510(k) Report

510(k) · Cleared

Cleared

Rii Infrared Ear Thermometer, Models TH5XY Series

K063185510(k) SpecialCleared Nov 17, 200628-day reviewClass II21 CFR 880.2910

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

Radiant Innovation, Inc. · FLL Continuous Measurement Thermometer

Cleared on Nov 17, 2006 as substantially equivalent to K051269 (Radiant Innovation, Inc., 2005) after a 28-day review. Its family tree reaches back 4 generations to 2001. 18 later devices descend from it.

Decided
Nov 17, 2006
Review
28 days
Class
Class II
Product code
FLL
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K011059 (2001). 18 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2010: 2 descendants cleared2017: 1 descendant cleared2018: 2 descendants cleared2019: 2 descendants cleared2022: 3 descendants cleared2020: 2 descendants cleared2021: 3 descendants cleared2023: 1 descendant cleared2025: 1 descendant clearedK011059 · Infared Ear Thermometer, Model TH8 Series · Radiant Innovation, Inc. · 2001K030324 · Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 Series · Radiant Innovation, Inc. · 2003K040377 · Rii Infrared Ear Thermometer, Models Thxxn Series · Radiant Innovation, Inc. · 2004K051269 · Rii Infrared Ear Thermometer, Models TH00XY Series · Radiant Innovation, Inc. · 2005200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 7 descendants4 generations forward: 4 descendants K051269 · Rii Infrared Ear Thermometer, Models TH00XY Series · Radiant Innovation, Inc. · 2005K040377 · Rii Infrared Ear Thermometer, Models Thxxn Series · Radiant Innovation, Inc. · 2004K030324 · Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 Series · Radiant Innovation, Inc. · 2003K011059 · Infared Ear Thermometer, Model TH8 Series · Radiant Innovation, Inc. · 20010
  1. Root · 4 generations backK011059 Infared Ear Thermometer, Model TH8 SeriesRadiant Innovation, Inc. · 2001
  2. 3 generations backK030324 Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 SeriesRadiant Innovation, Inc. · 2003
  3. 2 generations backK040377 Rii Infrared Ear Thermometer, Models Thxxn SeriesRadiant Innovation, Inc. · 2004
  4. 1 generation backK051269 Rii Infrared Ear Thermometer, Models TH00XY SeriesRadiant Innovation, Inc. · 2005
  5. This deviceK063185 Rii Infrared Ear Thermometer, Models TH5XY SeriesRadiant Innovation, Inc. · 2006
  6. Descendant · cites it directly · 14 of its ownK162083 RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc. · 2017
  7. Descendant · 2 generations on · 8 of its ownK191570 Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd. · 2019
  8. Descendant · 2 generations on · 3 of its ownK181239 Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd. · 2018
  9. Descendant · 3 generations on · 2 of its ownK190873 Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd. · 2019
  10. Descendant · 3 generations on · 1 of its ownK213011 Infrared Thermometer (model: E201)Bioland Technology, Ltd. · 2022

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2007: 12010: 22017: 12018: 22019: 22020: 22021: 32022: 32023: 12025: 1
2007high 3 (2021) · low 0 (2008)2026

Most influential descendants

Showing 5 of 18 · See all
  • K162083RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc. · 2017 · cites it directly14descendants
  • K191570Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd. · 2019 · 2 generations on8descendants
  • K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd. · 2018 · 2 generations on3descendants
  • K190873Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd. · 2019 · 3 generations on2descendants
  • K213011Infrared Thermometer (model: E201)Bioland Technology, Ltd. · 2022 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K011059Infared Ear Thermometer, Model TH8 SeriesRadiant Innovation, Inc.2001—
−3K030324Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 SeriesRadiant Innovation, Inc.2003—
−2K040377Rii Infrared Ear Thermometer, Models Thxxn SeriesRadiant Innovation, Inc.2004—
−1K051269Rii Infrared Ear Thermometer, Models TH00XY SeriesRadiant Innovation, Inc.2005—
0 (this device)K063185Rii Infrared Ear Thermometer, Models TH5XY SeriesRadiant Innovation, Inc.2006—
+1K162083RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc.2017—
+2K191570Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd.2019—
+2K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd.2018—
+3K190873Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd.2019—
+3K213011Infrared Thermometer (model: E201)Bioland Technology, Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201020
201710
201820
201920
202020
202130
202230
202310
202510
FIG. 1 — Lineage of K063185, 2001–2025Source: 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 FLL? 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 FLL device

  1. #1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 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? (1)

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
*K051269Rii Infrared Ear Thermometer, Models TH00XY Series
Summary page 1
…TH5XY series (TH-500/50Z, TH520 and TH560/56Z) 3. Current Clearance Device: Radiant Innovation Infrared Ear Thermometer, Models THOOXY series (FDA#: K051269), THXXN series (FDA#: K040377), THI series (FDA#: K030324), TH88 series (FDA#: K020504) and TH8 series (FDA…
Radiant Innovation, Inc.2005—

What descends from it? (18)

See all 18

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162083RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc.201714
K070976Rii Infrared Ear Thermometer, Model TH01BNRadiant Innovation, Inc.20071
K102187Rii Infrared Ear Thermometer,Radiant Innovation, Inc.20100

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?

  • The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K162083 (Radiant Innovation, Inc., 2017) has gone furthest, with 14 descendants of its own.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLL

6in 2025

2007: 152008: 142009: 132010: 242011: 202012: 172013: 142014: 72015: 32016: 222017: 162018: 352019: 222020: 212021: 432022: 242023: 172024: 132025: 62026 (partial year): 2
2007high 43 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLL

131in 2025

2007: 81 days median2008: 59 days median2009: 84 days median2010: 88 days median2011: 113 days median2012: 126 days median2013: 149 days median2014: 199 days median2015: 270 days median2016: 157 days median2017: 174 days median2018: 209 days median2019: 198 days median2020: 194 days median2021: 218 days median2022: 218 days median2023: 295 days median2024: 223 days median2025: 131 days median
2007high 295 (2023) · low 59 (2008)2026

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

Recalls per year · FLL

1in 2025

2011: 12015: 12017: 22018: 12019: 52025: 12026 (partial year): 1
2007high 5 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FLL

73in 2025

2007: 42008: 132009: 92010: 92011: 182012: 262013: 162014: 542015: 532016: 582017: 1182018: 512019: 522020: 532021: 1152022: 1422023: 1012024: 1182025: 73
2007high 142 (2022) · low 4 (2007)2025

MAUDE reports naming product code FLL, 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
2007158104
20081459013
2009138409
2010248809
201120113118
201217126026
201314149016
20147199054
20153270153
201622157058
2017161742118
201835209151
201922198552
202021194053
2021432180115
2022242180142
2023172950101
2024132230118
20256131173
20262—1—

What is it indicated for?

The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

Indications for use as stated in the FDA summary.

More from Radiant Innovation, Inc.

15 FDA decisions under this applicant name. See the company

  • K240648Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)Radiant Innovation, Inc. · 2024
  • K163601RII Smart IR ThermometerRadiant Innovation, Inc. · 2018
  • K162083RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc. · 2017
  • K121428Non-Contact Clinical ThermometerRadiant Innovation, Inc. · 2012
  • K111637Infrared Ear ThermometerRadiant Innovation, Inc. · 2011

Recent decisions in FLL

The FLL category page

  • K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature…Unimed Medical Supplies, Inc. · 2026
  • K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd. · 2026
  • K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd. · 2025
  • K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd. · 2025
  • K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · 2025

https://510kreport.com/device/K063185 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063185: Rii Infrared Ear Thermometer, Models TH5XY Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063185

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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