Atlas FDA

HOTLINE FLUID WARMER

FDA 510(k) clearance K911383 · decided 1991-10-17

Clearance details

K-number
K911383
Device name
HOTLINE FLUID WARMER
Applicant
Level 1 Technologies, Inc.
Decision
Substantially Equivalent
Date received
1991-03-28
Decision date
1991-10-17
Days to decision
203 days
Clearance type
Traditional
Product code
LGZ
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Potomac, MD, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fl recall (Z-2759-2026)ICU Medical Inc.2026-07-17
Smiths Medical HOTLINE Fluid Warming Set L-70. Product Usage: intended for the delivery of recall (Z-1443-2014)Smiths Medical ASD, Inc.2014-04-09
Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of recall (Z-1444-2014)Smiths Medical ASD, Inc.2014-04-09
Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: Th recall (Z-1979-2012)Smiths Medical ASD, Inc.2012-07-09
HOTLlNE Disposable Administration Sets, Product Codes L-70 Product Usage: Single patient u recall (Z-0422-2012)Smiths Medical ASD, Inc.2012-01-11
HOTLlNE Disposable Administration Sets, Product Codes L-70NI Product Usage: Single patient recall (Z-0423-2012)Smiths Medical ASD, Inc.2012-01-11
HOTLlNE Disposable Administration Sets, Product Code L-270 Product Usage: Single patient u recall (Z-0424-2012)Smiths Medical ASD, Inc.2012-01-11
HOTLlNE Disposable Administration Sets, Product Code L-370 Product Usage: Single patient u recall (Z-0425-2012)Smiths Medical ASD, Inc.2012-01-11
HOTLlNE Disposable Administration Sets, Product Code L-80 Product Usage: Single patient us recall (Z-0426-2012)Smiths Medical ASD, Inc.2012-01-11
Level 1 Normothermic I.V. Fluid Administration Sets, Product Code D-60HL , Product Usage: recall (Z-0427-2012)Smiths Medical ASD, Inc.2012-01-11
Level 1 Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL , Product Usage: recall (Z-0428-2012)Smiths Medical ASD, Inc.2012-01-11