510(k) · Cleared
ClearedTD-1035 Thermometer
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 Oct 22, 2018 as substantially equivalent to K152680 (Taidoc Technology Corporation, 2016) after a 406-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Oct 22, 2018
- Review
- 406 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K881446 (1988). No later device cites it as a predicate yet.
- 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 backK152680 TD-1035 ThermometerTaidoc Technology Corporation · 2016
- This deviceK172733 TD-1035 ThermometerTaidoc Technology Corporation · 2018
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 | K152680 | TD-1035 Thermometer | Taidoc Technology Corporation | 2016 | — |
| 0 (this device) | K172733 | TD-1035 Thermometer | Taidoc Technology Corporation | 2018 | — |
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 |
|---|---|---|---|
| * | K152680 | TD-1035 ThermometerSummary page 4…Device Class: Class II Regulation Number: 21 CFR §880.2910 3. Predicate Device Proprietary Name: TD-1035 Thermometer 510(K) no. K152680 4. Device Description TD-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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-1035 Thermometer is a temperature detector which is intended to measure the body temperature on axillary region.
The device is intended for population age of six months and above, which is designed for home use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172733 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172733: TD-1035 Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172733
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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