510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895274Substantially Equivalent

Hypex

Global Business, Inc., Midlothian VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895274 is the FDA 510(k) clearance record for HYPEX, a class I device, cleared for Global Business, Inc. on under FDA product code BYW (Device, Rebreathing). FDA records list one 510(k) clearance for Global Business, Inc. As of , FDA records show no recalls naming K895274.

Clearance record

Decision date
Received
(184 days to decision)
Product code
BYW Device, Rebreathing
Regulation
21 CFR 868.5675
Device class
Class I
Review panel
Anesthesiology
Applicant
Global Business, Inc. 2121 Castlebridge Rd., Midlothian VA
Third party review
No

Clearances, product code BYW

Trailing 12 months

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

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