510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212530Substantially Equivalent

IVX Fluid Transfer Set

Omnicell, Inc., Cranberry PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212530 is the FDA 510(k) clearance record for IVX Fluid Transfer Set, a class II device, cleared for Omnicell, Inc. on under FDA product code LHI (Set, I.V. Fluid Transfer). FDA records list one 510(k) clearance for Omnicell, Inc. As of , FDA records show one recall naming K212530.

Clearance record

Decision date
Received
(256 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
Omnicell, Inc. 500 Cranberry Woods Dr., Cranberry PA
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