Company · US
Medex, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2025. Name variants (Inc, Corp, punctuation) are merged.
50510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FPA | Set, Administration, Intravascular | 9 |
| DRS | Transducer, Blood-Pressure, Extravascular | 7 |
| FRN | Pump, Infusion | 6 |
| FMG | Stopcock, I.V. Set | 4 |
| DQO | Catheter, Intravascular, Diagnostic | 3 |
| GWM | Device, Monitoring, Intracranial Pressure | 3 |
| KRA | Catheter, Continuous Flush | 3 |
| KXO | Monitor, Pressure, Intrauterine | 3 |
| BYH | Drain, Tee (Water Trap) | 2 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 2 |
| CAJ | 2 | |
| FMF | Syringe, Piston | 2 |
| FPB | Filter, Infusion Line | 2 |
| KGB | Mask, Oxygen, Non-Rebreathing | 2 |
| KRK | Manometer, Blood-Pressure, Venous | 2 |
| MAV | Syringe, Balloon Inflation | 2 |
| DPT | Probe, Blood-Flow, Extravascular | 1 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 29, 2025 | K242255 | Qitexio® 4-Way Stopcock (QIT014) Medex, FR | FMG |
| Mar 14, 2022 | K203738 | Qitexio Medex, FR | FMF |
| Jan 4, 2005 | K042432 | PHARMGUARD TOOLBOX, MODEL G6000782 Medex, Inc. | FRN |
| Apr 30, 2004 | K040899 | MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP Medex, Inc. | FRN |
| May 20, 2002 | K020780 | TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP Medex, Inc. | GWM |
| May 9, 2000 | K000328 | MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP Medex, Inc. | FRN |
| Apr 6, 1999 | K982640 | MEDEX 3000 SERIES SYRINGE INFUSION PUMP Medex, Inc. | FRN |
| Jul 21, 1998 | K982123 | CONTRAST CONTROL DEVICE Medex, Inc. | FPA |
| Jul 18, 1996 | K955231 | MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP Medex, Inc. | FRN |
| Jun 27, 1996 | K961404 | MX960 REUSABLE PRESSURE TRANSDUCER Medex, Inc. | DRS |
| Jun 6, 1996 | K961527 | MX703 AND MX730 CONTINUOUS FLUSH DEVICES Medex, Inc. | KRA |
| Apr 22, 1996 | K954970 | STOPCOCK & LUER LOCK PLUG Medex, Inc. | FMG |
| Sep 21, 1995 | K952160 | INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA) Medex, Inc. | FPA |
| Apr 5, 1995 | K951129 | NOVATRANS II Medex, Inc. | DRS |
| Feb 10, 1995 | K943897 | NU-SITE Medex, Inc. | FPA |
| Dec 13, 1994 | K944208 | IV ADMINISTRATION SET FPA Medex, Inc. | FPA |
| Aug 16, 1994 | K942377 | TRANSTAR PRESSURE TRANSDUCER Medex, Inc. | DPT |
| Aug 11, 1994 | K940896 | MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE Medex, Inc. | MAV |
| Jun 14, 1994 | K922323 | MX4042/MC4044 SERIES SIMULCATH(TM) Medex, Inc. | KXO |
| Nov 27, 1991 | K913498 | MX927 BLOOD TRANSFER DEVICE Medex, Inc. | FMI |
| Sep 11, 1991 | K912709 | MX 339 TWIN HEMOSTATIC Y CONNECTOR Medex, Inc. | DTL |
| Jul 12, 1991 | K910958 | MEDFLATOR INFLATION SYSTEM Medex, Inc. | MAV |
| Apr 3, 1991 | K910227 | MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER Medex, Inc. | KXO |
| Dec 27, 1990 | K904674 | CENTRAL VENOUS PRESSURE MANOMETER Medex, Inc. | KRK |
| Dec 17, 1990 | K903199 | HOLLOW LUMEN NEEDLE, PART NUMBER: MX920 Medex, Inc. | DQO |
| Nov 5, 1990 | K902771 | ARTERIAL BLOOD SAMPLING KIT Medex, Inc. | DQO |
| Sep 12, 1988 | K883095 | MX860, REUSABLE PRESSURE TRANSDUCER Medex, Inc. | DRS |
| Aug 10, 1988 | K883094 | MX350 (SERIES) CONTROL SYRINGE Medex, Inc. | FMF |
| Jun 15, 1988 | K880696 | MX1002 CABLE-CAL TM Medex, Inc. | DXG |
| Feb 11, 1988 | K880032 | MEDEX MACHINE Medex, Inc. | ISD |
| Jan 14, 1988 | K874133 | MX710 SERIES VASCULAR ACCESS INFUSION SET Medex, Inc. | FPA |
| Sep 4, 1987 | K872795 | CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE Medex, Inc. | FPA |
| May 6, 1987 | K870301 | MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER Medex, Inc. | DRS |
| Apr 14, 1986 | K860101 | MX4040 INTRAUTERINE PRESSURE MONITORING KIT Medex, Inc. | KXO |
| Jan 16, 1986 | K853814 | MP0400 ADULT, PERISTALIC INFUSION PUMP Medex, Inc. | FRN |
| Feb 20, 1985 | K844631 | PERIFLUX PF-2 Medex, Inc. | DPW |
| Feb 9, 1983 | K830152 | MINILOOP I.V. CONNECTORS & ADAPTOR Medex, Inc. | FPA |
| Feb 7, 1983 | K830178 | MINILOOP DISPOS. IV CONNECTORS ADAPT. Medex, Inc. | FPA |
| Nov 16, 1982 | K822864 | INTRACRANIAL PRESSURE MONITORING DEVICE Medex, Inc. | GWM |
| Mar 4, 1982 | K820355 | DISPOSABLE DIAPHRAGM DOMES Medex, Inc. | DRS |
| Feb 19, 1981 | K810009 | DISPOSABLE DIAPHRAGM DOME Medex, Inc. | DRS |
| Apr 29, 1980 | K800560 | MX820-5 PRESSURE INFUSOR 500CC MX820-10 Medex, Inc. | KZD |
| Dec 20, 1979 | K792510 | MICROBAR MONITORING LINE FILTER Medex, Inc. | FPB |
| May 16, 1979 | K790407 | MICROTEC BACTERIAL FILTER Medex, Inc. | DRS |
| Apr 30, 1979 | K790408 | T-CONNECTOR Medex, Inc. | FPA |
| Mar 23, 1979 | K790455 | MICROFLUSH Medex, Inc. | KRA |
| Mar 6, 1979 | K790314 | FLUID ADMINISTRATION SETS, 15 MICRON Medex, Inc. | FPB |
| Feb 22, 1979 | K782168 | 3-WAY STOPCOCK Medex, Inc. | FMG |
| Feb 21, 1979 | K782167 | DELTA FLOW Medex, Inc. | FMG |
| Mar 16, 1977 | K770432 | MICROFLUSH Medex, Inc. | KRA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2006 | Medex Inc MX441B, CVP Manometer. The product is packaged in a cardboard box. The units are packed ten (10) per case. The product is labeled on the outer case with a stick-on label that reads in part, ''**mede Terminated |
KRK | K904674 |
| Apr 26, 2006 | Medex Inc MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch wit Terminated |
GWM | K822864 |
| Nov 16, 2004 | Medex Inc MX20170: Pediatric 40 In Sampling Kit w/10cc syringe,
MX20443: LogiCal Single Pressure Kit,
MX20470: Pressure Monitoring Kit,
MX20477: LogiCal Double Kit,
MX20730: Double LogiCal Kit,
MX20760: Neonata Terminated |
DQO | K902771 |
| Jul 22, 2004 | Medex Inc Disposable Oxygen Mask & Bag, Adult Non-Rebreathing Mask w/Safety Vent and 84'' Tube; reorder no. 7022; SIngle Patient Only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Terminated |
KGB | None listed |
| Jul 22, 2004 | Medex Inc Disposable Oxygen Mask & Bag, a High Concentration Non-Rebreathing Mask, complete w/Bag and One Way Valves, w/84'' Tube (3 in 1 mask); reorder no. 7020; SIngle Patient Only; IPI label - Manufactured Terminated |
KGB | None listed |
| Jul 22, 2004 | Medex Inc Disposable Water Trap with ''Y'' for Ventilator Circuits; product reorder 6091; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Terminated |
BYH | None listed |
| Jul 22, 2004 | Medex Inc Disposable Water Trap with ''T'' for Ventilator Circuits; product reorder 6090; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Terminated |
BYH | None listed |
| Jul 22, 2004 | Medex Inc Ventilator Circuit with ''Y'' & elbow with 2 Water Traps, for use with/compatible with Bennett 7200; product reorder 6072WT; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, Terminated |
BZO | None listed |
| Jul 22, 2004 | Medex Inc IPI Ventilator Circuit with 2 Water Traps, product reorder no. 6066; SIngle Patient Use Only; Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641 Terminated |
BZO | None listed |
| Jul 20, 2004 | Medex Inc Medex 3000 Series Syringe Infusion Pumps Terminated |
CAJ | None listed |
| Jul 29, 2003 | Medex Inc Medex 2000 Series Syringe Infusion Pumps. The 2001 series is a general use pump, 2001E is for German use, 2001G is for use in the UK, 2001T is for use in Taiwan, 2010iK is for use in Korea (the pumps Terminated |
CAJ | None listed |