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510(k) K042800

LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE by Hospira, Inc. — Product Code MEA

K042800 is an FDA 510(k) premarket notification submitted by Hospira, Inc. for the device "LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE". The FDA issued a decision of Substantially Equivalent on October 18, 2004. The device falls under product code MEA (Pump, Infusion, Pca), a Class II device regulated under 21 CFR 880.5725. Hospira, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2004
Date Received
October 8, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Pump, Infusion, Pca
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Hospira, Inc.

  • K161469 — Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (March 28, 2017)
  • K161036 — Hospira Extension Set, Hospira Primary Set (January 6, 2017)
  • K160492 — Hospira Sapphire Sets (December 6, 2016)
  • K160870 — Hospira Administration Sets (June 1, 2016)
  • K143612 — LifeCare PCA Infusion System (April 8, 2016)
  • K143087 — Hospira Blood Set (March 4, 2015)
  • K143015 — Hospira Primary Sets (February 25, 2015)
  • K141789 — PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODU (January 16, 2015)
  • K142622 — IV Administration (January 15, 2015)
  • K142974 — Extension Sets (January 9, 2015)

Other clearances for product code MEA

  • K162165 — ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Inte (August 29, 2017)
  • K170982 — CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis I (August 24, 2017)
  • K143612 — LifeCare PCA Infusion System (April 8, 2016)
  • K130394 — CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 (December 9, 2013)
  • K092313 — PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM (November 4, 2009)
  • K072144 — CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE (March 7, 2008)
  • K051253 — MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR (July 15, 2005)
  • K043299 — MEDLEY PCA MODULE, MODEL 8120 (December 10, 2004)
  • K043256 — HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTE (December 6, 2004)
  • K033054 — HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP (December 16, 2003)

FDA data resources