Modification to Autofuser
FDA 510(k) K090300 · Ace Medical Us, LLC
510(k) numberK090300
Submission
- Device name
- Modification to Autofuser
- Applicant
- Ace Medical Us, LLC
Powell, OH, US - Received
- February 6, 2009
- Decision date
- April 30, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEB – Pump, Infusion, Elastomeric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code MEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250234 | SMARTeZ Elastomeric Infusion Pump (RS series)MEB · Traditional | Epic Medical Pte. , Ltd. | 04/24/2026SE |
| K240624 | InfuLifeMEB · Traditional | First Medical Source, LLC | 11/05/2024SE |
| K242152 | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)MEB · Special | Epic Medical Pte. , Ltd. | 10/07/2024SE |
| K181360 | ON-Q* Pump with BolusMEB · Traditional | Halyard Health | 03/22/2019SE |
| K151650 | SMARTez elastomeric infusion pumpMEB · Traditional | Epic Medical Pte. , Ltd. | 04/04/2016SE |
| K131249 | On-Q Painbuster, On-Q C-Bloc, Homepump Eclipse, Homepump C-SeriesMEB · Traditional | I-Flow, LLC | 02/03/2014SE |
| K131247 | Multibolus II Disposable Pain Management SystemMEB · Traditional | Mfs - Medical Flow Systems, Ltd. | 08/14/2013SE |
| K081905 | Accuflow and Accuflux Elastomeric Infusion PumpMEB · Traditional | Westmed, Inc. | 07/15/2008SE |
| K071532 | Alpha Infusion Pump, Model A200, A450MEB · Traditional | Advanced Infusion, Inc. | 02/19/2008SE |
| K072921 | Disposable Infusion Pump Kit, Go Pump Rapid Recovery SystemMEB · Special | Symbios Medical Products, LLC | 11/26/2007SE |
More from Symbios Medical Products, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K060258 | AutofuserMEB · Traditional | 05/30/2006SE |
Questions and answers
When was Modification to Autofuser cleared by the FDA?
Modification to Autofuser (K090300) received a 510(k) decision of Substantially Equivalent on April 30, 2009, 83 days after the submission was received.
What is the product code of K090300?
The FDA product code is MEB – Pump, Infusion, Elastomeric, a Class II (moderate risk) device regulated under 21 CFR 880.5725.