FDA Product Code
FDA Product Code MEA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5725
510(k) Clearances — 31 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K162165 | ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump | Summit Medical Products, Inc. | 2017-08-29 | Traditional | PDF ↗ |
| K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) | Smiths Medical Ads, Inc. | 2017-08-24 | Traditional | PDF ↗ |
| K143612 | LifeCare PCA Infusion System | Hospira, Inc. | 2016-04-08 | Traditional | PDF ↗ |
| K130394 | CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 | Smiths Medical Asd, Inc. | 2013-12-09 | Traditional | PDF ↗ |
| K092313 | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM | B.Braun Medical, Inc. | 2009-11-04 | Traditional | PDF ↗ |
| K072144 | CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR | Smiths Medical MD, Inc. | 2008-03-07 | Traditional | PDF ↗ |
| K051253 | MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) | Baxter Healthcare Corp | 2005-07-15 | Traditional | PDF ↗ |
| K043299 | MEDLEY PCA MODULE, MODEL 8120 | Alaris Medical Systems, Inc. | 2004-12-10 | Traditional | PDF ↗ |
| K043256 | HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 | Hospira, Inc. | 2004-12-06 | Special | PDF ↗ |
| K042800 | LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | Hospira, Inc. | 2004-10-18 | Traditional | PDF ↗ |
| K033054 | HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP | Harvard Clinical Technology | 2003-12-16 | Traditional | PDF ↗ |
| K032233 | MEDLEY PCA MODULE, MODEL 8120 | Alaris Medical Systems, Inc. | 2003-09-09 | Traditional | PDF ↗ |
| K031566 | SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 | Baxter Healthcare Corp | 2003-08-19 | Traditional | PDF ↗ |
| K030661 | STRYKER PAINPUMP2 | Stryker Instruments | 2003-05-30 | Traditional | PDF ↗ |
| K020418 | GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES | P.T. Greenleaf | 2003-04-29 | Traditional | PDF ↗ |
| K020421 | GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES | Hennig Enterprises Europe Srl | 2003-04-29 | Traditional | PDF ↗ |
| K022203 | ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 | Abbott Laboratories | 2002-08-01 | Special | PDF ↗ |
| K013822 | MICROJET CRONO PCA | Cane S.R.L. | 2002-05-08 | Traditional | PDF ↗ |
| K002739 | INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K | Baxter Healthcare Corp | 2000-09-11 | Special | PDF ↗ |
| K002434 | PALM PUMP | Sorenson Medical, Inc. | 2000-08-23 | Special | PDF ↗ |
| K990312 | AVIA PAIN MEDICATION DELIVERY SYSTEM | Amtec Medical | 1999-04-22 | Traditional | PDF ↗ |
| K982839 | CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 | Sims Deltec, Inc. | 1998-11-02 | Traditional | PDF ↗ |
| K943310 | MODEL 6100 AMBULATORY INFUSION SYSTEM | Pharmacia Deltec, Inc. | 1995-02-21 | Traditional | PDF ↗ |
| K934551 | VERIFUSE AMBULATORY PUMP | Block Medical, Inc. | 1994-03-17 | Traditional | PDF ↗ |
| K920637 | PRIME PCA AND PCA/CONTINUOUS SYSTEMS | Prime Medical Products, Inc. | 1993-01-15 | Traditional | PDF ↗ |
| K915270 | PATIENT CONTROLLED SYRINGE PUMP TYPE 3300 | Graseby Medical , Ltd. | 1992-08-24 | Traditional | PDF ↗ |
| K921994 | BARD PCA II PUMP WITH PROGRAM CARTRIDGES | C.R. Bard, Inc. | 1992-08-03 | Traditional | PDF ↗ |
| K915063 | IVAC PC ANIFUSER | Y | 1992-06-03 | Traditional | PDF ↗ |
| K914502 | BARD PCA II PUMP WITH PROGRAM CARTRIDGES | C.R. Bard, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K910257 | BAXA PCA INFUSOR | Baxa Corp., Sub. of Cook Group, Inc. | 1991-11-07 | Traditional | PDF ↗ |
| K911791 | CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP | Pharmacia Deltec, Inc. | 1991-06-11 | Traditional | PDF ↗ |
Product code MEA · Class II · General Hospital. Data: openFDA.