510(k) · Cleared
ClearedDigital Thermometer Classic Type and Flexible Type
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acute Ideas Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Nov 21, 2002 as substantially equivalent to K903590 (K-Jump Health Co., Ltd., 1990) and 1 other predicate after a 17-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- Nov 21, 2002
- Review
- 17 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K903590 (1990). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK903590 Kejump Digital Clinical ThermometerK-Jump Health Co., Ltd. · 1990
- This deviceK023711 Digital Thermometer Classic Type and Flexible TypeAcute Ideas Co., Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK032434 Clinical Electronic ThermometerCotronic Manufacturing · 2004
Most influential descendants
Showing 1 of 1 · See all- K032434Clinical Electronic ThermometerCotronic Manufacturing · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903590 | Kejump Digital Clinical Thermometer | K-Jump Health Co., Ltd. | 1990 | — |
| 0 (this device) | K023711 | Digital Thermometer Classic Type and Flexible Type | Acute Ideas Co., Ltd. | 2002 | — |
| +1 | K032434 | Clinical Electronic Thermometer | Cotronic Manufacturing | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
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 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K903590 | Kejump Digital Clinical ThermometerSummary page 1…, 2002 2. Name of the Device: Digital Thermometer Classic Type and Flexible Type 3. Predicate Device Information: 1) KEJUMP Digital Clinical Thermometer, K903590, K-Jump Health Co., Ltd. 2) Flexible Tip Digital Thermometer, K974195, K-Jump Health Co., Ltd. 4. Device Description: T… | 1990 |
| * | K974195 | Flexible Tip Digital ThermometerSummary page 1…Flexible Type 3. Predicate Device Information: 1) KEJUMP Digital Clinical Thermometer, K903590, K-Jump Health Co., Ltd. 2) Flexible Tip Digital Thermometer, K974195, K-Jump Health Co., Ltd. 4. Device Description: The Digital Thermometer is an electronic clinical thermometer intended for… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032434 | Clinical Electronic Thermometer | 2004 | 0 |
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?
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 2025
MAUDE reports naming product code FLL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 81 | 0 | 4 |
| 2008 | 14 | 59 | 0 | 13 |
| 2009 | 13 | 84 | 0 | 9 |
| 2010 | 24 | 88 | 0 | 9 |
| 2011 | 20 | 113 | 1 | 18 |
| 2012 | 17 | 126 | 0 | 26 |
| 2013 | 14 | 149 | 0 | 16 |
| 2014 | 7 | 199 | 0 | 54 |
| 2015 | 3 | 270 | 1 | 53 |
| 2016 | 22 | 157 | 0 | 58 |
| 2017 | 16 | 174 | 2 | 118 |
| 2018 | 35 | 209 | 1 | 51 |
| 2019 | 22 | 198 | 5 | 52 |
| 2020 | 21 | 194 | 0 | 53 |
| 2021 | 43 | 218 | 0 | 115 |
| 2022 | 24 | 218 | 0 | 142 |
| 2023 | 17 | 295 | 0 | 101 |
| 2024 | 13 | 223 | 0 | 118 |
| 2025 | 6 | 131 | 1 | 73 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Device measures the human body temperature from oral, axillary, and rectal. The device is reusable and intended for clinical or home use on people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023711 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023711: Digital Thermometer Classic Type and Flexible Type.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023711
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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