Medley Pca Module, Model 8120
FDA 510(k) K032233 · Alaris Medical Systems, Inc.
510(k) numberK032233
Submission
- Device name
- Medley Pca Module, Model 8120
- Applicant
- Alaris Medical Systems, Inc.
San Diego, CA, US - Received
- July 21, 2003
- Decision date
- September 9, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEA – Pump, Infusion, Pca
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code MEA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162165 | ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent…MEA · Traditional | Summit Medical Products, Inc. | 08/29/2017SE |
| K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion…MEA · Traditional | Smiths Medical Ads, Inc. | 08/24/2017SE |
| K143612 | LifeCare PCA Infusion SystemMEA · Traditional | Hospira, Inc. | 04/08/2016SE |
| K130394 | Cadd -Solis Ambulatory Infusion Pump, Version 3.0MEA · Traditional | Smiths Medical Asd, Inc. | 12/09/2013SE |
| K092313 | Perfusor Space Infusion Syringe Pump SystemMEA · Traditional | B.Braun Medical, Inc. | 11/04/2009SE |
| K072144 | Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software -…MEA · Traditional | Smiths Medical MD, Inc. | 03/07/2008SE |
| K051253 | Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with…MEA · Traditional | Baxter Healthcare Corp | 07/15/2005SE |
| K043299 | Medley Pca Module, Model 8120MEA · Traditional | Alaris Medical Systems, Inc. | 12/10/2004SE |
| K043256 | Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System…MEA · Special | Hospira, Inc. | 12/06/2004SE |
| K042800 | Lifecare Pca Infusion System with Hospira Mednet SoftwareMEA · Traditional | Hospira, Inc. | 10/18/2004SE |
More from Hospira, Inc.
| 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 |
| K032147 | Signature Edition Infusion Pump, Signature Edition Administration Sets, Models 70XX…FRN · Special | 07/25/2003SE |
| K030459 | Medley System with Medication Management System (MMS)FRN · Traditional | 04/04/2003SE |
| 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 Pca Module, Model 8120 cleared by the FDA?
Medley Pca Module, Model 8120 (K032233) received a 510(k) decision of Substantially Equivalent on September 9, 2003, 50 days after the submission was received.
What is the product code of K032233?
The FDA product code is MEA – Pump, Infusion, Pca, a Class II (moderate risk) device regulated under 21 CFR 880.5725.