LifeCare PCA Infusion System
FDA 510(k) K143612 · Hospira, Inc.
510(k) numberK143612
Submission
- Device name
- LifeCare PCA Infusion System
- Applicant
- Hospira, Inc.
Lake Forest, IL, US - Received
- December 19, 2014
- Decision date
- April 8, 2016
- 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 |
| 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 |
| K033054 | Harvard 1 Syringe Pump/Harvard 1 with Pca Syringe PumpMEA · Traditional | Harvard Clinical Technology | 12/16/2003SE |
More from Harvard Clinical Technology
| 510(k) | Device | Decision |
|---|---|---|
| K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleFRN · Traditional | 03/28/2017SE |
| K161036 | Hospira Extension Set, Hospira Primary SetFPA · Traditional | 01/06/2017SE |
| K160492 | Hospira Sapphire SetsMRZ · Traditional | 12/06/2016SE |
| K160870 | Hospira Administration SetsFPA · Special | 06/01/2016SE |
| K143087 | Hospira Blood SetFPA · Traditional | 03/04/2015SE |
| K143015 | Hospira Primary SetsFPA · Traditional | 02/25/2015SE |
| K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play Ce 3.0 Module for…FRN · Traditional | 01/16/2015SE |
| K142622 | IV AdministrationFPA · Traditional | 01/15/2015SE |
| K142974 | Extension SetsFPA · Traditional | 01/09/2015SE |
| K142433 | Hospira Extension SetFPA · Traditional | 12/08/2014SE |
Questions and answers
When was LifeCare PCA Infusion System cleared by the FDA?
LifeCare PCA Infusion System (K143612) received a 510(k) decision of Substantially Equivalent on April 8, 2016, 476 days after the submission was received.
What is the product code of K143612?
The FDA product code is MEA – Pump, Infusion, Pca, a Class II (moderate risk) device regulated under 21 CFR 880.5725.