510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844904Substantially Equivalent

Cytosafe Needle

Baxa Corp., Sub. of Cook Group, Inc., Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844904 is the FDA 510(k) clearance record for CYTOSAFE NEEDLE, a class II device, cleared for Baxa Corp., Sub. of Cook Group, Inc. on under FDA product code LHI (Set, I.V. Fluid Transfer). FDA records list 16 510(k) clearances for Baxa Corp., Sub. of Cook Group, Inc., from to . As of , FDA records show no recalls naming K844904.

Clearance record

Decision date
Received
(67 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
Baxa Corp., Sub. of Cook Group, Inc. P.O. Box 9327, Denver CO
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