Atlas FDA

BARD PCA II PUMP WITH PROGRAM CARTRIDGES

FDA 510(k) clearance K914502 · decided 1991-12-18

Clearance details

K-number
K914502
Device name
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
Applicant
C.R. Bard, Inc.
Decision
Substantially Equivalent
Date received
1991-10-09
Decision date
1991-12-18
Days to decision
70 days
Clearance type
Traditional
Product code
MEA
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
North Reading, MA, 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
LifeCare PCA Infusion System (K143612)Hospira, Inc.2016-04-08
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

Recalls involving this device

RecordFirmDate
Baxter PCA II Syringe Infusion Pump, product codes 2L3104 and 2L3104R; Baxter Healthcare C recall (Z-0553-06)Baxter Healthcare Corp.2006-04-26

PMA approvals by this applicant

RecordFirmDate
Covera™ Vascular Covered Stent (P170042/S014)C.R. Bard, Inc.2025-12-16
Covera™ Vascular Covered Stents (P170042/S013)C.R. Bard, Inc.2025-06-26
Avitene Microfibrillar Collagen Hemostat (P800002/S033)C.R. Bard, Inc.2025-03-13
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032)C.R. Bard, Inc.2025-02-18
Avitene™ Bulk Flour Cleanroom Expansion (P800002/S031)C.R. Bard, Inc.2024-01-18
Avitene™ Microfibrillar Collagen Hemostat (P800002/S030)C.R. Bard, Inc.2023-10-04
Covera™ Vascular Covered Stent (P170042/S012)C.R. Bard, Inc.2023-02-02
Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027)C.R. Bard, Inc.2022-04-01