FDA Product Code
FDA Product Code FRN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5725
510(k) Clearances — 849 records · page 2 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K061325 | BODYGAURD PAIN MANAGER INFUSION SYSTEM | Caesarea Medical Electronics , Ltd. | 2006-08-24 | Abbreviated | PDF ↗ |
| K053554 | COMPUFLO | Milestone Scientific, Inc. | 2006-07-10 | Traditional | PDF ↗ |
| K061128 | MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM | Medrad, Inc. | 2006-05-22 | Special | PDF ↗ |
| K060479 | MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM | Caesarea Medical Electronics , Ltd. | 2006-05-12 | Traditional | PDF ↗ |
| K060806 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 | Hospira, Inc. | 2006-04-21 | Special | PDF ↗ |
| K052817 | EUREKA INFUSION PUMP, MODELS EUREKA-IP, EUREKA-LF | Universal Medical Technologies | 2006-04-17 | Traditional | PDF ↗ |
| K060119 | MCKINLEY SATURATION CATHETER | Mckinley Medical, LLC | 2006-04-12 | Traditional | PDF ↗ |
| K052594 | WILLCARE, MODEL GW-1020 | Icu Medical, Inc. | 2006-02-10 | Traditional | PDF ↗ |
| K053226 | ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER | Zimmer, Inc. | 2006-01-31 | Traditional | PDF ↗ |
| K052221 | AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP | Sorenson Medical, Inc. | 2005-12-08 | Abbreviated | PDF ↗ |
| K052218 | CRONO FIVE AND CRONO PCA 50 | Cane S.R.L. | 2005-11-23 | Traditional | PDF ↗ |
| K050800 | NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS | Caesarea Medical Electronics , Ltd. | 2005-11-23 | Traditional | PDF ↗ |
| K051568 | CADD-MS 3 AMBULATORY INFUSION PUMP | Smiths Medical MD, Inc. | 2005-11-17 | Traditional | PDF ↗ |
| K051641 | ALARIS SYSTEM PC UNIT, MODEL 8001 | Cardinal Health, Alaris Products | 2005-10-20 | Traditional | PDF ↗ |
| K052171 | ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE | Zimmer, Inc. | 2005-10-13 | Traditional | PDF ↗ |
| K052219 | CRONO GO. | Cane S.R.L. | 2005-09-13 | Special | PDF ↗ |
| K052217 | CRONO SUPER PID | Cane S.R.L. | 2005-09-13 | Special | PDF ↗ |
| K052052 | HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 | Hospira, Inc. | 2005-08-24 | Special | PDF ↗ |
| K051045 | SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30 | Spectrx, Inc. | 2005-08-02 | Special | PDF ↗ |
| K051252 | MICROPUMP MP-101 | Micrel Medical Devices S.A. | 2005-05-27 | Traditional | PDF ↗ |
| K043466 | PAINPUMP2 | Stryker Instruments | 2005-05-10 | Traditional | PDF ↗ |
| K050324 | INFPUMP INFILTRATION PUMP | Carolina Medical, Inc. | 2005-04-27 | Traditional | PDF ↗ |
| K050474 | VEINNOVATIONS INFILTRATION SYSTEM | Veinnovations, LLC | 2005-04-14 | Traditional | PDF ↗ |
| K050433 | ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM | Zimmer Orthopaedic Surgical Products | 2005-04-13 | Traditional | PDF ↗ |
| K043204 | SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP | Sgarlato Laboratories, Inc. | 2005-03-30 | Traditional | PDF ↗ |
| K043600 | MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C | Medtronic Minimed | 2005-03-29 | Traditional | PDF ↗ |
| K043590 | SE INFUSION SYSTEM WITH MMS | Cardinal Health, Alaris Products | 2005-03-25 | Traditional | PDF ↗ |
| K050301 | MRIDIUM 3850 MRI PUMP SYSTEM | Iradimed Corporation | 2005-03-24 | Traditional | PDF ↗ |
| K042696 | BODYGUARD INFUSION PUMP SYSTEM | Caesarea Medical Electronics , Ltd. | 2005-03-11 | Traditional | PDF ↗ |
| K050107 | HARVARD 2 SYRINGE PUMP, MODEL 2001-001 | Harvard Clinical Technology | 2005-02-11 | Special | PDF ↗ |
| K042432 | PHARMGUARD TOOLBOX, MODEL G6000782 | Medex, Inc. | 2005-01-04 | Traditional | PDF ↗ |
| K040985 | PUMP CONNECTIVITY INTERFACE | Baxter Healthcare Corp | 2004-11-30 | Traditional | PDF ↗ |
| K042980 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE | Hospira, Inc. | 2004-11-17 | Special | PDF ↗ |
| K042228 | BEELINE MOTIV, PROPOLIS, PCA | Mckinley, Inc. | 2004-11-08 | Traditional | PDF ↗ |
| K042405 | PAINPUMP1; PAINPUMP2 | Stryker Corp. | 2004-10-14 | Traditional | PDF ↗ |
| K042609 | HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE | Hospira, Inc. | 2004-10-06 | Traditional | PDF ↗ |
| K041714 | E-PAIN CARE | Breg, Inc. | 2004-10-01 | Traditional | PDF ↗ |
| K042085 | CRONO F | Cane S.R.L. | 2004-09-17 | Special | PDF ↗ |
| K042121 | SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY | Sigma Intl. | 2004-08-26 | Traditional | PDF ↗ |
| K042081 | PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | Hospira, Inc. | 2004-08-24 | Traditional | PDF ↗ |
| K041738 | BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME) | Baxter Healthcare Corporation | 2004-07-09 | Special | PDF ↗ |
| K041414 | CRONO AND CRONO, MODEL 30 | Cane S.R.L. | 2004-07-08 | Special | PDF ↗ |
| K041241 | MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 | Alaris Medical Systems, Inc. | 2004-07-06 | Traditional | PDF ↗ |
| K041550 | HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | Abbott Laboratories | 2004-06-30 | Traditional | PDF ↗ |
| K041191 | COLLEAGUE VOLUMETRIC INFUSION PUMPS | Baxter Healthcare Corp | 2004-06-25 | Traditional | PDF ↗ |
| K040149 | PSI-TEC PERISTALTIC INFILTRATION PUMP | Byron Medical | 2004-06-03 | Traditional | PDF ↗ |
| K041152 | THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A | Applied Diabetes Research, Inc. | 2004-05-24 | Special | PDF ↗ |
| K040899 | MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP | Medex, Inc. | 2004-04-30 | Traditional | PDF ↗ |
| K040061 | MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C | Medtronic Minimed | 2004-04-08 | Traditional | PDF ↗ |
| K040114 | ABBOTT DATA PORT PC, MODEL 12181 | Abbott Laboratories | 2004-01-29 | Special | PDF ↗ |
| K030739 | INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE | Infusion Dynamics, Inc. | 2004-01-14 | Traditional | PDF ↗ |
| K033325 | AMBIT CONTINUOUS AMBULATORY INFUSION PUMP | Sorenson Medical, Inc. | 2003-11-06 | Special | PDF ↗ |
| K033425 | AMBIT INTERMITTENT AMBULATORY INFUSION PUMP | Sorenson Medical, Inc. | 2003-11-06 | Special | PDF ↗ |
| K032789 | REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 | American I.V. Products, Inc. | 2003-10-09 | Traditional | PDF ↗ |
| K032642 | BEELINE SYSTEM | Mckinley, Inc. | 2003-09-23 | Special | PDF ↗ |
| K032771 | MEDRAD CONTINUUM MR INFUSION SYSTEM | Medrad, Inc. | 2003-09-23 | Special | PDF ↗ |
| K032005 | MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332 | Medtronic Minimed | 2003-08-22 | Traditional | PDF ↗ |
| K031749 | BODYGUARD INFUSION SYSTEM | Caesarea Medical Electronics , Ltd. | 2003-08-21 | Traditional | PDF ↗ |
| K031600 | CONDUCTION CATHETER | Micor, Inc. | 2003-08-13 | Traditional | PDF ↗ |
| K031432 | KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II | Hk Surgical, Inc. | 2003-08-07 | Abbreviated | PDF ↗ |
| K032147 | SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES | Alaris Medical Systems, Inc. | 2003-07-25 | Special | PDF ↗ |
| K031249 | MODIFICATION TO STRYKER PAINPUMP | Stryker Instruments | 2003-07-21 | Traditional | PDF ↗ |
| K030576 | ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II | The Anspach Effort, Inc. | 2003-05-21 | Traditional | PDF ↗ |
| K031185 | ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE | Abbott Laboratories | 2003-04-30 | Traditional | PDF ↗ |
| K030885 | MODIFICATION TO STRYKER PAINPUMP2 | Stryker Instruments | 2003-04-18 | Special | PDF ↗ |
| K030459 | MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) | Alaris Medical Systems, Inc. | 2003-04-04 | Traditional | PDF ↗ |
| K030323 | MRI-CADDY | Mammendorfer Institute For Physics & Medicine GmbH | 2003-04-02 | Traditional | PDF ↗ |
| K023189 | VISTA BASIC WITH FM SYSTEM | B.Braun Medical, Inc. | 2003-03-20 | Traditional | PDF ↗ |
| K024190 | FENESTRATED INFUSION CATHETER | Promedic, Inc. | 2003-03-17 | Traditional | PDF ↗ |
| K023083 | SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800 | Mettler Electronics Corp. | 2003-02-28 | Abbreviated | PDF ↗ |
| K023973 | AUTOMED 3200 INFUSION PUMP | Help Technologies | 2003-02-27 | Traditional | PDF ↗ |
| K023863 | AUTOMED 3000 INFUSION PUMP | Help Technologies | 2003-02-07 | Traditional | PDF ↗ |
| K024056 | SURESET 3.0 ML RESERVOIR, MODEL 24-103 | Applied Diabetes Research, Incorporated | 2003-01-17 | Traditional | PDF ↗ |
| K024084 | ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391 | Abbott Laboratories | 2002-12-31 | Special | PDF ↗ |
| K023264 | MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 | Alaris Medical Systems, Inc. | 2002-12-19 | Traditional | PDF ↗ |
| K023827 | PARAGON INFUSION SYSTEM WITH BOLUS | I-Flow Corp. | 2002-12-13 | Special | PDF ↗ |
| K023491 | AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM | Help Technologies | 2002-12-13 | Traditional | PDF ↗ |
| K023062 | GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT | Abbott Laboratories, Inc. | 2002-09-30 | Special | PDF ↗ |
| K022869 | SOAKER CATHETER | I-Flow Corp. | 2002-09-20 | Special | PDF ↗ |
| K021988 | MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM | Medrad, Inc. | 2002-08-29 | Abbreviated | PDF ↗ |
| K022575 | PERFUSOR COMPACT WITH FM SYSTEM | B.Braun Medical, Inc. | 2002-08-21 | Traditional | PDF ↗ |
| K013840 | MICROJET CRONO PAR AND CRONO APO-GO | Cane S.R.L. | 2002-05-14 | Traditional | PDF ↗ |
| K021350 | ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348 | Abbott Laboratories | 2002-05-14 | Special | PDF ↗ |
| K013855 | MICROJET CRONO H | Cane S.R.I. | 2002-05-09 | Traditional | PDF ↗ |
| K013776 | MICROJET MODEL # CD4 AND CD4/20 | Cane S.R.I. | 2002-04-26 | Traditional | PDF ↗ |
| K013234 | MICROJET CRONO | Cane S.R.L. | 2002-04-26 | Traditional | PDF ↗ |
| K020947 | MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS | Smith & Nephew, Inc. | 2002-04-17 | Special | PDF ↗ |
| K020881 | MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT | Science Incorporated | 2002-03-27 | Special | PDF ↗ |
| K020251 | PARAGON INFUSION SYSTEM | I-Flow Corp. | 2002-02-15 | Special | PDF ↗ |
| K014091 | STRYKER PAINPUMP | Stryker Corp. | 2001-12-31 | Special | PDF ↗ |
| K013767 | SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP | Sterling Medivations, Inc. | 2001-12-12 | Traditional | PDF ↗ |
| K012383 | GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C | Alaris Medical Systems, Inc. | 2001-10-02 | Traditional | PDF ↗ |
| K011975 | HORIZON OUTLOOK WITH DOSECOM | B.Braun Medical, Inc. | 2001-09-19 | Traditional | PDF ↗ |
| K012044 | BI-PHASIC INFILTRATOR | Reliance Medical Corp. | 2001-08-28 | Traditional | PDF ↗ |
| K003966 | WUNDCATH CONDUCTION CATHETER | Micor, Inc. | 2001-07-17 | Traditional | PDF ↗ |
| K010937 | SEP-10S PLUS, AND SP-12S PRO. | Viltechmeda | 2001-06-25 | Traditional | PDF ↗ |
| K003543 | STRYKER PAINPUMP PCA | Stryker Instruments | 2001-06-05 | Traditional | PDF ↗ |
| K011442 | ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 | Abbott Laboratories | 2001-06-05 | Special | PDF ↗ |
| K010566 | COLLEAGUE VOLUMETRIC INFUSION PUMP | Baxter Healthcare Corp | 2001-05-15 | Traditional | PDF ↗ |
| K011096 | ABBOTT ACCLAIM ENCORE, MODEL 12237 | Abbott Laboratories | 2001-05-01 | Special | PDF ↗ |
Product code FRN · Class II · General Hospital. Data: openFDA.