MEB · Class II · 21 CFR 880.5725

FDA Product Code MEB: Pump, Infusion, Elastomeric

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

88
Total
88
Cleared
118d
Avg days
1992
Since
88 devices
25–48 of 88
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 Jun 28, 2001
MULTIRATE INFUSOR SV
K011317
Baxter Healthcare Corp
General Hospital · 59d
Cleared Sep 19, 2000
PAIN CARE 3000
K002073
Breg, Inc.
General Hospital · 71d
Cleared Aug 14, 2000
PAIN CARE 2000L
K002321
Breg, Inc.
General Hospital · 14d
Cleared Feb 09, 2000
AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10
K993832
Tandem Medical, Inc.
General Hospital · 89d
Cleared Feb 07, 2000
DISPOSABLE INFUSION PUMP KIT
K993972
Biomet, Inc.
General Hospital · 76d
Cleared Oct 27, 1999
ALPHA INFUSION PUMP
K992551
Advanced Infusion, Inc.
General Hospital · 89d
Cleared Oct 25, 1999
INTRAOP CATHETER
K991543
I-Flow Corp.
General Hospital · 175d
Cleared Sep 10, 1999
FREEDOM INFUSION SYSTEM
K992015
Novacon Corp.
General Hospital · 87d
Cleared Jun 30, 1999
MCKINLEY SP DISPOSABLE INFUSION PUMP
K990461
Mckinley, Inc.
General Hospital · 138d
Cleared Jun 03, 1999
AUTODOSE INFUSION SYSTEM
K990889
Tandem Medical, Inc.
General Hospital · 78d
Cleared Mar 04, 1999
NERVE BLOCK INFUSION KIT
K984502
I-Flow Corp.
General Hospital · 76d
Cleared Feb 24, 1999
PREPARE HOME INFUSION PUMP
K983634
Medical Infusion Technologies, Inc.
General Hospital · 132d
Cleared Dec 16, 1998
PAIN CARE 2000
K983454
Breg, Inc.
General Hospital · 77d
Cleared Nov 18, 1998
PAINBUSTER INFUSION KIT
K982946
I-Flow Corp.
General Hospital · 89d
Cleared Sep 30, 1998
OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP
K982256
Mckinley, Inc.
General Hospital · 96d
Cleared Sep 04, 1998
SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY
K982102
Baxter Healthcare Corp
General Hospital · 81d
Cleared May 28, 1998
PAINBUSTER INFUSION SYSTEM
K980558
I-Flow Corp.
General Hospital · 104d
Cleared Feb 20, 1998
GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
K972158
Princeton Regulatory Assoc.
General Hospital · 256d
Cleared Dec 04, 1997
PERSONAL INFUSOR
K971362
Science Incorporated
General Hospital · 237d
Cleared Aug 15, 1997
MEDI-SIS SYRINGE INFUSION SYSTEM
K972173
I-Flow Corp.
General Hospital · 67d
Cleared Jul 15, 1997
ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE
K971168
Baxter Healthcare Corp
General Hospital · 106d