510(k) · Cleared
Cleared9 Second Digital Thermometer, Model BT-S09
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metatech Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Dec 3, 2003 as substantially equivalent to K031958 (Microlife Intellectual Property GmbH, 2003) after a 65-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Dec 3, 2003
- Review
- 65 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943695 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK943695 SuretempAdvanced Bioresearch Assoc. · 1995
- 3 generations backK990168 Microlife IT2CA1Microlife Systems AG · 1999
- 2 generations backK012136 Avita Agil IT 101 Instant Digital ThermometerAvita Corporation · 2001
- 1 generation backK031958 Microlife Instant Digital Electronic Thermometer, Model QT1JA1Microlife Intellectual Property GmbH · 2003
- This deviceK033082 9 Second Digital Thermometer, Model BT-S09Metatech Co., Ltd. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943695 | Suretemp | Advanced Bioresearch Assoc. | 1995 | — |
| −3 | K990168 | Microlife IT2CA1 | Microlife Systems AG | 1999 | — |
| −2 | K012136 | Avita Agil IT 101 Instant Digital Thermometer | Avita Corporation | 2001 | — |
| −1 | K031958 | Microlife Instant Digital Electronic Thermometer, Model QT1JA1 | Microlife Intellectual Property GmbH | 2003 | — |
| 0 (this device) | K033082 | 9 Second Digital Thermometer, Model BT-S09 | Metatech 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 |
|---|---|---|---|
| * | K031958 | Microlife Instant Digital Electronic Thermometer, Model QT1JA1Summary page 1…Class: II Panel: 80 (General Hospital) Predicate Devices: Microlife MT3001 (QT1JA) K 031958 Page -2- (5 10k Summary) Device Description: The 9 second Digital Thermometer is designed to… | 2003 |
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 8 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K031958.
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?
This device is an electronic clinical thermometer using a thermistor probe sensor to detect body temperature. The device is measuring oral, rectal or axillary temperatures. It is intended for home use on people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033082 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033082: 9 Second Digital Thermometer, Model BT-S09.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033082
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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