Atlas FDA

HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE

FDA 510(k) clearance K041550 · decided 2004-06-30

Clearance details

K-number
K041550
Device name
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2004-06-09
Decision date
2004-06-30
Days to decision
21 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Abbott Park, IL, US
Third-party review
Yes
Expedited review
No

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Plum Solo™ Precision IV Pump (K242114)Icu Medical, Inc.2025-04-02
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Recalls involving this device

RecordFirmDate
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. flu recall (Z-0069-2013)Hospira Inc.2012-10-19
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. flu recall (Z-0070-2013)Hospira Inc.2012-10-19
Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List N recall (Z-0127-2011)Hospira Inc2010-10-22
Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser, List recall (Z-0128-2011)Hospira Inc2010-10-22
Hospira brand Symbiq One-Channel Infuser LIST No. 16026 Symbiq One-Channel Infuser, List N recall (Z-2390-2010)Hospira Inc2010-09-09
Hospira brand Symbiq Two-Channel Infuser, LIST No. 16027 Symbiq Two-Channel Infuser, List recall (Z-2391-2010)Hospira Inc2010-09-09
Hospira Inc. Symbiq One- and Two- Channel Infuser, List Numbers 16026 and 16027 respective recall (Z-2381-2010)Hospira Inc2010-09-08
Hospira brand Symbiq One-Channel Infuser; List Number: 16026; Distributed by: Hospira, Inc recall (Z-1894-2010)Hospira Inc2010-07-02
Hospira brand Symbiq Two-Channel Infuser; List Number: 16027; Distributed by: Hospira, Inc recall (Z-1895-2010)Hospira Inc2010-07-02
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CL recall (Z-1045-2010)Hospira Inc.2010-03-09
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CL recall (Z-1046-2010)Hospira Inc.2010-03-09
Latex-Free Symbiq Pump Set, convertible pin, 104.5 inch with Polyethylene-Lined tubing, ba recall (Z-1047-2010)Hospira Inc.2010-03-09
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CL recall (Z-1048-2010)Hospira Inc.2010-03-09
Latex-Free Symbiq Pump Set, convertible pin, 106 inch, piggyback with backcheck valve, 3 C recall (Z-1049-2010)Hospira Inc.2010-03-09
Latex-Free Symbiq Pump Set, convertible pin, 104 inch piggyback with backcheck valve, 2 CL recall (Z-1050-2010)Hospira Inc.2010-03-09
Latex-Free Symbiq Pump Set, convertible pin, 106 inch, piggyback with backcheck valve, 3 p recall (Z-1051-2010)Hospira Inc.2010-03-09
Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 pr recall (Z-1052-2010)Hospira Inc.2010-03-09
Latex-Free Symbiq Pump Set, convertible pin, 104 inch piggyback with backcheck valve, 2 pr recall (Z-1053-2010)Hospira Inc.2010-03-09
Primary Symbiq Set, Latex-Free with Polyethylene Lined Tubing, 2 CLAVE Y-sites, backcheck recall (Z-1054-2010)Hospira Inc.2010-03-09
Primary Symbiq Pump Set, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, Latex-Free, recall (Z-1055-2010)Hospira Inc.2010-03-09
Primary Latex-Free Symbiq Pump Set, piggyback with backcheck valve, 2 prepierced Y-sites, recall (Z-1056-2010)Hospira Inc.2010-03-09
Primary Symbiq Pump Set, piggyback with backcheck valve, 2 prepierced sites, 105 inch, Lat recall (Z-1057-2010)Hospira Inc.2010-03-09
Latex-Free Primary Symbiq Pump Set, piggyback with backcheck valve, 2 CLAVE Y-sites, 105 i recall (Z-1058-2010)Hospira Inc.2010-03-09
Primary Symbiq Set, Latex-Free, Polyethylene-Lined tubing, piggyback with backcheck valve, recall (Z-1059-2010)Hospira Inc.2010-03-09
Primary Symbiq Set, Latex-Free piggyback with backcheck valve, 3 prepierced Y-sites, 106 I recall (Z-1060-2010)Hospira Inc.2010-03-09
Primary Symbiq Set, 2 CLAVE Y-sites, backcheck valve, Latex-Free, non-DEHP, 20 drops/mL; a recall (Z-1061-2010)Hospira Inc.2010-03-09
Primary Symbiq Set, 2 CLAVE Y-sites, backcheck valve, 0.2 micron filter, Latex-Free, non-D recall (Z-1062-2010)Hospira Inc.2010-03-09
Symbiq Pump Set, detachable, convertible pin piggyback w/backcheck valve, 3 prepierced res recall (Z-1063-2010)Hospira Inc.2010-03-09
LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced Y-S recall (Z-0808-2010)Hospira Inc.2010-02-22
Hospira Phoenix Infusion System with MedNet Software, Symbiq One-Channel Infusion System, recall (Z-1815-2009)Hospira Inc2009-08-11
Hospira Phoenix Infusion System with MedNet Software, Symbiq Two-Channel Infusion System, recall (Z-1816-2009)Hospira Inc2009-08-11
Symbiq One-Channel list number 16026-04 and Two-Channel list number 16027-04 Infusion Syst recall (Z-0944-2009)Hospira Inc2009-02-27

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30