MEA — Pump, Infusion, Pca Class II
FDA product code MEA covers "Pump, Infusion, Pca", a Class II medical device regulated under 21 CFR 880.5725. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MEA
- Device Class
- Class II
- Regulation Number
- 880.5725
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K162165 | summit medical products | ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Inte | August 29, 2017 |
| K170982 | smiths medical ads | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis I | August 24, 2017 |
| K143612 | hospira | LifeCare PCA Infusion System | April 8, 2016 |
| K130394 | smiths medical asd | CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 | December 9, 2013 |
| K092313 | b.braun medical | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM | November 4, 2009 |
| K072144 | smiths medical md | CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE | March 7, 2008 |
| K051253 | baxter healthcare | MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR | July 15, 2005 |
| K043299 | alaris medical systems | MEDLEY PCA MODULE, MODEL 8120 | December 10, 2004 |
| K043256 | hospira | HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTE | December 6, 2004 |
| K042800 | hospira | LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | October 18, 2004 |
| K033054 | harvard clinical technology | HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP | December 16, 2003 |
| K032233 | alaris medical systems | MEDLEY PCA MODULE, MODEL 8120 | September 9, 2003 |
| K031566 | baxter healthcare | SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 | August 19, 2003 |
| K030661 | stryker instruments | STRYKER PAINPUMP2 | May 30, 2003 |
| K020418 | p.t. greenleaf | GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES | April 29, 2003 |
| K020421 | hennig enterprises europe | GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES | April 29, 2003 |
| K022203 | abbott laboratories | ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 | August 1, 2002 |
| K013822 | cane | MICROJET CRONO PCA | May 8, 2002 |
| K002739 | baxter healthcare | INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K | September 11, 2000 |
| K002434 | sorenson medical | PALM PUMP | August 23, 2000 |