510(k) Report

510(k) · Cleared

Cleared

First Touch Disposables Temperature Probes

K950422510(k) TraditionalCleared Jan 23, 1997721-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

First Touch Disposables, Inc. · FMT Warmer, Infant Radiant

Cleared on Jan 23, 1997 after a 721-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Jan 23, 1997
Review
721 days
Class
Class II
Product code
FMT
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2008: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950422 First Touch Disposables Temperature ProbesFirst Touch Disposables, Inc. · 1997
  2. Descendant · cites it directly · 1 of its ownK020219 Rpi Skin or Air Temperature ProbeReplacement Parts Industries, Inc. · 2002
  3. Descendant · 2 generations on · 0 of its ownK071977 Tarry Medical Temperature ProbesTarry Medical Products, Inc. · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K020219Rpi Skin or Air Temperature ProbeReplacement Parts Industries, Inc. · 2002 · cites it directly1descendant
  • K071977Tarry Medical Temperature ProbesTarry Medical Products, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950422First Touch Disposables Temperature ProbesFirst Touch Disposables, Inc.1997—
+1K020219Rpi Skin or Air Temperature ProbeReplacement Parts Industries, Inc.2002—
+2K071977Tarry Medical Temperature ProbesTarry Medical Products, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200810
FIG. 1 — Lineage of K950422, 1997–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K020219Rpi Skin or Air Temperature ProbeReplacement Parts Industries, Inc.20021

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?

  • Of its descendants, K020219 (Replacement Parts Industries, Inc., 2002) has gone furthest, with 1 descendant 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)—

More from First Touch Disposables, Inc.

2 FDA decisions under this applicant name. See the company

  • K915752First Touch/Viledon Non-Woven FilterFirst Touch Disposables, Inc. · 1992

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/K950422 · printed Nov 5, 2026

Cite this page

510(k) Report. “K950422: First Touch Disposables Temperature Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K950422

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026