510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944049Substantially Equivalent

Oxygen Mouthguard

Endovations, Reading PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944049 is the FDA 510(k) clearance record for OXYGEN MOUTHGUARD, a class I device, cleared for Endovations, Inc. on under FDA product code MNK (Endoscopic Bite Block). FDA's definition for product code MNK reads: "To prevent patient from biting down in order to protect fragile endoscope equipment, patient's teeth and gums, and endscopist's fingers when inserting endoscope orally". FDA records list 38 510(k) clearances for Endovations, Inc., from to . As of , FDA records show no recalls naming K944049.

Clearance record

Decision date
Received
(54 days to decision)
Product code
MNK Endoscopic Bite Block
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Endovations, Inc. P.O. Box 6386, Reading PA
510(k) summary
Statement
Third party review
No

Clearances, product code MNK

Trailing 12 months

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

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