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RPI Skin or Air Temperature Probe

by Replacement Parts Industries, Inc.

510(k) K020219

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 NumberK020219 Date12 Apr 2002ClearedStatusActive

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  • Withdrawn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
FMT
Device Class
Class II
Regulation
21 CFR Part 880.5130
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

RPI Skin or Air Temperature Probe is a temperature sensing probe designed for use with the temperature controller portion of Air Shields infant radiant warmers and infant incubators. It provides skin or air temperature feedback to maintain thermal regulation in neonatal care settings.

The device is supplied as a replacement part for infant radiant warmers and incubators. It is intended for use in general hospital environments and is authorized under FDA 510(k) clearance K020219. The probe is reusable and non-sterile, with no MRI safety information provided in the data.

Other devices from Replacement Parts Industries, Inc.

Questions

AI-generated answers, 28 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 RPI Skin or Air Temperature Probe used for?

    The RPI Skin or Air Temperature Probe is designed to provide skin or air temperature feedback to the temperature controller portion of Air Shields infant radiant warmers and infant incubators, helping maintain thermal regulation in neonatal care settings.

  • Is the RPI Skin or Air Temperature Probe sterile or single-use?

    The probe is supplied as a non-sterile, reusable replacement part for infant radiant warmers and incubators, meaning it can be cleaned and used multiple times according to hospital protocols.

  • What regulatory authorization does the RPI Skin or Air Temperature Probe have?

    The device is authorized under FDA 510(k) clearance K020219, which was granted on April 12, 2002, after being found substantially equivalent to a legally marketed predicate device.