510(k) · Cleared
ClearedDigital Temperature Monitor, Model GT-202, GT-203, GT-204, and GT-205
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tenghi Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Oct 24, 2003 as substantially equivalent to K962520 (Mesure Technology, 1996) after a 25-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Oct 24, 2003
- Review
- 25 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962520 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK962520 Digital Clinical Thermometer ST-813A, ST-814A, ST-823 and ST-823AMesure Technology · 1996
- This deviceK033069 Digital Temperature Monitor, Model GT-202, GT-203, GT-204, and GT-205Tenghi Co., Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962520 | Digital Clinical Thermometer ST-813A, ST-814A, ST-823 and ST-823A | Mesure Technology | 1996 | — |
| 0 (this device) | K033069 | Digital Temperature Monitor, Model GT-202, GT-203, GT-204, and GT-205 | Tenghi Co., Ltd. | 2003 | — |
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 |
|---|---|---|---|
| * | K962520 | Digital Clinical Thermometer ST-813A, ST-814A, ST-823 and ST-823ASummary page 1…ure monito r, model GT-202/GT-203/GT-204/GT-205. 2. Information of the 51O(k) Cleared Device (Predicate Device): Digital clinical thermometer; model ST-813A (K962520). 3. Device Description: The Digital temperature monitor, model GT-202/GT-203/GT-204/GT-205, are the electronic… | 1996 |
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?
- Its one ancestor has no recall.
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 Digital temperature monitor, model GT-202, GT-203, GT-204, and GT-205 is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for the measurement of oral, armpit and rectal temperature of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033069 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033069: Digital Temperature Monitor, Model GT-202, GT-203, GT-204, and GT-205.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033069
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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