Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medex, Inc. — Predicate Candidate Screening
48 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
175 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042432 | PHARMGUARD TOOLBOX, MODEL G6000782 | Medex, Inc. | 2005-01-04 | 118 | 0 |
| K040899 | MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP | Medex, Inc. | 2004-04-30 | 24 | 18 |
| K020780 | TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP | Medex, Inc. | 2002-05-20 | 70 | 2 |
| K000328 | MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP | Medex, Inc. | 2000-05-09 | 97 | 0 |
| K982640 | MEDEX 3000 SERIES SYRINGE INFUSION PUMP | Medex, Inc. | 1999-04-06 | 251 | 1 |
| K982123 | CONTRAST CONTROL DEVICE | Medex, Inc. | 1998-07-21 | 35 | 0 |
| K955231 | MEDFUSION MODEL 2001 SYRINGE INFUSION PUMP | Medex, Inc. | 1996-07-18 | 247 | 0 |
| K961404 | MX960 REUSABLE PRESSURE TRANSDUCER | Medex, Inc. | 1996-06-27 | 77 | 5 |
| K961527 | MX703 AND MX730 CONTINUOUS FLUSH DEVICES | Medex, Inc. | 1996-06-06 | 45 | 0 |
| K954970 | STOPCOCK & LUER LOCK PLUG | Medex, Inc. | 1996-04-22 | 175 | 1 |
| K952160 | INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA) | Medex, Inc. | 1995-09-21 | 136 | 0 |
| K951129 | NOVATRANS II | Medex, Inc. | 1995-04-05 | 23 | 0 |
| K943897 | NU-SITE | Medex, Inc. | 1995-02-10 | 184 | 7 |
| K944208 | IV ADMINISTRATION SET FPA | Medex, Inc. | 1994-12-13 | 106 | 0 |
| K942377 | TRANSTAR PRESSURE TRANSDUCER | Medex, Inc. | 1994-08-16 | 90 | 3 |
| K940896 | MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE | Medex, Inc. | 1994-08-11 | 168 | 0 |
| K922323 | MX4042/MC4044 SERIES SIMULCATH(TM) | Medex, Inc. | 1994-06-14 | 771 | 0 |
| K913498 | MX927 BLOOD TRANSFER DEVICE | Medex, Inc. | 1991-11-27 | 113 | 0 |
| K912709 | MX 339 TWIN HEMOSTATIC Y CONNECTOR | Medex, Inc. | 1991-09-11 | 84 | 0 |
| K910958 | MEDFLATOR INFLATION SYSTEM | Medex, Inc. | 1991-07-12 | 128 | 0 |
| K910227 | MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER | Medex, Inc. | 1991-04-03 | 75 | 0 |
| K904674 | CENTRAL VENOUS PRESSURE MANOMETER | Medex, Inc. | 1990-12-27 | 76 | 1 |
| K903199 | HOLLOW LUMEN NEEDLE, PART NUMBER: MX920 | Medex, Inc. | 1990-12-17 | 150 | 0 |
| K902771 | ARTERIAL BLOOD SAMPLING KIT | Medex, Inc. | 1990-11-05 | 137 | 3 |
| K883095 | MX860, REUSABLE PRESSURE TRANSDUCER | Medex, Inc. | 1988-09-12 | 52 | 0 |
| K883094 | MX350 (SERIES) CONTROL SYRINGE | Medex, Inc. | 1988-08-10 | 19 | 0 |
| K880696 | MX1002 CABLE-CAL TM | Medex, Inc. | 1988-06-15 | 114 | 0 |
| K880032 | MEDEX MACHINE | Medex, Inc. | 1988-02-11 | 37 | 1 |
| K874133 | MX710 SERIES VASCULAR ACCESS INFUSION SET | Medex, Inc. | 1988-01-14 | 93 | 0 |
| K872795 | CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE | Medex, Inc. | 1987-09-04 | 58 | 0 |
| K870301 | MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER | Medex, Inc. | 1987-05-06 | 98 | 0 |
| K860101 | MX4040 INTRAUTERINE PRESSURE MONITORING KIT | Medex, Inc. | 1986-04-14 | 94 | 0 |
| K853814 | MP0400 ADULT, PERISTALIC INFUSION PUMP | Medex, Inc. | 1986-01-16 | 126 | 0 |
| K844631 | PERIFLUX PF-2 | Medex, Inc. | 1985-02-20 | 85 | 0 |
| K830152 | MINILOOP I.V. CONNECTORS & ADAPTOR | Medex, Inc. | 1983-02-09 | 22 | 0 |
| K830178 | MINILOOP DISPOS. IV CONNECTORS ADAPT. | Medex, Inc. | 1983-02-07 | 20 | 0 |
| K822864 | INTRACRANIAL PRESSURE MONITORING DEVICE | Medex, Inc. | 1982-11-16 | 50 | 1 |
| K820355 | DISPOSABLE DIAPHRAGM DOMES | Medex, Inc. | 1982-03-04 | 24 | 1 |
| K810009 | DISPOSABLE DIAPHRAGM DOME | Medex, Inc. | 1981-02-19 | 45 | 0 |
| K800560 | MX820-5 PRESSURE INFUSOR 500CC MX820-10 | Medex, Inc. | 1980-04-29 | 48 | 0 |
| K792510 | MICROBAR MONITORING LINE FILTER | Medex, Inc. | 1979-12-20 | 15 | 0 |
| K790407 | MICROTEC BACTERIAL FILTER | Medex, Inc. | 1979-05-16 | 79 | 0 |
| K790408 | T-CONNECTOR | Medex, Inc. | 1979-04-30 | 63 | 0 |
| K790455 | MICROFLUSH | Medex, Inc. | 1979-03-23 | 18 | 0 |
| K790314 | FLUID ADMINISTRATION SETS, 15 MICRON | Medex, Inc. | 1979-03-06 | 21 | 1 |
| K782168 | 3-WAY STOPCOCK | Medex, Inc. | 1979-02-22 | 55 | 0 |
| K782167 | DELTA FLOW | Medex, Inc. | 1979-02-21 | 54 | 0 |
| K770432 | MICROFLUSH | Medex, Inc. | 1977-03-16 | 9 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda