510(k) · Cleared
ClearedDigital Thermometer; Digital Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Regulatory Consultants, LLC (Irc) · FLL Continuous Measurement Thermometer
Cleared on Dec 13, 2010 as substantially equivalent to K101043 (Changshan Estar Electronics Co., Ltd., 2010) after an 83-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Dec 13, 2010
- Review
- 83 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K881446 (1988). 4 ancestors in all. 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 backK101043 Ect Digital ThermometerChangshan Estar Electronics Co., Ltd. · 2010
- This deviceK102718 Digital Thermometer; Digital ThermometerInternational Regulatory Consultants, LLC (Irc) · 2010
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 | K101043 | Ect Digital Thermometer | Changshan Estar Electronics Co., Ltd. | 2010 | — |
| 0 (this device) | K102718 | Digital Thermometer; Digital Thermometer | International Regulatory Consultants, LLC (Irc) | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K101043 | Ect Digital ThermometerSummary page 1…meter . Medical spectalty (Panel): General Hospital Regulation number: 880.2910 Product Code: FLL Classification: Class II Predicate devices ECT Digital Thermometer(K101043)/Changshan Estar Electronics Co., Ltd. Indication for Use . GF-MT501 and GF-MTS02 digital thermometer are electronic clinical th… | 2010 |
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 22 years and passes through 4 companies; a new generation was cleared every 11 months 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. 2010, 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?
To measure the human body temperature in regular mode orally, rectally or underarm. The devices are reusable for clinical or home use on people of all ages.
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/K102718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102718: Digital Thermometer; 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/K102718
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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