510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914978Substantially Equivalent

Oxyguard

Stantex Pty, Ltd., Sydney, New South Wales, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914978 is the FDA 510(k) clearance record for OXYGUARD, a class I device, cleared for Stantex Pty , Ltd. 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 one 510(k) clearance for Stantex Pty , Ltd. As of , FDA records show no recalls naming K914978.

Clearance record

Decision date
Received
(65 days to decision)
Product code
MNK Endoscopic Bite Block
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Stantex Pty , Ltd. 144 Great N. Rd., Five Dock, Sydney, New South Wales, AU
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