510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K984313Substantially Equivalent

Htu3

Hyox Systems, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984313 is the FDA 510(k) clearance record for HTU3, a class II device, cleared for Hyox Systems , Ltd. on under FDA product code CBF (Chamber, Hyperbaric). FDA records list one 510(k) clearance for Hyox Systems , Ltd. As of , FDA records show no recalls naming K984313.

Clearance record

Decision date
Received
(324 days to decision)
Product code
CBF Chamber, Hyperbaric
Regulation
21 CFR 868.5470
Device class
Class II
Review panel
Anesthesiology
Applicant
Hyox Systems , Ltd. 555 Thirteenth St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code CBF

Trailing 12 months

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

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