510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945537Substantially Equivalent

T-Guard

Med et AL Development, Matthews NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945537 is the FDA 510(k) clearance record for T-GUARD, a class I device, cleared for Med ET AL Development on under FDA product code LQX (Device, Finger-Sucking). FDA records list one 510(k) clearance for Med ET AL Development. As of , FDA records show no recalls naming K945537.

Clearance record

Decision date
Received
(129 days to decision)
Product code
LQX Device, Finger-Sucking
Regulation
21 CFR 890.3475
Device class
Class I
Review panel
Physical Medicine
Applicant
Med ET AL Development 815 Tadlock Pl., Matthews NC
510(k) summary
Statement
Third party review
No

Clearances, product code LQX

Trailing 12 months

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

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