Atlas FDA

PALM PUMP

FDA 510(k) clearance K002434 · decided 2000-08-23

Clearance details

K-number
K002434
Device name
PALM PUMP
Applicant
Sorenson Medical, Inc.
Decision
Substantially Equivalent
Date received
2000-08-09
Decision date
2000-08-23
Days to decision
14 days
Clearance type
Special
Product code
MEA
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
West Jordan, UT, 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
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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
ambIT Ambulatory Infusion Pump Cassette; Filterless, Spike, Sterile, Vol. 2.3ml, REF 22013 recall (Z-0185-2007)Sorenson Medical, Inc.2006-11-16
ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, S recall (Z-0186-2007)Sorenson Medical, Inc.2006-11-16
ambIT Ambulatory Infusion Pump Cassette; Filter, Male, Sterile, Vol. 2.3ml, REF 220266, So recall (Z-0187-2007)Sorenson Medical, Inc.2006-11-16
ambIT Ambulatory Infusion Pump Cassette; Filterless, Male, Sterile, Vol. 2.3ml, REF 220267 recall (Z-0188-2007)Sorenson Medical, Inc.2006-11-16