510(k) · Cleared
ClearedDigital Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocare Asia Corporation, Ltd. · FLL Continuous Measurement Thermometer
Cleared on Aug 29, 2016 as substantially equivalent to K133111 (Kingtech Enterprise, Ltd., 2013) after a 123-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Aug 29, 2016
- Review
- 123 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K881446 (1988). No later device cites it as a predicate yet.
- Root · 4 generations backK881446 Ormon Digital Fever Thermometer Model MC-3BOrmon Electronics, Inc. · 1988
- 3 generations backK091676 MC-245, MC-246, MC-247, MC-341, MC-343, MC-344Omron Healthcare, Inc. · 2009
- 2 generations backK122520 Digital ThermomterTaidoc Technology Corporation · 2013
- 1 generation backK133111 Kingtech Digital ThermometerKingtech Enterprise, Ltd. · 2013
- This deviceK161211 Digital ThermometerBiocare Asia Corporation, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881446 | Ormon Digital Fever Thermometer Model MC-3B | Ormon Electronics, Inc. | 1988 | — |
| −3 | K091676 | MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 | Omron Healthcare, Inc. | 2009 | — |
| −2 | K122520 | Digital Thermomter | Taidoc Technology Corporation | 2013 | — |
| −1 | K133111 | Kingtech Digital Thermometer | Kingtech Enterprise, Ltd. | 2013 | — |
| 0 (this device) | K161211 | Digital Thermometer | Biocare Asia Corporation, Ltd. | 2016 | — |
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 |
|---|---|---|---|
| * | K133111 | Kingtech Digital ThermometerSummary page 4…sa.hinet.net Predicate Device Kingtech Enterprises Limited KINGTECH Digital Thermometer, TT1001 K133111 Reference Device Omron Healthcare, Inc. Clinical Electronic Thermometer, MC-246… | 2013 |
| † | K091676 | MC-245, MC-246, MC-247, MC-341, MC-343, MC-344 | 2009 |
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 28 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 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. 2016, 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?
Digital Thermometer is intended to measure body temperature in axillary, oral or rectum and to be used by medical professionals in clinical and hospital environments or 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/K161211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161211: 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/K161211
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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