Disposable Temperature Probe Cover

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

510(k) Number

K801366 ↗

FDA Product Code

FLL

Device Class

Class II

Regulation

21 CFR Part 880.2910

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Vita/Trac 4 Function Vital Sign Monitor

  Class II

  FDA 510(k) K830916 Active Cleared 7 Jul 1983

• Pace-Pulse/Computrac

  Class II

  FDA 510(k) K800782 Active Cleared 28 May 1980

• Baro/Trac II & Vita/Trac, Vital Sign Mon

  Class II

  FDA 510(k) K801389 Active Cleared 28 Jul 1980

• Vita/Trac 4-Function Vital Sign Monitor

  Class II

  FDA 510(k) K800596 Active Cleared 21 Jul 1980

• What is the Disposable Temperature Probe Cover used for?

  It is intended to be placed over a temperature probe to create a barrier between the probe and the patient, maintaining hygiene and preventing cross-contamination during temperature measurement procedures.

• Is the Disposable Temperature Probe Cover sterile and for single-use only?

  Yes, the device is supplied sterile and designated for single-use only, as stated in the device description, to ensure infection control and prevent reuse-related contamination risks.

• What regulatory authorization does the Disposable Temperature Probe Cover have?

  It is authorized under FDA 510(k) clearance with K number K801366, indicating it was found substantially equivalent to a legally marketed predicate device through a traditional 510(k) submission.

• In what settings is the Disposable Temperature Probe Cover intended for use?

  The device is intended for use in general hospital settings, as specified in the device description and supported by the advisory committee classification of 'General Hospital' (HO).