MEA · Pump, Infusion, Pca
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | MEA |
|---|---|
| Device Name | Pump, Infusion, Pca |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K162165 | ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump | Summit Medical Products, Inc. | Aug 29, 2017 | SESE |
| K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) | Smiths Medical Ads, Inc. | Aug 24, 2017 | SESE |
| K143612 | LifeCare PCA Infusion System | Hospira, Inc. | Apr 8, 2016 | SESE |
| K130394 | CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 | Smiths Medical Asd, Inc. | Dec 9, 2013 | SESE |
| K092313 | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM | B.Braun Medical, Inc. | Nov 4, 2009 | SESE |
| K072144 | CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR | Smiths Medical MD, Inc. | Mar 7, 2008 | SESE |
| K051253 | MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) | Baxter Healthcare Corp | Jul 15, 2005 | SESE |
| K043299 | MEDLEY PCA MODULE, MODEL 8120 | Alaris Medical Systems, Inc. | Dec 10, 2004 | SESE |
| K043256 | HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 | Hospira, Inc. | Dec 6, 2004 | SESE |
| K042800 | LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | Hospira, Inc. | Oct 18, 2004 | SESE |
| K033054 | HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP | Harvard Clinical Technology | Dec 16, 2003 | SESE |
| K032233 | MEDLEY PCA MODULE, MODEL 8120 | Alaris Medical Systems, Inc. | Sep 9, 2003 | SESE |
| K031566 | SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 | Baxter Healthcare Corp | Aug 19, 2003 | SESE |
| K030661 | STRYKER PAINPUMP2 | Stryker Instruments | May 30, 2003 | SESE |
| K020421 | GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES | Hennig Enterprises Europe Srl | Apr 29, 2003 | SESE |
| K020418 | GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES | P.T. Greenleaf | Apr 29, 2003 | SESE |
| K022203 | ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 | Abbott Laboratories | Aug 1, 2002 | SESE |
| K013822 | MICROJET CRONO PCA | Cane S.R.L. | May 8, 2002 | SESE |
| K002739 | INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K | Baxter Healthcare Corp | Sep 11, 2000 | SESE |
| K002434 | PALM PUMP | Sorenson Medical, Inc. | Aug 23, 2000 | SESE |
Top Applicants
- Baxter Healthcare Corp — 3 clearances
- Hospira, Inc. — 3 clearances
- Alaris Medical Systems, Inc. — 2 clearances
- C.R. Bard, Inc. — 2 clearances
- Pharmacia Deltec, Inc. — 2 clearances
