Product Code: MEB FDA class 2 21 CFR 880.5725

Pump, Infusion, Elastomeric

General Hospital

The elastomeric infusion pump is a general hospital device that uses the elastic properties of a balloon reservoir to deliver intravenous medications or fluids at a controlled rate without requiring electronic power, commonly used for outpatient infusion therapy. It is classified as FDA Class II under 21 CFR 880.5725 within the General Hospital specialty, requiring 510(k) premarket clearance. The product code is MEB and the device is not implanted. Full GMP quality system requirements apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: MEB
Device Class: FDA class 2
Regulation Number: 880.5725
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 88 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250234	SMARTeZ Elastomeric Infusion Pump (RS series)	Apr 24, 2026	Substantially Equivalent	Epic Medical Pte. , Ltd.
K240624	InfuLife	Nov 05, 2024	Substantially Equivalent	First Medical Source, LLC
K242152	SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)	Oct 07, 2024	Substantially Equivalent	Epic Medical Pte. , Ltd.
K181360	ON-Q* Pump with Bolus	Mar 22, 2019	Substantially Equivalent	Halyard Health
K151650	SMARTez elastomeric infusion pump	Apr 04, 2016	Substantially Equivalent	Epic Medical Pte. , Ltd.
K131249	ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES	Feb 03, 2014	Substantially Equivalent	I-Flow, LLC
K131247	MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM	Aug 14, 2013	Substantially Equivalent	Mfs - Medical Flow Systems, Ltd.
K090300	MODIFICATION TO AUTOFUSER	Apr 30, 2009	Substantially Equivalent	Ace Medical Us, LLC
K081905	ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP	Jul 15, 2008	Substantially Equivalent	Westmed, Inc.
K071532	ALPHA INFUSION PUMP, MODEL A200, A450	Feb 19, 2008	Substantially Equivalent	Advanced Infusion, Inc.
K072921	DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM	Nov 26, 2007	Substantially Equivalent	Symbios Medical Products, LLC
K072053	SMARTBLOCK PAIN PUMP	Nov 06, 2007	Substantially Equivalent	Medical Flow Systems, Ltd.
K071735	MODIFICATION TO DISPOSABLE INFUSION PUMP KIT	Jul 19, 2007	Substantially Equivalent	Symbios Medical Products, LLC
K071222	INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES	May 25, 2007	Substantially Equivalent	Baxter Healthcare Corp
K063530	ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP	Jan 26, 2007	Substantially Equivalent	I-Flow Corp.
K061661	STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20	Oct 18, 2006	Substantially Equivalent	Advanced Infusion, Inc.
K062457	INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES	Sep 21, 2006	Substantially Equivalent	Baxter Healthcare Corporation
K061409	SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET	Jun 16, 2006	Substantially Equivalent	Precise Medical Products, Ltd.
K060258	AUTOFUSER	May 30, 2006	Substantially Equivalent	Ace Medical Us, LLC
K060933	SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM	May 09, 2006	Substantially Equivalent	Apex Medical Technologies, Inc.
K052999	SEMPERFLO INFUSION SYSTEM	Mar 22, 2006	Substantially Equivalent	ETHICON, Inc.
K051828	NIPRO SUREFUSER AMBULATORY INFUSION PUMP	Dec 15, 2005	Substantially Equivalent	Nipro Medical Corporation
K052451	MPS ACACIA MEDFLO ELASTOMERIC PUMP	Dec 08, 2005	Substantially Equivalent	Mps Acacia
K052117	I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)	Sep 09, 2005	Substantially Equivalent	I-Flow Corp.
K051474	SYMBIOS DISPOSABLE INFUSION PUMP KIT	Jul 01, 2005	Substantially Equivalent	Symbios Medical Products, LLC
K050770	MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT	Apr 14, 2005	Substantially Equivalent	Mckinley Medical, LLC
K042122	SMARTINFUSER PAINPUMP	Sep 22, 2004	Substantially Equivalent	Precise Medical Products
K042246	MULTI-DRIP INFUSION CATHETER	Aug 31, 2004	Substantially Equivalent	Advanced Infusion, Inc.
K041585	AUTOFUSER AMBULATORY INFUSION PUMP	Aug 26, 2004	Substantially Equivalent	Algos, LC
K040337	I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)	May 24, 2004	Substantially Equivalent	I-Flow Corp.
K040752	DOSI-FUSER	Apr 07, 2004	Substantially Equivalent	Leventon, S.A.
K033039	MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS	Oct 07, 2003	Substantially Equivalent	Mckinley, Inc.
K030830	B. BRAUN NERVE BLOCK CATHETER	Jul 15, 2003	Substantially Equivalent	B.Braun Medical, Inc.
K023883	HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO	Dec 20, 2002	Substantially Equivalent	I-Flow Corp.
K023098	ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT	Dec 09, 2002	Substantially Equivalent	Mckinley Infuser
K023318	I-FLOW ELASTOMERIC PUMP WITH BOLUS	Oct 18, 2002	Substantially Equivalent	I-Flow Corp.
K021964	ALPHA INFUSION PUMP AND CATHETERS	Aug 12, 2002	Substantially Equivalent	Advanced Infusion, Inc.
K021274	PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719	May 17, 2002	Substantially Equivalent	Baxter Healthcare Corp
K020988	PAIN CARE 4200	Apr 04, 2002	Substantially Equivalent	Breg, Inc.
K020862	I-FLOW ELASTOMERIC PUMP	Mar 26, 2002	Substantially Equivalent	I-Flow Corp.
K020660	HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO	Mar 20, 2002	Substantially Equivalent	I-Flow Corp.
K013928	PAIN CARE 3200	Dec 03, 2001	Substantially Equivalent	Breg, Inc.
K011117	MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS	Jul 09, 2001	Substantially Equivalent	Mps Acacia
K011317	MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM	Jun 28, 2001	Substantially Equivalent	Baxter Healthcare Corp
K010824	PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT	Jun 05, 2001	Substantially Equivalent	Science Incorporated
K003915	ACCUFUSER; ACCUFUSER PLUS	Feb 15, 2001	Substantially Equivalent	Help Technologies
K003476	MPS ACACIA PAIN KIT	Jan 12, 2001	Substantially Equivalent	Mps Acacia
K002073	PAIN CARE 3000	Sep 19, 2000	Substantially Equivalent	Breg, Inc.
K001342	P.O.P. PAIN KIT	Sep 07, 2000	Substantially Equivalent	Post Operative Pain Management
K002321	PAIN CARE 2000L	Aug 14, 2000	Substantially Equivalent	Breg, Inc.
K000263	GO MEDICAL BALLOON INFUSION SYSTEM	May 09, 2000	Substantially Equivalent	Go Medical Industries Pty. , Ltd.
K993832	AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10	Feb 09, 2000	Substantially Equivalent	Tandem Medical, Inc.
K993972	DISPOSABLE INFUSION PUMP KIT	Feb 07, 2000	Substantially Equivalent	Biomet, Inc.
K992551	ALPHA INFUSION PUMP	Oct 27, 1999	Substantially Equivalent	Advanced Infusion, Inc.
K991543	INTRAOP CATHETER	Oct 25, 1999	Substantially Equivalent	I-Flow Corp.
K992015	FREEDOM INFUSION SYSTEM	Sep 10, 1999	Substantially Equivalent	Novacon Corp.
K990461	MCKINLEY SP DISPOSABLE INFUSION PUMP	Jun 30, 1999	Substantially Equivalent	Mckinley, Inc.
K990889	AUTODOSE INFUSION SYSTEM	Jun 03, 1999	Substantially Equivalent	Tandem Medical, Inc.
K984502	NERVE BLOCK INFUSION KIT	Mar 04, 1999	Substantially Equivalent	I-Flow Corp.
K983634	PREPARE HOME INFUSION PUMP	Feb 24, 1999	Substantially Equivalent	Medical Infusion Technologies, Inc.
K983454	PAIN CARE 2000	Dec 16, 1998	Substantially Equivalent	Breg, Inc.
K982946	PAINBUSTER INFUSION KIT	Nov 18, 1998	Substantially Equivalent	I-Flow Corp.
K982256	OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP	Sep 30, 1998	Substantially Equivalent	Mckinley, Inc.
K982102	SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY	Sep 04, 1998	Substantially Equivalent	Baxter Healthcare Corp
K980558	PAINBUSTER INFUSION SYSTEM	May 28, 1998	Substantially Equivalent	I-Flow Corp.
K972158	GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES	Feb 20, 1998	Substantially Equivalent	Princeton Regulatory Assoc.
K971362	PERSONAL INFUSOR	Dec 04, 1997	Substantially Equivalent	Science Incorporated
K972173	MEDI-SIS SYRINGE INFUSION SYSTEM	Aug 15, 1997	Substantially Equivalent	I-Flow Corp.
K971168	ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE	Jul 15, 1997	Substantially Equivalent	Baxter Healthcare Corp
K965222	MICROJECT MODEL PCA-1	Jun 19, 1997	Substantially Equivalent	Microject, Inc.
K963355	SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET	Oct 04, 1996	Substantially Equivalent	Solopak Medical Products, Inc.
K962663	SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET	Oct 04, 1996	Substantially Equivalent	Solopak Medical Products, Inc.
K960318	DIB INFUSOR-RA	Aug 05, 1996	Substantially Equivalent	Novacon Corp.
K955849	DIB INFUSOR	Aug 05, 1996	Substantially Equivalent	Novacon Corp.
K955727	BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET	Feb 08, 1996	Substantially Equivalent	I-Flow Corp.
K954059	TITAN 20 CC DRIVER	Sep 29, 1995	Substantially Equivalent	I-Flow Corp.
K953028	TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET	Sep 28, 1995	Substantially Equivalent	I-Flow Corp.
K941418	INFUSION PUMP	Jul 18, 1995	Substantially Equivalent	I-Flow Corp.
K944665	DIB INFUSORS	Feb 14, 1995	Substantially Equivalent - Subject to Tracking Reg.	Novacon Corp.
K943664	INTERMATE XLV ELASTOMERIC INFUSION SYSTEM	Nov 03, 1994	Substantially Equivalent	Baxter Healthcare Corp
K940406	DISPOSABLE, AMBULATORY, INFUSION PUMPS	Sep 02, 1994	Substantially Equivalent - Subject to Tracking Reg.	Vlv Associates, Inc.
K941766	DIB INFUSOR	Aug 05, 1994	Substantially Equivalent - Subject to Tracking Reg.	Novacon Corp.
K940117	MID-500	Jun 10, 1994	Substantially Equivalent - Subject to Tracking Reg.	Block Medical, Inc.
K930404	DIB INFUSOR	Feb 25, 1994	Substantially Equivalent	Novacon Corp.
K922382	INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE	Feb 05, 1993	Substantially Equivalent	Baxter Healthcare Corp
K914148	PRIME CADI-120	Oct 05, 1992	Substantially Equivalent	Prime Medical Products, Inc.
K911636	GENESIS(TM) INFUSION SYSTEM	Jul 17, 1992	Substantially Equivalent	Norman'S
K913658	IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD	Mar 26, 1992	Substantially Equivalent	Imed Corp.