510(k) Report

510(k) · Cleared

Cleared

Kejump Digital Clinical Thermometer

K903590510(k) TraditionalCleared Oct 22, 199075-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

K-Jump Health Co., Ltd. · FLL Continuous Measurement Thermometer

Cleared on Oct 22, 1990 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Oct 22, 1990
Review
75 days
Class
Class II
Product code
FLL
Recalls
None
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared1996: 1 descendant cleared2004: 1 descendant cleared1990200020102020
  1. This deviceK903590 Kejump Digital Clinical ThermometerK-Jump Health Co., Ltd. · 1990
  2. Descendant · cites it directly · 1 of its ownK023711 Digital Thermometer Classic Type and Flexible TypeAcute Ideas Co., Ltd. · 2002
  3. Descendant · 2 generations on · 0 of its ownK032434 Clinical Electronic ThermometerCotronic Manufacturing · 2004
  4. Descendant · cites it directly · 0 of its ownK021851 Digital Clinical Thermometer, Model KD-193K-Jump Health Co., Ltd. · 2002
  5. Descendant · cites it directly · 0 of its ownK962369 Talking Digital ThermometerUltmost Industrial Corp. · 1996

Most influential descendants

Showing 4 of 4 · See all
  • K023711Digital Thermometer Classic Type and Flexible TypeAcute Ideas Co., Ltd. · 2002 · cites it directly1descendant
  • K032434Clinical Electronic ThermometerCotronic Manufacturing · 2004 · 2 generations on0descendants
  • K021851Digital Clinical Thermometer, Model KD-193K-Jump Health Co., Ltd. · 2002 · cites it directly0descendants
  • K962369Talking Digital ThermometerUltmost Industrial Corp. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K903590Kejump Digital Clinical ThermometerK-Jump Health Co., Ltd.1990—
+1K023711Digital Thermometer Classic Type and Flexible TypeAcute Ideas Co., Ltd.2002—
+2K032434Clinical Electronic ThermometerCotronic Manufacturing2004—
+1K021851Digital Clinical Thermometer, Model KD-193K-Jump Health Co., Ltd.2002—
+1K962369Talking Digital ThermometerUltmost Industrial Corp.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200220
200410
FIG. 1 — Lineage of K903590, 1990–2004Source: 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K023711Digital Thermometer Classic Type and Flexible TypeAcute Ideas Co., Ltd.20021
K021851Digital Clinical Thermometer, Model KD-193K-Jump Health Co., Ltd.20020
K962369Talking Digital ThermometerUltmost Industrial Corp.19960

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, K023711 (Acute Ideas Co., Ltd., 2002) has gone furthest, with 1 descendant 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—
Cite this page

510(k) Report. “K903590: Kejump Digital Clinical Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K903590

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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