MEB · Class II · 21 CFR 880.5725

FDA Product Code MEB: Pump, Infusion, Elastomeric

Leading manufacturers include I-Flow Corp., Baxter Healthcare Corp and Novacon Corp..

88
Total
88
Cleared
118d
Avg days
1992
Since
88 devices
25–48 of 88
Cleared Jul 01, 2005
SYMBIOS DISPOSABLE INFUSION PUMP KIT
K051474
Symbios Medical Products, LLC
General Hospital · 28d
Cleared Apr 14, 2005
MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT
K050770
Mckinley Medical, LLC
General Hospital · 20d
Cleared Sep 22, 2004
SMARTINFUSER PAINPUMP
K042122
Precise Medical Products
General Hospital · 47d
Cleared Aug 31, 2004
MULTI-DRIP INFUSION CATHETER
K042246
Advanced Infusion, Inc.
General Hospital · 12d
Cleared Aug 26, 2004
AUTOFUSER AMBULATORY INFUSION PUMP
K041585
Algos, LC
General Hospital · 73d
Cleared May 24, 2004
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
K040337
I-Flow Corp.
General Hospital · 103d
Cleared Apr 07, 2004
DOSI-FUSER
K040752
Leventon, S.A.
General Hospital · 14d
Cleared Oct 07, 2003
MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS
K033039
Mckinley, Inc.
General Hospital · 8d
Cleared Jul 15, 2003
B. BRAUN NERVE BLOCK CATHETER
K030830
B.Braun Medical, Inc.
General Hospital · 123d
Cleared Dec 20, 2002
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO
K023883
I-Flow Corp.
General Hospital · 29d
Cleared Dec 09, 2002
ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT
K023098
Mckinley Infuser
General Hospital · 82d
Cleared Oct 18, 2002
I-FLOW ELASTOMERIC PUMP WITH BOLUS
K023318
I-Flow Corp.
General Hospital · 14d
Cleared Aug 12, 2002
ALPHA INFUSION PUMP AND CATHETERS
K021964
Advanced Infusion, Inc.
General Hospital · 59d
Cleared May 17, 2002
PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
K021274
Baxter Healthcare Corp
General Hospital · 25d
Cleared Apr 04, 2002
PAIN CARE 4200
K020988
Breg, Inc.
General Hospital · 8d
Cleared Mar 26, 2002
I-FLOW ELASTOMERIC PUMP
K020862
I-Flow Corp.
General Hospital · 8d
Cleared Mar 20, 2002
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
K020660
I-Flow Corp.
General Hospital · 19d
Cleared Dec 03, 2001
PAIN CARE 3200
K013928
Breg, Inc.
General Hospital · 5d
Cleared Jul 09, 2001
MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS
K011117
Mps Acacia
General Hospital · 88d
Cleared Jun 28, 2001
MULTIRATE INFUSOR SV
K011317
Baxter Healthcare Corp
General Hospital · 59d
Cleared Jun 05, 2001
PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
K010824
Science Incorporated
General Hospital · 78d
Cleared Feb 15, 2001
ACCUFUSER
K003915
Help Technologies
General Hospital · 58d
Cleared Jan 12, 2001
MPS ACACIA PAIN KIT
K003476
Mps Acacia
General Hospital · 64d
Cleared Sep 19, 2000
PAIN CARE 3000
K002073
Breg, Inc.
General Hospital · 71d