MEA — Pump, Infusion, Pca Class II
FDA Device Classification
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 |