LGT TUBE

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K852413 ↗

FDA Product Code

BTO

Device Class

Class II

Regulation

21 CFR Part 868.5800

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Foam Nose

  Class I

  FDA 510(k) K840399 Active Cleared 16 Mar 1984

• Isotonic Diluent

  Class I

  FDA 510(k) K781008 Active Cleared 28 Jun 1978

• Hi-Lo Temp Thermocouple to Thermister Adaptor

  Class II

  FDA 510(k) K844201 Active Cleared 4 Mar 1985

• Glucose Reagent (O-Toluidine)

  Class II

  FDA 510(k) K771314 Active Cleared 3 Aug 1977

• Ria Quant C-Peptide Kit

  Class I

  FDA 510(k) K812689 Active Cleared 6 Oct 1981

• Hi-Lo Temp(R) Model 8700 Patient Temp Monitor

  Class II

  FDA 510(k) K874568 Active Cleared 6 Jan 1988

See all devices from Mallinckrodt Critical Care →

• What is the LGT TUBE used for?

  The LGT TUBE is a tracheostomy tube designed to establish and maintain an airway in patients who require a tracheostomy.

• Is the LGT TUBE intended for single or multiple use?

  The device is intended for single-use or multiple-use as determined by the healthcare provider, based on clinical judgment.

• What is the regulatory classification of the LGT TUBE?

  The LGT TUBE is classified as a Class II medical device in the anesthesiology specialty.