King LT not approved by FDA for Prehospital marketing.

FFMedic75

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Has anyone heard this? Apparently they have been ordered to stop marketing it in this manner. These devices have become popular recently as backup devices and for use by basic providers. SC DHEC is currently allowing there continued use until the FDA's position is clarified.
 
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FFMedic75

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Here is a copy of the letter.
 

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  • King Systems Warning Letter 10-06-09.pdf
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reaper

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That is for the King LT-D. SC uses the King LT.

It is approved for weight based use, not height based. That is the problem with their literature.
 

firetender

Community Leader Emeritus
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Interested in hearing from users of it if the King airway is any real improvement over the old Esophageal Obturator Airway (EOA) and what value it has, if any, over good old Endotracheal Intubation.

Just a curious dinosaur
 

reaper

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The King LT is a great device. IMHO it is superior to an LMA or Combietube. The ease of installation makes it a great airway for EMT's.

BTW- a straw stuck down their throat is better then an EOA! :) God how I hated those things.
 

VentMedic

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BTW- a straw stuck down their throat is better then an EOA! :) God how I hated those things.

I believe that those of us from the 70s and early 80s who had the EOA as our backup airway became extremely proficient in the use of the BVM and ETI because of it. Anything but the EOA! I also put the Combitube on my list of least desirable devices to use on a patient.
 

Markhk

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Despite KING Systems getting the warning letter, there still wouldn't be any restrictions on the sale of the devices for EMS since the medical direction doc can purchase or prescribe medical devices "off label". (Similar to how we get to use Versed intransally.)

Beyond the height issue, the King airway was licensed for a patient with "low risk of aspiration" in addition to being used specifically for anesthesia application. The FDA has issue with it being marketed as an "emergent airway" device.
 

Pudge40

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A paramedic that I run with is in charge of a paramedic program at the local hospital. He has told me that he thinks that the S.A.L.T will be the wave of the future.
 
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