510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220514Substantially Equivalent

bite away neo

Mibetec GmbH, Brehna, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220514 is the FDA 510(k) clearance record for bite away neo, a class II device, cleared for mibeTec GmbH on under FDA product code IRT (Pad, Heating, Powered). FDA records list 2 510(k) clearances for mibeTec GmbH, from to . As of , FDA records show no recalls naming K220514.

Clearance record

Decision date
Received
(121 days to decision)
Product code
IRT Pad, Heating, Powered
Regulation
21 CFR 890.5740
Device class
Class II
Review panel
Physical Medicine
Applicant
mibeTec GmbH Munchener Strasse 15, Brehna, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IRT

Trailing 12 months

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

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