510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243404Substantially Equivalent

HyHub™ and HyHub™ Duo Vial Access Devices

Takeda Pharmaceuticals, Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243404 is the FDA 510(k) clearance record for HyHub™ and HyHub™ Duo Vial Access Devices, a class II device, cleared for Takeda Pharmaceuticals on under FDA product code LHI (Set, I.V. Fluid Transfer). FDA records list one 510(k) clearance for Takeda Pharmaceuticals. As of , FDA records show no recalls naming K243404.

Clearance record

Decision date
Received
(259 days to decision)
Product code
LHI Set, I.V. Fluid Transfer
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Takeda Pharmaceuticals 500 Kendall St., Cambridge MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LHI

Trailing 12 months
2 clearances under product code LHI in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LHI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260