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Affinity Temperature Probe

by Medtronic, Inc.

510(k) K160091

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160091↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK160091 Date20 May 2016ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Temperature Probe, Affinity Temperature Probe
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, 18 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 Affinity Temperature Probe is a medical device classified as a temperature measurement probe (FDA Product Code: FLL), designed for accurate and precise monitoring of body temperature in clinical settings. It is intended for use with patient monitoring systems to provide real-time thermal data, ensuring reliable assessment of physiological temperature during medical procedures or patient care.

This probe is supplied sterile and intended for single-use, adhering to standard hospital infection control protocols. It is compatible with MRI environments, as indicated by its design and regulatory submissions, and is available in a standardized configuration as specified in the device documentation. Authorized for use in the United States under FDA 510(k) clearance (K160091) and compliant with EU MDR requirements, it is distributed for clinical use in general hospital settings.

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