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
K052594Substantially Equivalent

Willcare, Model Gw-1020

Abbott Medical, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052594 is the FDA 510(k) clearance record for WILLCARE, MODEL GW-1020, a class II device, cleared for Icu Medical, Inc. on under FDA product code FRN (Pump, Infusion). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K052594.

Clearance record

Decision date
Received
(142 days to decision)
Product code
FRN Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Icu Medical, Inc. 16787 Bernardo Center Dr.,, San Diego CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code FRN

Trailing 12 months
2 clearances under product code FRN in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FRN, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260