Posts Tagged Medical Products

King Systems Corresponds to the FDA Regarding KLT(S)D Labeling

Friday, January 22nd, 2010

To: King Systems Customers

Re: KING LT(S)-D™ Oropharyngeal Airway update

Dear Valued Customers,
As stated in our communication dated December 4, 2009, the FDA accepted our amended IFU (Instruction for Use) with the revised Indications and Contraindications (noted below) and as such we have continued shipment of product with the revised IFU and Labeling.

Please note that King Systems has taken the following actions associated with the KING LT Product:

• Amended IFU to align with cleared indications for use and the definition of an Oropharyngeal Airway in 21 CFR 868.5110. The revised indications and contraindications are:
  • Indications
    The KING LT(S)-D is indicated for airway management by providing a patent airway to allow patient ventilation.
  • Contraindications
    Responsive patients with an intact gag reflex.
    Patients with known esophageal disease.
    Patients who have ingested caustic substances.

    The KLT(S)-D is not proven to protect the airway from the effects of regurgitation and aspiration. The risk of regurgitation and aspiration must be weighed against the potential benefit of establishing an airway.

• Amended literature and labeling to remove all references to EMS, Emergency, Pre-hospital
• Revised IFU is being used with all inventory and ordered product at King Systems. The revised IFU is obvious in Form Number (Revision 12/09 or Later) and in defined Indications for Use.
• Revised IFU and Literature has been placed on www.www.kingsystems.com web page.

The KLTS-D/KLT-D 510(k) with broader Indications for the KLT product and defined intended use for difficult and emergency airways has been submitted to the FDA. We are pursuing all avenues to expedite its review and approval.

If you have questions, please email them to ltsd@www.kingsystems.com or contact me directly at 317-776-6823, extension 257.

Tags: Anesthesia, Medical Products
Posted in News Releases |

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