Atlas FDA

LifeCare PCA Infusion System

FDA 510(k) clearance K143612 · decided 2016-04-08

Clearance details

K-number
K143612
Device name
LifeCare PCA Infusion System
Applicant
Hospira, Inc.
Decision
Substantially Equivalent
Date received
2014-12-19
Decision date
2016-04-08
Days to decision
476 days
Clearance type
Traditional
Product code
MEA
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Lake Forest, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump (K162165)Summit Medical Products, Inc.2017-08-29
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) (K170982)Smiths Medical Ads, Inc.2017-08-24
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 (K130394)Smiths Medical Asd, Inc.2013-12-09
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM (K092313)B.Braun Medical, Inc.2009-11-04
CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR (K072144)Smiths Medical MD, Inc.2008-03-07
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) (K051253)Baxter Healthcare Corp2005-07-15
MEDLEY PCA MODULE, MODEL 8120 (K043299)Alaris Medical Systems, Inc.2004-12-10
HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 (K043256)Hospira, Inc.2004-12-06
LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (K042800)Hospira, Inc.2004-10-18
HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP (K033054)Harvard Clinical Technology2003-12-16
MEDLEY PCA MODULE, MODEL 8120 (K032233)Alaris Medical Systems, Inc.2003-09-09
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 (K031566)Baxter Healthcare Corp2003-08-19

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S008)Hospira, Inc.1999-01-29
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S007)Hospira, Inc.1996-09-05
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S006)Hospira, Inc.1996-01-04
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S003)Hospira, Inc.1995-12-15
DEXTRAN HM 32 (P880028/S002)Hospira, Inc.1990-11-15
DEXTRAN HM 32 (P880028/S001)Hospira, Inc.1989-12-29
DEXTRAN HM 32% (P880028)Hospira, Inc.1989-05-30