MEA · Class II · 21 CFR 880.5725

FDA Product Code MEA: Pump, Infusion, Pca

Leading manufacturers include Hospira, Inc., Baxter Healthcare Corp and Alaris Medical Systems, Inc..

31
Total
31
Cleared
162d
Avg days
1991
Since

FDA 510(k) Cleared Pump, Infusion, Pca Devices (Product Code MEA)

31 devices
1–24 of 31
Cleared Aug 29, 2017
ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
K162165
Summit Medical Products, Inc.
General Hospital · 391d
Cleared Aug 24, 2017
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication
K170982
Smiths Medical Ads, Inc.
General Hospital · 143d
Cleared Apr 08, 2016
LifeCare PCA Infusion System
K143612
Hospira, Inc.
General Hospital · 476d
Cleared Dec 09, 2013
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
K130394
Smiths Medical Asd, Inc.
General Hospital · 297d
Cleared Nov 04, 2009
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K092313
B.Braun Medical, Inc.
General Hospital · 97d
Cleared Mar 07, 2008
CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR
K072144
Smiths Medical MD, Inc.
General Hospital · 218d
Cleared Jul 15, 2005
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
K051253
Baxter Healthcare Corp
General Hospital · 60d
Cleared Dec 10, 2004
MEDLEY PCA MODULE, MODEL 8120
K043299
Alaris Medical Systems, Inc.
General Hospital · 10d
Cleared Dec 06, 2004
HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07
K043256
Hospira, Inc.
General Hospital · 12d
Cleared Oct 18, 2004
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K042800
Hospira, Inc.
General Hospital · 10d
Cleared Sep 09, 2003
MEDLEY PCA MODULE, MODEL 8120
K032233
Alaris Medical Systems, Inc.
General Hospital · 50d
Cleared Aug 19, 2003
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K031566
Baxter Healthcare Corp
General Hospital · 92d
Cleared May 30, 2003
STRYKER PAINPUMP2
K030661
Stryker Instruments
General Hospital · 88d
Cleared Aug 01, 2002
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K022203
Abbott Laboratories
General Hospital · 27d
Cleared Sep 11, 2000
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
K002739
Baxter Healthcare Corp
General Hospital · 10d
Cleared Apr 22, 1999
AVIA PAIN MEDICATION DELIVERY SYSTEM
K990312
Amtec Medical
General Hospital · 80d
Cleared Nov 02, 1998
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
K982839
Sims Deltec, Inc.
General Hospital · 82d
Cleared Feb 21, 1995
MODEL 6100 AMBULATORY INFUSION SYSTEM
K943310
Pharmacia Deltec, Inc.
General Hospital · 225d
Cleared Aug 03, 1992
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K921994
C.R. Bard, Inc.
General Hospital · 97d
Cleared Jun 03, 1992
IVAC PC ANIFUSER
K915063
Y
General Hospital · 208d
Cleared Dec 18, 1991
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K914502
C.R. Bard, Inc.
General Hospital · 70d
Cleared Jun 11, 1991
CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP
K911791
Pharmacia Deltec, Inc.
General Hospital · 50d

About Product Code MEA - Regulatory Context