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ri-former Predictive Thermometer

by Rudolf Riester GmbH & Co. KG

510(k) K171182

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 NumberK171182 Date4 Oct 2017ClearedStatusActive

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  • Withdrawn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
FDA applicant
Rudolf Riester GmbH
Device class
Class II
Regulation
21 CFR Part 880.2910
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

The ri-former Predictive Thermometer is a clinical instrument for measuring patient temperature via oral, axillary, or rectal probes. It is designed to integrate with the ri-former diagnostic station for power.

The device is supplied as a reusable instrument and is authorized under FDA 510(k) clearance (K171182). It is manufactured by Rudolf Riester GmbH and intended for use in clinical settings where temperature measurement is required.

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Questions

AI-generated answers, 27 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 ri-former Predictive Thermometer used for?

    The ri-former Predictive Thermometer is a clinical instrument used to measure patient temperature via oral, axillary, or rectal probes. It is intended for use in clinical settings where temperature measurement is required, providing a reusable option for routine vital sign monitoring.

  • How is the ri-former Predictive Thermometer supplied and powered?

    The device is supplied as a reusable instrument and is designed to integrate with the ri-former diagnostic station for power. It does not operate independently but draws power from the connected diagnostic station when in use.

  • Is the ri-former Predictive Thermometer single-use or reusable?

    The ri-former Predictive Thermometer is supplied as a reusable instrument, meaning it is designed for multiple uses after proper cleaning and disinfection between patients, in accordance with the manufacturer’s instructions for reuse.

  • What regulatory authorization does the ri-former Predictive Thermometer have?

    The ri-former Predictive Thermometer is authorized under FDA 510(k) clearance (K171182), indicating it was found substantially equivalent to a legally marketed predicate device. This clearance is explicitly stated in the device data.