510(k) Report

510(k) · Cleared

Cleared

Rpi Skin or Air Temperature Probe

K020219510(k) TraditionalCleared Apr 12, 200280-day reviewClass II21 CFR 880.5130

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Replacement Parts Industries, Inc. · FMT Warmer, Infant Radiant

Cleared on Apr 12, 2002 as substantially equivalent to K970686 (Kentec Medical, Inc., 1997) and 2 other predicates after an 80-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided
Apr 12, 2002
Review
80 days
Class
Class II
Product code
FMT
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K950422 (1997). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1997: 1 other ancestor2008: 1 descendant clearedK950422 · First Touch Disposables Temperature Probes · First Touch Disposables, Inc. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K950422 · First Touch Disposables Temperature Probes · First Touch Disposables, Inc. · 19970
  1. Root · 1 generation backK950422 First Touch Disposables Temperature ProbesFirst Touch Disposables, Inc. · 1997
  2. This deviceK020219 Rpi Skin or Air Temperature ProbeReplacement Parts Industries, Inc. · 2002
  3. Descendant · cites it directly · 0 of its ownK071977 Tarry Medical Temperature ProbesTarry Medical Products, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K071977Tarry Medical Temperature ProbesTarry Medical Products, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K950422First Touch Disposables Temperature ProbesFirst Touch Disposables, Inc.1997—
0 (this device)K020219Rpi Skin or Air Temperature ProbeReplacement Parts Industries, Inc.2002—
+1K071977Tarry Medical Temperature ProbesTarry Medical Products, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K020219, 1997–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FMT device

  1. #1 K243606 Babyroo TN300score 9.3 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K970686Accutemp-Probe
Summary page 1
…tially equivalent in design and indications for use to the following devices currently in commercial distribution: e Accutemp-Probe, Kentec Medical, Inc., 510(k) number K970686 e Hill-Rom ISOLETTE Infant Incubator; Hill-Rom Air-Shields, Hatboro, PA 19040; 510(k) number K001242 ¢ First Touch Disposables…
Kentec Medical, Inc.1997—
*K001242Isolette Infant Incubator, Model C2HS
Summary page 1
…istribution: e Accutemp-Probe, Kentec Medical, Inc., 510(k) number K970686 e Hill-Rom ISOLETTE Infant Incubator; Hill-Rom Air-Shields, Hatboro, PA 19040; 510(k) number K001242 ¢ First Touch Disposables Temperature Probes, First Touch Disposables, Inc., Wilmington, NC 28403; 510(k) number K950422 IV. DE…
Hill-Rom Air-Shields2000—
*K950422First Touch Disposables Temperature Probes
Summary page 1
…m Air-Shields, Hatboro, PA 19040; 510(k) number K001242 ¢ First Touch Disposables Temperature Probes, First Touch Disposables, Inc., Wilmington, NC 28403; 510(k) number K950422 IV. DESCRIPTION The RPI Temperature Probes are intended to be used as replacement parts for Air Shields infant radiant warmers…
First Touch Disposables, Inc.1997—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071977Tarry Medical Temperature ProbesTarry Medical Products, Inc.20080

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K071977 (Tarry Medical Products, Inc., 2008) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FMT devices

FMT Warmer, Infant Radiant: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMT

1in 2025

2007: 22009: 12010: 12011: 12012: 42013: 12018: 12020: 22021: 12022: 12023: 12025: 1
2007high 4 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMT

103in 2012

2012: 103 days median
2007high 103 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMT

4in 2019

2008: 12009: 22013: 22014: 12015: 12016: 12018: 42019: 4, 4 Class I2026 (partial year): 2, 2 Class I
2007high 4 (2018) · low 0 (2007)2026

Class I (6 since 2007) Class II/III not classified

Adverse event reports per year · FMT

359in 2025

2007: 212008: 1142009: 802010: 1062011: 792012: 542013: 552014: 792015: 562016: 562017: 462018: 792019: 1,4372020: 1,6052021: 4732022: 1532023: 1752024: 2572025: 359
2007high 1,605 (2020) · low 21 (2007)2025

MAUDE reports naming product code FMT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—021
20080—1114
20091—280
20101—0106
20111—079
20124103054
20131—255
20140—179
20150—156
20160—156
20170—046
20181—479
20190—4 (4)1,437
20202—01,605
20211—0473
20221—0153
20231—0175
20240—0257
20251—0359
20260—2 (2)—

What is it indicated for?

RPI Skin or Air Temperature Probes are designed to be used as replacement temperature sensing probes for use with the temperature controller portion of Air Shields infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain pre-selected temperature settings.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Replacement Parts Industries, Inc.

3 FDA decisions under this applicant name. See the company

  • K020966Rpi Replacement Heating ElementsReplacement Parts Industries, Inc. · 2002
  • K021531Rpi Replacement Phototherapy LightsReplacement Parts Industries, Inc. · 2002

Recent decisions in FMT

The FMT category page

  • K243606Babyroo TN300Draeger Medical Systems, Inc. · 2025
  • K230278Babyroo TN300Draeger Medical Systems, Inc. · 2023
  • K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc. · 20222 Class I recalls
  • K201628Panda iRes Warmer, Giraffe WarmerGE Healthcare · 20211 Class I recall
  • K200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor…Deroyal Industries, Inc. · 2020

https://510kreport.com/device/K020219 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020219: Rpi Skin or Air Temperature Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020219

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026