Medley System with Medication Management System (MMS)
FDA 510(k) K030459 · Alaris Medical Systems, Inc.
510(k) numberK030459
Submission
- Device name
- Medley System with Medication Management System (MMS)
- Applicant
- Alaris Medical Systems, Inc.
San Diego, CA, US - Received
- February 11, 2003
- Decision date
- April 4, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K242115 | Plum Duo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
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More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K043299 | Medley Pca Module, Model 8120MEA · Traditional | 12/10/2004SE |
| K041241 | Medley System with Bar Code Module, Model 8600FRN · Traditional | 07/06/2004SE |
| K031741 | Medley ETCO2 Module (Includes Accessories), Model 8300CCK · Traditional | 02/09/2004SE |
| K032233 | Medley Pca Module, Model 8120MEA · Traditional | 09/09/2003SE |
| K032147 | Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX…FRN · Special | 07/25/2003SE |
| K023264 | Medley Syringe Pump Module System, Model 8110FRN · Traditional | 12/19/2002SE |
| K022677 | Medley SPO2 Module, Model 8210 & SPO2 Sensors & CableDQA · Special | 09/11/2002SE |
| K022209 | Alaris Medical Infusion System Administration SetsFPA · Special | 08/06/2002SE |
| K013087 | Single Dose Dispensing Pin, Model 2201LHI · Traditional | 11/13/2001SE |
| K012383 | Gemini PC-1,PC-2, PC-2TX,PC-4, Signature Edition Infusion Pump (Se), Medsystem III…FRN · Traditional | 10/02/2001SE |
Questions and answers
When was Medley System with Medication Management System (MMS) cleared by the FDA?
Medley System with Medication Management System (MMS) (K030459) received a 510(k) decision of Substantially Equivalent on April 4, 2003, 52 days after the submission was received.
What is the product code of K030459?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.