 510(k) clearances for Foundations Plus, Inc., from to . As of , FDA records show no recalls naming K863753.

Clearance record

Decision date
Received
(35 days to decision)
Product code
KGX Tape And Bandage, Adhesive
Regulation
21 CFR 880.5240
Device class
Class I
Review panel
General Hospital
Applicant
Foundations Plus, Inc. 1008 Tinker Rd., Colleyville TX
Third party review
No

Clearances, product code KGX

Trailing 12 months

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

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