510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K915409Substantially Equivalent

Intraosseous Access Needle

Cook Inc., Bloomington IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915409 is the FDA 510(k) clearance record for INTRAOSSEOUS ACCESS NEEDLE, a class II device, cleared for Cook, Inc. on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list 163 510(k) clearances for Cook, Inc., from to . As of , FDA records show no recalls naming K915409.

Clearance record

Decision date
Received
(93 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Cook, Inc. 925 S. Curry Pike, Bloomington IN
510(k) summary
Statement
Third party review
No

Clearances, product code FMI

Trailing 12 months
12 clearances under product code FMI in the twelve months to November 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FMI, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20263
April 20261
May 20260
June 20261
July 20262
August 20263
September 20261
October 20260
November 20260