VENTED/NON-VENTED GEMINI ADMINISTRATION SET— 510(k) K944320

Clearance details

Applicant

Imed Corp.

Product code

Code FPA

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

1994-08-29

Decision date

1995-02-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Diego, CA, US

• K254123 — Ecomed Disposable Administration Sets2026-09-11
• K261530 — iiSure Infusion Set2026-06-03
• K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)2026-05-04
• K251375 — PuraCath Firefly Needleless Connector IT (9005)2026-02-12
• K251257 — nSet+ Stabilization Set [6426733] +2 more2025-12-04

• K960512 — GEMINI PC-ITX1996-11-21
• K953896 — THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS1996-03-20
• K950153 — VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES1995-08-24
• K951922 — ADMINISTRATION SETS WITH BALL FLOAT1995-07-19
• K950419 — THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS1995-06-21

Death

95

Injury

14,421

Malfunction

125,815

Other

30

Total

140,361

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2459-2021 — BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion Buerette Set SmartSite Port (Burette) 3 SmartSite Y-Sites, REF: 10821753; BD Alaris Pump Infusion Buerette Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 11607787; BD Alaris Pump Infusion Buerette Set 0.2Micron Filter Ball Valve SmartSite Port (Burette) 2 SmartSite Y-Sites, REF: 11613191; BD Alaris Pump Infusion Buerette Set Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2440-0600; BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Site, REF: 2441-0007; BD Alaris Pump Infusion Buerette Set Low Sorbing Tubing Smartsite Port (Burette), REF: 2444-0007; BD Alaris Pump Infusion Buerette Set Ball Valve Smartsite Port (Burette) 2 Smartsite Y-Sites, REF: 2447-0007; BD Alaris Pump Infusion Set Back Check Valve 4-Way Stopcock 3 Smartsite Y-Sites Extension Set With SmartSite Port, REF: C24104EClass II·Ongoing·CAREFUSION·20210802
• Z-1179-2016 — Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007Class II·Terminated·CareFusion 303, Inc.·20160215
• Z-0445-2016 — Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.Class II·Terminated·CareFusion 303, Inc.·20151105
• Z-2025-2014 — SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458Class II·Terminated·CareFusion 303, Inc.·20140617
• Z-0435-2014 — VersaSafe Extension Set, Model No. 21000M-007Class II·Terminated·CareFusion 303, Inc.·20131108
• Z-0450-2014 — SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.Class II·Terminated·CareFusion 303, Inc.·20131108
• Z-2285-2013 — SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.Class II·Terminated·CareFusion 303, Inc.·20130830

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K944320.