Atlas FDA

LIFESHIELD EXTENSION SET

FDA 510(k) clearance K912103 · decided 1991-12-13

Clearance details

K-number
K912103
Device name
LIFESHIELD EXTENSION SET
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1991-05-13
Decision date
1991-12-13
Days to decision
214 days
Clearance type
Traditional
Product code
FPK
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Abbott Park, 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
MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING (K131517)Medrad, Inc. / Bayer Medical Care, Inc.2013-08-02
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES (K063114)Coeur, Inc.2007-02-09
LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 (K063239)Hospira, Inc.2006-12-11
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 (K052431)Medtronic Minimed2005-11-29
EMPOWER TRANSFER SET, (CAT. NO. 7725) (K041178)E-Z-Em, Inc.2004-07-16
MEDRAD SWABBABLE VALVE TRANSFER SET (K031808)Medrad, Inc.2003-07-11
MEDRAD TRANSFER SET (K022431)Medrad, Inc.2002-09-05
POLYFIN EXTENSION SET, MODELS 126 AND 128 (K965208)Medtronic Minimed1997-02-26
SILCLEAR TUBING (MODIFICATION) (K953864)Degania Silicone , Ltd.1995-11-06
SYSMEX SF-3000 (K950508)Sysmex Corp.1995-11-03
EXTENSION SET/I.V. SET (K952243)Coast Medical, Inc.1995-07-26
60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP (K952663)Distronic Sterile Products, Inc.1995-07-14

Recalls involving this device

RecordFirmDate
Lifeshield, latex-free, Secondary I.V. Set, convertible pin, 32 inch with OPTION-LOK, drop recall (Z-1388-2010)Hospira Inc.2010-04-15
Secondary I.V. Gravity Feed Sets; sterile, Rx, single use devices; Abbott Laboratories, No recall (Z-0959-03)Abbott Laboratories HPD/ADD2003-06-27

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