Product code MEB— General Hospital
DIB INFUSOR
- Classification name
- Pump, Infusion, Elastomeric
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Total cleared
- 88
- First cleared
- Most recent
Market context for product code MEB
FDA has cleared devices under product code MEB between 1992 and 2026, filed by 42 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2024
- 2019
- 2016
- 2014
- 2013
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
Top applicants under product code MEB
Adverse events under product code MEB
product code MEB- Death
- 6
- Injury
- 160
- Malfunction
- 10,053
- Other
- 5
- Total
- 10,224
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MEB
- K250234 — SMARTeZ Elastomeric Infusion Pump (RS series)
- K240624 — InfuLife
- K242152 — SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
- K181360 — ON-Q* Pump with Bolus
- K151650 — SMARTez elastomeric infusion pump
- K131249 — ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
- K131247 — MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM
- K090300 — MODIFICATION TO AUTOFUSER
- K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP
- K071532 — ALPHA INFUSION PUMP, MODEL A200, A450
- K072921 — DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
- K072053 — SMARTBLOCK PAIN PUMP
- K071735 — MODIFICATION TO DISPOSABLE INFUSION PUMP KIT
- K071222 — INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
- K063530 — ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
- K061661 — STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20
- K062457 — INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
- K061409 — SMARTINFUSER PAINPUMP, MODEL P49220 W/CATHETER SET; P49224N W/O CATHETER SET
- K060258 — AUTOFUSER
- K060933 — SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM
- K052999 — SEMPERFLO INFUSION SYSTEM
- K051828 — NIPRO SUREFUSER AMBULATORY INFUSION PUMP
- K052451 — MPS ACACIA MEDFLO ELASTOMERIC PUMP
- K052117 — I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
- K051474 — SYMBIOS DISPOSABLE INFUSION PUMP KIT
- K050770 — MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT
- K042122 — SMARTINFUSER PAINPUMP
- K042246 — MULTI-DRIP INFUSION CATHETER
- K041585 — AUTOFUSER AMBULATORY INFUSION PUMP
- K040337 — I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
- K040752 — DOSI-FUSER
- K033039 — MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS
- K030830 — B. BRAUN NERVE BLOCK CATHETER
- K023883 — HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO
- K023098 — ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT
- K023318 — I-FLOW ELASTOMERIC PUMP WITH BOLUS
- K021964 — ALPHA INFUSION PUMP AND CATHETERS
- K021274 — PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
- K020988 — PAIN CARE 4200
- K020862 — I-FLOW ELASTOMERIC PUMP
- K020660 — HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO
- K013928 — PAIN CARE 3200
- K011117 — MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS
- K011317 — MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM
- K010824 — PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
- K003915 — ACCUFUSER; ACCUFUSER PLUS
- K003476 — MPS ACACIA PAIN KIT
- K002073 — PAIN CARE 3000
- K001342 — P.O.P. PAIN KIT
- K002321 — PAIN CARE 2000L
- K000263 — GO MEDICAL BALLOON INFUSION SYSTEM
- K993832 — AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10
- K993972 — DISPOSABLE INFUSION PUMP KIT
- K992551 — ALPHA INFUSION PUMP
- K991543 — INTRAOP CATHETER
- K992015 — FREEDOM INFUSION SYSTEM
- K990461 — MCKINLEY SP DISPOSABLE INFUSION PUMP
- K990889 — AUTODOSE INFUSION SYSTEM
- K984502 — NERVE BLOCK INFUSION KIT
- K983634 — PREPARE HOME INFUSION PUMP
- K983454 — PAIN CARE 2000
- K982946 — PAINBUSTER INFUSION KIT
- K982256 — OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP
- K982102 — SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY
- K980558 — PAINBUSTER INFUSION SYSTEM
- K972158 — GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
- K971362 — PERSONAL INFUSOR
- K972173 — MEDI-SIS SYRINGE INFUSION SYSTEM
- K971168 — ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE
- K965222 — MICROJECT MODEL PCA-1
- K962663 — SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET
- K963355 — SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET
- K955849 — DIB INFUSOR
- K960318 — DIB INFUSOR-RA
- K955727 — BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET
- K954059 — TITAN 20 CC DRIVER
- K953028 — TITAN DRIVER 60CC, 30 MINUTE ADMINISTRATION SET
- K941418 — INFUSION PUMP
- K944665 — DIB INFUSORS
- K943664 — INTERMATE XLV ELASTOMERIC INFUSION SYSTEM
- K940406 — DISPOSABLE, AMBULATORY, INFUSION PUMPS
- K941766 — DIB INFUSOR
- K940117 — MID-500
- K930404 — DIB INFUSOR
- K922382 — INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE
- K914148 — PRIME CADI-120
- K911636 — GENESIS(TM) INFUSION SYSTEM
- K913658 — IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD
Data sourced from openFDA. This site is unofficial and independent of the FDA.