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Pro Check Digital Pacifier Thermometer

by Micro Weiss Electronics 510(k)

Active United States

510(k) K972259

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972259 Date10 Jul 1997ClearedStatusActive

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  • Withdrawn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, 19 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 Pro Check Digital Pacifier Thermometer is a continuous measurement thermometer (product code FLL) designed for oral temperature assessment in infants and children up to five years of age. It combines a digital temperature sensor with a pacifier-style silicone nipple, providing a non-invasive method for accurate body temperature readings.

This reusable device features a battery-powered liquid crystal display (LCD) housed in an ABS plastic body, with the thermometer embedded within a medical-grade silicone nipple. Supplied sterile upon receipt, it is intended for single-use per patient to maintain hygiene standards. The device holds FDA 510(k) clearance (K972259) under traditional review and is classified as Class II under special controls.

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