510(k) · Cleared
ClearedDigital Thermomter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · FLL Continuous Measurement Thermometer
Cleared on Feb 5, 2013 as substantially equivalent to K091676 (Omron Healthcare, Inc., 2009) after a 172-day review. Its family tree reaches back 2 generations to 1988. 2 later devices descend from it.
- Decided
- Feb 5, 2013
- Review
- 172 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K881446 (1988). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK881446 Ormon Digital Fever Thermometer Model MC-3BOrmon Electronics, Inc. · 1988
- 1 generation backK091676 MC-245, MC-246, MC-247, MC-341, MC-343, MC-344Omron Healthcare, Inc. · 2009
- This deviceK122520 Digital ThermomterTaidoc Technology Corporation · 2013
- Descendant · cites it directly · 1 of its ownK133111 Kingtech Digital ThermometerKingtech Enterprise, Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK161211 Digital ThermometerBiocare Asia Corporation, Ltd. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881446 | Ormon Digital Fever Thermometer Model MC-3B | Ormon Electronics, Inc. | 1988 | — |
| −1 | K091676 | MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 | Omron Healthcare, Inc. | 2009 | — |
| 0 (this device) | K122520 | Digital Thermomter | Taidoc Technology Corporation | 2013 | — |
| +1 | K133111 | Kingtech Digital Thermometer | Kingtech Enterprise, Ltd. | 2013 | — |
| +2 | K161211 | Digital Thermometer | Biocare Asia Corporation, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K091676 | MC-245, MC-246, MC-247, MC-341, MC-343, MC-344Summary page 2…e thermistor contacts. Substantial Equivalence Information: A. Predicate device name: Omron electronic thermometer Models MC-246 B. Predicate K number: K091676 C. Comparison with predicate: The Digital Thermometer, model TD-lOOI1, has the following similarities to the predica… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133111 | Kingtech Digital Thermometer | 2013 | 1 |
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 3 companies; a new generation was cleared every 21.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K133111 (Kingtech Enterprise, Ltd., 2013) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K091676.
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?
TD-1001 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/K122520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122520: Digital Thermomter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122520
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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