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
Growing category - 3 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 258d recently vs 113d 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 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 Sep 21, 2006
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
K062457
Baxter Healthcare Corporation
General Hospital · 29d
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 Sep 09, 2005
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
K052117
I-Flow Corp.
General Hospital · 36d
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 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 Oct 18, 2002
I-FLOW ELASTOMERIC PUMP WITH BOLUS
K023318
I-Flow Corp.
General Hospital · 14d
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

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 increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MEB Product Code

Recent submissions under MEB have taken an average of 258 days to reach a decision - up from 113 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 →