510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K844309Substantially Equivalent

IV Ratemeter

Aci Medical, LLC, Sunland CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844309 is the FDA 510(k) clearance record for IV RATEMETER, a class II device, cleared for Aci Medical, Inc. on under FDA product code FLN (Monitor, Electric For Gravity Flow Infusion Systems). FDA records list 7 510(k) clearances for Aci Medical, Inc., from to . As of , FDA records show no recalls naming K844309.

Clearance record

Decision date
Received
(77 days to decision)
Product code
FLN Monitor, Electric For Gravity Flow Infusion Systems
Regulation
21 CFR 880.2420
Device class
Class II
Review panel
General Hospital
Applicant
Aci Medical, Inc. 8835 Mulberry Dr., Sunland CA
Third party review
No

Clearances, product code FLN

Trailing 12 months

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

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