5 Sec Digital Clinical Thermometer, Models ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X

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

510(k) Number

K050303 ↗

FDA Product Code

FLL

Models / Variants

ST8630X

ST8640X

ST8730X

ST8740X

ST8930X

ST8940X

ST8030X

ST8040X.

Device Class

Class II

Regulation

21 CFR Part 880.2910

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• 10-Second Digital Thermometer, Models ST87, ST89, ST80, ST88

  Class II

  FDA 510(k) K041056 Active Cleared 12 May 2004

• Thermometer Models ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, and ST8542F

  Class II

  FDA 510(k) K013779 Active Cleared 29 Mar 2002

• Ear Thermometer Models ST61, ST62, ST63, ST64, and ST65

  Class II

  FDA 510(k) K042627 Active Cleared 18 Oct 2004

• Wireless Temperature Monitor / Models ST323C and ST323F.

  Class II

  FDA 510(k) K063542 Active Cleared 10 Apr 2007

• Digital Clinical Thermometer St-813A, St-814A, St-823 and St-823A

  Class II

  FDA 510(k) K962520 Active Cleared 12 Sep 1996

• Ear Thermometer, Models ST613C and ST613F

  Class II

  FDA 510(k) K011254 Active Cleared 10 Jul 2001

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• What is the 5 SEC DIGITAL CLINICAL THERMOMETER used for?

  It is designed for measuring body temperature in general hospital settings, providing a reading in approximately five seconds as a reusable clinical device.

• How is the 5 SEC DIGITAL CLINICAL THERMOMETER supplied and is it reusable?

  The device is supplied as a reusable clinical thermometer, meaning it is intended for multiple uses after proper cleaning and disinfection between patients.

• What models are included in the 5 SEC DIGITAL CLINICAL THERMOMETER product line?

  The product line includes the following models: ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, and ST8040X, all sharing the same core functionality and design.

• What standard was the 5 SEC DIGITAL CLINICAL THERMOMETER designed and verified to?

  The device was designed and verified according to the US standard ASTM E 1112-00, which establishes performance requirements for electronic clinical thermometers.

• What regulatory pathway was used for the 5 SEC DIGITAL CLINICAL THERMOMETER?

  The device received FDA 510(k) clearance, demonstrating it is substantially equivalent to a legally marketed predicate device under product code FLL.