510(k) · Cleared
ClearedElectronic Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wiltec Industries, Ltd. · FLL Continuous Measurement Thermometer
Cleared on Jun 10, 1996 after a 26-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jun 10, 1996
- Review
- 26 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK961879 Electronic ThermometerWiltec Industries, Ltd. · 1996
- Descendant · cites it directly · 6 of its ownK021052 Model GT010706 Electronic ThermometerGlobal Treasure Industries, Ltd. · 2002
- Descendant · 2 generations on · 1 of its ownK062016 Rapid Digital Thermometer, Model RDT -18 SeriesChoice Smart Health Care Co., Ltd. · 2006
- Descendant · 3 generations on · 0 of its ownK072635 Clinical Electronic Thermometers, Model (S) MT901, MT518, Ect-1Ningbo Huahui Medical Instruments Co., Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK062010 Rapid Digital Thermometer, Model RDT -18 SeriesGlobal Treasure Industries, Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK030673 Flexible Tip Thermometer, Model 011206Global Treasure Industries, Ltd. · 2003
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K021052Model GT010706 Electronic ThermometerGlobal Treasure Industries, Ltd. · 2002 · cites it directly6descendants
- K062016Rapid Digital Thermometer, Model RDT -18 SeriesChoice Smart Health Care Co., Ltd. · 2006 · 2 generations on1descendant
- K072635Clinical Electronic Thermometers, Model (S) MT901, MT518, Ect-1Ningbo Huahui Medical Instruments Co., Ltd. · 2008 · 3 generations on0descendants
- K062010Rapid Digital Thermometer, Model RDT -18 SeriesGlobal Treasure Industries, Ltd. · 2006 · 2 generations on0descendants
- K030673Flexible Tip Thermometer, Model 011206Global Treasure Industries, Ltd. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961879 | Electronic Thermometer | Wiltec Industries, Ltd. | 1996 | — |
| +1 | K021052 | Model GT010706 Electronic Thermometer | Global Treasure Industries, Ltd. | 2002 | — |
| +2 | K062016 | Rapid Digital Thermometer, Model RDT -18 Series | Choice Smart Health Care Co., Ltd. | 2006 | — |
| +3 | K072635 | Clinical Electronic Thermometers, Model (S) MT901, MT518, Ect-1 | Ningbo Huahui Medical Instruments Co., Ltd. | 2008 | — |
| +2 | K062010 | Rapid Digital Thermometer, Model RDT -18 Series | Global Treasure Industries, Ltd. | 2006 | — |
| +2 | K030673 | Flexible Tip Thermometer, Model 011206 | Global Treasure Industries, Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K021052 (Global Treasure Industries, Ltd., 2002) has gone furthest, with 6 descendants of its own.
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 | — |
https://510kreport.com/device/K961879 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961879: Electronic Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961879
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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