Atlas FDA

BODYGUARD INFUSION PUMP SYSTEM

FDA 510(k) clearance K042696 · decided 2005-03-11

Clearance details

K-number
K042696
Device name
BODYGUARD INFUSION PUMP SYSTEM
Applicant
Caesarea Medical Electronics , Ltd.
Decision
Substantially Equivalent
Date received
2004-09-30
Decision date
2005-03-11
Days to decision
162 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Caesarea, IL
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
BodyGuard BodySet, REF: A120-160SAS recall (Z-2553-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A120-160XPS recall (Z-2554-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A100-163XESV recall (Z-2555-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A100-163XES recall (Z-2556-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A120-161XPS recall (Z-2557-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A120-160XSFK recall (Z-2558-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A120-112XSFK recall (Z-2559-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A100-163XSFL recall (Z-2560-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A120-160XYSF recall (Z-2561-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A120-161XYB recall (Z-2562-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A120-161XYBS recall (Z-2563-2020)CME America, LLC2020-07-15
BodyGuard Microset with Filter, REF: A100-163XESF recall (Z-2564-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A120-161XPSV recall (Z-2565-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A120-160X2YB recall (Z-2566-2020)CME America, LLC2020-07-15
BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY recall (Z-2567-2020)CME America, LLC2020-07-15
CMExpress Microbore Set, REF: A120-160CRV recall (Z-2568-2020)CME America, LLC2020-07-15
CMExpress Microbore Set, REF: A120-161CYF recall (Z-2569-2020)CME America, LLC2020-07-15
BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS recall (Z-2570-2020)CME America, LLC2020-07-15
BodyGuard Microset with Filter, REF: A120-160XSFE recall (Z-2571-2020)CME America, LLC2020-07-15
BodyGuard Microset with Filter, REF: A100-164XESF recall (Z-2572-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A100-163XE90S recall (Z-2573-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A100-163XSL recall (Z-2574-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A120-003XS2YV recall (Z-2575-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A120-125XSE recall (Z-2576-2020)CME America, LLC2020-07-15
BodyGuard Microset, REF: A120-160GCFA recall (Z-2577-2020)CME America, LLC2020-07-15
CMExpress Microbore Sets, REF: A120-160CYFRV recall (Z-2578-2020)CME America, LLC2020-07-15
CMExpress Microbore Sets, REF: A120-160C2YRV recall (Z-2579-2020)CME America, LLC2020-07-15
CMExpress Microbore Sets, REF: A120-161C recall (Z-2580-2020)CME America, LLC2020-07-15
BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF recall (Z-2581-2020)CME America, LLC2020-07-15
BodyGuard set with Female Luer, REF: A120-003XSN recall (Z-2582-2020)CME America, LLC2020-07-15
BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV recall (Z-2583-2020)CME America, LLC2020-07-15
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF recall (Z-2584-2020)CME America, LLC2020-07-15
Standard BodySet with Needleless Connectors, REF: A120-125XS recall (Z-2585-2020)CME America, LLC2020-07-15
CMExpress Microbore Set, REF: A120-160C recall (Z-2586-2020)CME America, LLC2020-07-15
CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK recall (Z-2587-2020)CME America, LLC2020-07-15
BodyGuard Microset With Female Luer, REF: A120-160XPSN recall (Z-2588-2020)CME America, LLC2020-07-15
BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV recall (Z-2589-2020)CME America, LLC2020-07-15
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: appr recall (Z-1442-2020)CME America, LLC2020-03-11
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and recall (Z-1126-2015)CME America, LLC2015-02-19