Skip to content

Disposable Temperature Probe

by Shiley, Inc. 510(k)

Active United States

510(k) K821244

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821244 Date14 May 1982ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 24 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 Disposable Temperature Probe is a continuous measurement thermometer designed to monitor body temperature. It functions as a clinical electronic thermometer for use in general hospital settings.

This device is supplied as a single-use product under FDA 510(k) clearance K821244. It is classified as a Class 2 medical device and is regulated under 880.2910.

Other devices from Shiley, Inc.

See all devices from Shiley, Inc. →