510(k) K011117
- Device
- MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS
- Applicant
- MPS ACACIA
- 510(k) number
- K011117
- Product code
- MEB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-07-09
- Date received
- 2001-04-12
- Regulation
- 880.5725
- Classification name
- Pump, Infusion, Elastomeric
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- FERGIE F FERGUSON
- Address
- 499 Nibus St., Suite E Brea CA US 92821 92821
FDA Registration Numbers#
- 3010055973
- 1416980
- 9610825
- 3012429465
- 3022518300
- 3005126704
- 3013764800
- 3011137372
- 2029275
- 3010041511
- 3003898360
- 2025695
- 3002907620
- 3009171251
- 3011270181
- 3004365956
- 2030624
- 3024702421
- 3007008418
- 9680787
- 3010220595
- 9680425
- 1319639
- 9612086
Source Documents#
Other 510(k) Records For Product Code MEB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. | 2026-04-24 |
| K240624 | InfuLife | First Medical Source, LLC | 2024-11-05 |
| K242152 | SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | Epic Medical Pte. , Ltd. | 2024-10-07 |
| K181360 | ON-Q* Pump with Bolus | Halyard Health | 2019-03-22 |
| K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte. , Ltd. | 2016-04-04 |
| K131249 | ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES | I-Flow, LLC | 2014-02-03 |
| K131247 | MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM | Mfs - Medical Flow Systems, Ltd. | 2013-08-14 |
| K090300 | MODIFICATION TO AUTOFUSER | Ace Medical Us, LLC | 2009-04-30 |
| K081905 | ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP | Westmed, Inc. | 2008-07-15 |
| K071532 | ALPHA INFUSION PUMP, MODEL A200, A450 | Advanced Infusion, Inc. | 2008-02-19 |
| K072921 | DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM | Symbios Medical Products, LLC | 2007-11-26 |
| K072053 | SMARTBLOCK PAIN PUMP | Medical Flow Systems, Ltd. | 2007-11-06 |
| K071735 | MODIFICATION TO DISPOSABLE INFUSION PUMP KIT | Symbios Medical Products, LLC | 2007-07-19 |
| K071222 | INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES | Baxter Healthcare Corp | 2007-05-25 |
| K063530 | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP | I-Flow Corp. | 2007-01-26 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases