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Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618

by Shenzhen Pango Medical Electronics Co., Ltd

510(k) K212346

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 NumberK212346 Date5 May 2022ClearedStatusActive

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  • Withdrawn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
Shenzhen Pango Medical Electronics Co., Ltd.
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

An infrared thermometer is a medical device used to measure human body temperature by detecting infrared energy emitted from the skin. This device is designed for non-contact temperature measurement and is available in multiple models for forehead or ear canal measurement.

The device can be used on people of all ages in home or hospital environments. It is supplied as a reusable device and received FDA 510(k) clearance under K number K212346 on May 5, 2022. No information regarding sterility, single-use status, MRI safety, sizes, or storage conditions is provided in the data.

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Questions

AI-generated answers, 1 Oct 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 Infrared Thermometer PG-IRT1612/PG-IRT1613/PG-IRT1615/PG-IRT1618 used for?

    This device measures human body temperature by detecting infrared energy emitted from the skin, designed for non-contact temperature measurement on the forehead or ear canal. It can be used on people of all ages in home or hospital environments, providing a hygienic alternative to contact thermometers.

  • Is the Infrared Thermometer PG-IRT1612/PG-IRT1613/PG-IRT1615/PG-IRT1618 sterile or single-use?

    The device is supplied as a reusable device, meaning it is intended for multiple uses after appropriate cleaning between patients. No sterility information is provided in the data, so it is not marketed as sterile and should be cleaned according to manufacturer guidelines before each use.

  • What regulatory clearance does the Infrared Thermometer PG-IRT1612/PG-IRT1613/PG-IRT1615/PG-IRT1618 have?

    The device received FDA 510(k) clearance under K number K212346 on May 5, 2022, indicating it was found substantially equivalent to a legally marketed predicate device. This clearance allows it to be legally marketed in the United States for its intended use.