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
K141193Substantially Equivalent

Medfusion 4000 Pump Device Specific Reports Solfware for Pharmguard Server Version 2.0

Abbott Medical, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141193 is the FDA 510(k) clearance record for MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0, a class II device, cleared for Smiths Medical Asd, Inc. on under FDA product code PHC (Infusion Safety Management Software). FDA's definition for product code PHC reads: "Infusion safety management software is a prescription device intended for use with infusion pumps and may include one or more of the following capabilities: prepopulation of infusion programming parameters, data retrieval and analysis for...". FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K141193.

Clearance record

Decision date
Received
(78 days to decision)
Product code
PHC Infusion Safety Management Software
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Smiths Medical Asd, Inc. 1265 Grey Fox Rd., St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHC

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