Product code MEA— General Hospital
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
- Classification name
- Pump, Infusion, Pca
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Total cleared
- 31
- First cleared
- Most recent
Market context for product code MEA
FDA has cleared devices under product code MEA between 1991 and 2017, filed by 24 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2017
- 2016
- 2013
- 2009
- 2008
- 2005
- 2004
- 2003
- 2002
- 2000
- 1999
- 1998
- 1995
- 1994
- 1993
Top applicants under product code MEA
Adverse events under product code MEA
product code MEA- Death
- 19
- Malfunction
- 25,089
- Total
- 25,108
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MEA
- K162165 — ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
- K170982 — CADD®- Solis Ambulatory Infusion Pump with Wireless Communication +4 more
- K143612 — LifeCare PCA Infusion System
- K130394 — CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
- K092313 — PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
- K072144 — CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR
- K051253 — MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
- K043299 — MEDLEY PCA MODULE, MODEL 8120
- K043256 — HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03
- K042800 — LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
- K033054 — HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
- K032233 — MEDLEY PCA MODULE, MODEL 8120
- K031566 — SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
- K030661 — STRYKER PAINPUMP2
- K020418 — GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
- K020421 — GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
- K022203 — ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
- K013822 — MICROJET CRONO PCA
- K002739 — INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
- K002434 — PALM PUMP
- K990312 — AVIA PAIN MEDICATION DELIVERY SYSTEM
- K982839 — CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
- K943310 — MODEL 6100 AMBULATORY INFUSION SYSTEM
- K934551 — VERIFUSE AMBULATORY PUMP
- K920637 — PRIME PCA AND PCA/CONTINUOUS SYSTEMS
- K915270 — PATIENT CONTROLLED SYRINGE PUMP TYPE 3300
- K921994 — BARD PCA II PUMP WITH PROGRAM CARTRIDGES
- K915063 — IVAC PC ANIFUSER
- K914502 — BARD PCA II PUMP WITH PROGRAM CARTRIDGES
- K910257 — BAXA PCA INFUSOR
- K911791 — CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP
Data sourced from openFDA. This site is unofficial and independent of the FDA.