510(k) Report

510(k) · Cleared

Cleared

Funet Amy Mama Body Thermometer

K003326510(k) TraditionalCleared Apr 11, 2001169-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

Funai Radio & Communications Corp. · FLL Continuous Measurement Thermometer

Cleared on Apr 11, 2001 after a 169-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 57 later devices descend from it.

Decided
Apr 11, 2001
Review
169 days
Class
Class II
Product code
FLL
Recalls
None
Predicates
0

57 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2003: 1 descendant cleared2009: 1 descendant cleared2004: 1 descendant cleared2006: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2023: 7 descendants cleared2015: 2 descendants cleared2010: 1 descendant cleared2014: 2 descendants cleared2016: 4 descendants cleared2012: 1 descendant cleared2020: 3 descendants cleared2017: 1 descendant cleared2019: 2 descendants cleared2018: 2 descendants cleared2024: 8 descendants cleared2021: 5 descendants cleared2022: 3 descendants cleared2025: 6 descendants cleared2026: 2 descendants cleared200020052010201520202025
  1. This deviceK003326 Funet Amy Mama Body ThermometerFunai Radio & Communications Corp. · 2001
  2. Descendant · cites it directly · 39 of its ownK062445 Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd. · 2007
  3. Descendant · 2 generations on · 38 of its ownK081256 Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HRio Flexon Technology Co., Ltd. · 2008
  4. Descendant · 3 generations on · 37 of its ownK100226 Wireless Body Temperature Monitor Model BTM-Dix Series…Rio Flexon Technology Co., Ltd. · 2010
  5. Descendant · 4 generations on · 36 of its ownK121696 Wireless ThermometerRaling Medical Company · 2012
  6. Descendant · 5 generations on · 35 of its ownK132761 Wireless ThermometerRaiing Medical Company · 2014

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12006: 12007: 22008: 12009: 12010: 12011: 12012: 12014: 22015: 22016: 42017: 12018: 22019: 22020: 32021: 52022: 32023: 72024: 82025: 62026: 2
2003high 8 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 57 · See all
  • K062445Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd. · 2007 · cites it directly39descendants
  • K081256Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HRio Flexon Technology Co., Ltd. · 2008 · 2 generations on38descendants
  • K100226Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H)Rio Flexon Technology Co., Ltd. · 2010 · 3 generations on37descendants
  • K121696Wireless ThermometerRaling Medical Company · 2012 · 4 generations on36descendants
  • K132761Wireless ThermometerRaiing Medical Company · 2014 · 5 generations on35descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003326Funet Amy Mama Body ThermometerFunai Radio & Communications Corp.2001—
+1K062445Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd.2007—
+2K081256Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HRio Flexon Technology Co., Ltd.2008—
+3K100226Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H)Rio Flexon Technology Co., Ltd.2010—
+4K121696Wireless ThermometerRaling Medical Company2012—
+5K132761Wireless ThermometerRaiing Medical Company2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200610
200720
200810
200910
201010
201110
201210
201420
201520
201640
201710
201820
201920
202030
202150
202230
202370
202480
202560
202620
FIG. 1 — Lineage of K003326, 2001–2026Source: 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), 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?

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

What descends from it? (57)

See all 57

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

NumberDeviceApplicantDecidedDescendants
K062445Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd.200739
K023956Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/FMesure Technology Co., Ltd.200434
K083185Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG System, Model S1Cadi Scientific Pte.Ltd20096
K060240K-Jump Digital Thermometer with Battery-Less Patch, Model KD-2100K-Jump Health Co., Ltd.20060
K030219Digital Temperature Monitor; Model KY-01Kang Ying Medical Appliances, Inc.20030

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, K062445 (Rio Flexon Technology Co., Ltd., 2007) has gone furthest, with 39 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—

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/K003326 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003326: Funet Amy Mama Body Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003326

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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