Atlas FDA

DIALYSIS TRAY

FDA 510(k) clearance K841124 · decided 1984-04-20

Clearance details

K-number
K841124
Device name
DIALYSIS TRAY
Applicant
Medcare Products
Decision
Substantially Equivalent
Date received
1984-03-15
Decision date
1984-04-20
Days to decision
36 days
Clearance type
Traditional
Product code
KOC
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mchenry, 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
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) (K242176)NIKKISO CO., LTD.2025-05-15
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU (K242479)NIKKISO CO., LTD.2025-05-15
Blood Tubing Lines for Hemodialysis AV06C-E (K231589)NIKKISO CO., LTD.2023-07-28
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CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line (K201207)Fresenius Medical Care Renal Therapies Group, LLC2020-09-18
CAREline Airless Hemodialysis Blood Tubing Sets (K172238)Fresenius Medical Care Renal Therapies Group, LLC2017-12-14
CRIT-LINE III Blood Chamber II (K160749)Fresenius Medical Care Renal Therapies Group, LLC2016-04-15
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (K152953)Fresenius Medical Care North America2015-11-05
CRIT-LINE IV SYSTEM (K141997)Fresenius Medical Care2015-04-01
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CRIT-LINE CLIP (CLIC) (K121599)Fresenius Medical Care-North America2012-11-09
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Recalls involving this device

No recalls on record reference this clearance.