510(k) · Cleared
ClearedRapid Digital Thermometer, Model RDT -18 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choice Smart Health Care Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Oct 27, 2006 as substantially equivalent to K021052 (Global Treasure Industries, Ltd., 2002) after a 102-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Oct 27, 2006
- Review
- 102 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961879 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK961879 Electronic ThermometerWiltec Industries, Ltd. · 1996
- 1 generation backK021052 Model GT010706 Electronic ThermometerGlobal Treasure Industries, Ltd. · 2002
- This deviceK062016 Rapid Digital Thermometer, Model RDT -18 SeriesChoice Smart Health Care Co., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK072635 Clinical Electronic Thermometers, Model (S) MT901, MT518, Ect-1Ningbo Huahui Medical Instruments Co., Ltd. · 2008
Most influential descendants
Showing 1 of 1 · See all- K072635Clinical Electronic Thermometers, Model (S) MT901, MT518, Ect-1Ningbo Huahui Medical Instruments Co., Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961879 | Electronic Thermometer | Wiltec Industries, Ltd. | 1996 | — |
| −1 | K021052 | Model GT010706 Electronic Thermometer | Global Treasure Industries, Ltd. | 2002 | — |
| 0 (this device) | K062016 | Rapid Digital Thermometer, Model RDT -18 Series | Choice Smart Health Care Co., Ltd. | 2006 | — |
| +1 | K072635 | Clinical Electronic Thermometers, Model (S) MT901, MT518, Ect-1 | Ningbo Huahui Medical Instruments Co., Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K021052 | Model GT010706 Electronic ThermometerSummary page 1…X=0-9, Y=1-9) Classification Name: Thermometer, Electronic, Clinical 3. Predicate Device Information and Substantial Equivalence: Electronic Thermometer GTO10706 (K021052). 4. Device Description: The Rapid Digital Thermometer is an electronic thermometer by using a thermistor as the temperatu… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072635 | Clinical Electronic Thermometers, Model (S) MT901, MT518, Ect-1 | 2008 | 0 |
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 10 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K072635 (Ningbo Huahui Medical Instruments Co., Ltd., 2008) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K021052.
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?
It is an electronic thermometer used for clinical temperature measurement. It is intended
for use at home and hospital environment for both children and adult.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062016: Rapid Digital Thermometer, Model RDT -18 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062016
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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