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
K790382Substantially Equivalent

Coil Dialysis, Models Dm-360 and Dm-360-

Estracorporeal, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790382 is the FDA 510(k) clearance record for COIL DIALYSIS, MODELS DM-360 AND DM-360-, a class II device, cleared for Estracorporeal, Inc. on under FDA product code FKD (Canister, Coil). FDA records list 2 510(k) clearances for Estracorporeal, Inc., from to . As of , FDA records show no recalls naming K790382.

Clearance record

Decision date
Received
(64 days to decision)
Product code
FKD Canister, Coil
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Estracorporeal, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FKD

Trailing 12 months

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

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