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
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 452d recently vs 114d historically

FDA 510(k) Cleared Pump, Infusion, Elastomeric Devices (Product Code MEB)

88 devices
1–24 of 88
Cleared Apr 24, 2026
SMARTeZ™ Elastomeric Infusion Pump (RS series)
K250234
Epic Medical Pte. , Ltd.
General Hospital · 452d
Cleared Nov 05, 2024
InfuLife
K240624
First Medical Source, LLC
General Hospital · 245d
Cleared Oct 07, 2024
SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
K242152
Epic Medical Pte. , Ltd.
General Hospital · 76d
Cleared Mar 22, 2019
ON-Q* Pump with Bolus
K181360
Halyard Health
General Hospital · 304d
Cleared Apr 04, 2016
SMARTez elastomeric infusion pump
K151650
Epic Medical Pte. , Ltd.
General Hospital · 291d
Cleared Feb 03, 2014
ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
K131249
I-Flow, LLC
General Hospital · 278d
Cleared Aug 14, 2013
MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM
K131247
Mfs - Medical Flow Systems, Ltd.
General Hospital · 105d
Cleared Apr 30, 2009
MODIFICATION TO AUTOFUSER
K090300
Ace Medical Us, LLC
General Hospital · 83d
Cleared Jul 15, 2008
ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP
K081905
Westmed, Inc.
General Hospital · 12d
Cleared Feb 19, 2008
ALPHA INFUSION PUMP, MODEL A200, A450
K071532
Advanced Infusion, Inc.
General Hospital · 259d
Cleared Nov 26, 2007
DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
K072921
Symbios Medical Products, LLC
General Hospital · 42d
Cleared Nov 06, 2007
SMARTBLOCK PAIN PUMP
K072053
Medical Flow Systems, Ltd.
General Hospital · 103d
Cleared Jul 19, 2007
MODIFICATION TO DISPOSABLE INFUSION PUMP KIT
K071735
Symbios Medical Products, LLC
General Hospital · 23d
Cleared May 25, 2007
INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
K071222
Baxter Healthcare Corp
General Hospital · 23d
Cleared Jan 26, 2007
ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
K063530
I-Flow Corp.
General Hospital · 65d
Cleared Oct 18, 2006
STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20
K061661
Advanced Infusion, Inc.
General Hospital · 127d
Cleared Sep 21, 2006
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
K062457
Baxter Healthcare Corporation
General Hospital · 29d
Cleared Jun 16, 2006
SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET
K061409
Precise Medical Products, Ltd.
General Hospital · 25d
Cleared May 30, 2006
AUTOFUSER
K060258
Ace Medical Us, LLC
General Hospital · 118d
Cleared May 09, 2006
SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM
K060933
Apex Medical Technologies, Inc.
General Hospital · 34d
Cleared Mar 22, 2006
SEMPERFLO INFUSION SYSTEM
K052999
Ethicon, Inc.
General Hospital · 148d
Cleared Dec 15, 2005
NIPRO SUREFUSER AMBULATORY INFUSION PUMP
K051828
Nipro Medical Corporation
General Hospital · 162d
Cleared Dec 08, 2005
MPS ACACIA MEDFLO ELASTOMERIC PUMP
K052451
Mps Acacia
General Hospital · 92d
Cleared Sep 09, 2005
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
K052117
I-Flow Corp.
General Hospital · 36d

About Product Code MEB - Regulatory Context

510(k) Submission Activity

88 total 510(k) submissions under product code MEB since 1992, with 88 receiving FDA clearance (average review time: 118 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - MEB Product Code

Recent submissions under MEB have taken an average of 452 days to reach a decision - up from 114 days historically. Manufacturers should account for longer review timelines in current project planning.

MEB devices are reviewed by the General Hospital panel. Browse all General Hospital devices →