510(k) · Cleared
ClearedKingtech Digital Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kingtech Enterprise, Ltd. · FLL Continuous Measurement Thermometer
Cleared on Dec 26, 2013 as substantially equivalent to K122520 (Taidoc Technology Corporation, 2013) after an 87-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.
- Decided
- Dec 26, 2013
- Review
- 87 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K881446 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK881446 Ormon Digital Fever Thermometer Model MC-3BOrmon Electronics, Inc. · 1988
- 2 generations backK091676 MC-245, MC-246, MC-247, MC-341, MC-343, MC-344Omron Healthcare, Inc. · 2009
- 1 generation backK122520 Digital ThermomterTaidoc Technology Corporation · 2013
- This deviceK133111 Kingtech Digital ThermometerKingtech Enterprise, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK161211 Digital ThermometerBiocare Asia Corporation, Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K161211Digital ThermometerBiocare Asia Corporation, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881446 | Ormon Digital Fever Thermometer Model MC-3B | Ormon Electronics, Inc. | 1988 | — |
| −2 | K091676 | MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 | Omron Healthcare, Inc. | 2009 | — |
| −1 | K122520 | Digital Thermomter | Taidoc Technology Corporation | 2013 | — |
| 0 (this device) | K133111 | Kingtech Digital Thermometer | Kingtech Enterprise, Ltd. | 2013 | — |
| +1 | K161211 | Digital Thermometer | Biocare Asia Corporation, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122520 | Digital ThermomterSummary page 1…l and hospital environments and consumers in a home environment. It is intended for use on people of all ages. Predicated K 122520, TaiDoc Digital Thermometer, TD-1001 Devices: TaiDoc Technology Corporation Device Description: Th… | 2013 |
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 |
|---|---|---|---|
| K161211 | Digital Thermometer | 2016 | 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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K161211 (Biocare Asia Corporation, Ltd., 2016) has gone furthest, with 0 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. 2013, this device’s year, is highlighted.
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?
TT1001 Digital Thermometer is intended to measure the body temperature orally and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133111: Kingtech Digital Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133111
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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