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
49–72 of 88
Cleared Sep 07, 2000
P.O.P. PAIN KIT
K001342
Post Operative Pain Management
General Hospital · 133d
Cleared Aug 14, 2000
PAIN CARE 2000L
K002321
Breg, Inc.
General Hospital · 14d
Cleared May 09, 2000
GO MEDICAL BALLOON INFUSION SYSTEM
K000263
Go Medical Industries Pty. , Ltd.
General Hospital · 102d
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
Cleared Jun 19, 1997
MICROJECT MODEL PCA-1
K965222
Microject, Inc.
General Hospital · 170d
Cleared Oct 04, 1996
SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET
K962663
Solopak Medical Products, Inc.
General Hospital · 88d
Cleared Oct 04, 1996
SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET
K963355
Solopak Medical Products, Inc.
General Hospital · 39d