Skip to content

Hitachi Electronic Thermometer Model HK-10TA

by Hitachi Sales Corporation of America

510(k) K864089

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK864089 Date7 Nov 1986ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an electronic clinical thermometer, as defined by its device type and product code FLL. It is designed for measuring body temperature in a general hospital setting.

The device was cleared through the FDA 510(k) process under K864089 with a traditional clearance type and a substantially equivalent decision. It is supplied as a non-sterile, reusable electronic thermometer intended for use in general hospital environments, with no indications of sterility, single-use designation, MRI safety, or specific storage conditions provided in the data.

Other devices from Hitachi Sales Corporation of America

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Hitachi HK-10TA electronic thermometer used for?

    The Hitachi HK-10TA is designed for measuring body temperature in a general hospital setting, as defined by its device type and product code FLL, with no additional clinical indications specified in the data.

  • Is the Hitachi HK-10TA sterile or single-use?

    The device is supplied as non-sterile and reusable, with no indications of sterility, single-use designation, or specific storage conditions provided in the authorization data.

  • How was the Hitachi HK-10TA cleared for market?

    The device received FDA 510(k) clearance under K864089 on November 7, 1986, through a traditional review process with a substantially equivalent decision based on predicate device comparison.