Fever Meter

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

510(k) Number

K821314 ↗

FDA Product Code

KDP

Device Class

Class II

Regulation

21 CFR Part 880.6740

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Clean Cuff Blood Pressure Cuff Liner

  Class II

  FDA 510(k) K925352 Active Cleared 12 Jan 1993

• Winter Head Dressing

  Class I

  FDA 510(k) K801458 Active Cleared 28 Jul 1980

• Zero-G(Tm) Gel/Foam Mattress Topper

  Class I

  FDA 510(k) K911843 Active Cleared 30 May 1991

• Mercury and Glass Fever Thermometer

  Class II

  FDA 510(k) K911269 Active Cleared 15 May 1991

• Zero-G

  Class I

  FDA 510(k) K842120 Active Cleared 8 Jun 1984

• What is the Fever Meter used for?

  The Fever Meter is a device used to measure body temperature. It is intended for use in general hospital settings, as indicated in its FDA 510(k) clearance documentation.

• How is the Fever Meter supplied or distributed?

  The device data does not specify how the Fever Meter is supplied, packaged, or distributed. Information about its supply chain, packaging, or delivery format is not included in the provided authorization or specification details.

• Is the Fever Meter sterile or single-use?

  The device data does not state whether the Fever Meter is sterile, single-use, or reusable. No information about sterility, reprocessing, or intended use duration is provided in the authorization records.

• What sizes or models of the Fever Meter are available?

  The device data does not list any specific sizes, models, or variations of the Fever Meter. Only the base device name 'FEVER METER' and its K-number K821314 are provided, with no additional model references or dimensional specifications.

• What are the storage requirements for the Fever Meter?

  The device data does not include any storage conditions, temperature requirements, or environmental specifications for the Fever Meter. No storage guidance is present in the authorization or specification fields.