510(k) · Cleared
ClearedAgeless Health Medical Digital Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dongguan Ageless Health Industrial Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Dec 31, 2015 as substantially equivalent to K131210 (Shenzhen Pump Medical System Co., Ltd., 2014) after a 120-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Dec 31, 2015
- Review
- 120 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902624 (1990). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK902624 BD Flexible Digital ThermometerBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 2 generations backK062784 Sejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403…Sejoy Electronics & Instruments Co., Ltd. · 2007
- 1 generation backK131210 Electronic ThermometerShenzhen Pump Medical System Co., Ltd. · 2014
- This deviceK152508 Ageless Health Medical Digital ThermometerDongguan Ageless Health Industrial Co., Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902624 | BD Flexible Digital Thermometer | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −2 | K062784 | Sejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403 and MT-405) | Sejoy Electronics & Instruments Co., Ltd. | 2007 | — |
| −1 | K131210 | Electronic Thermometer | Shenzhen Pump Medical System Co., Ltd. | 2014 | — |
| 0 (this device) | K152508 | Ageless Health Medical Digital Thermometer | Dongguan Ageless Health Industrial Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K131210 | Electronic ThermometerSummary page 5…HENZHEN PUMP MEDICAL SYSTEM CO., LTD. Classification Name: Thermometer, electronic, clinical Trade Name: Electronic thermometer 510(k) number: K131210 Review Panel: General Hospital Product Code: FLL Regulation Number: 880.2910 Regulation Class:… | 2014 |
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 25 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- None of the 5 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. 2015, 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?
Ageless Health Medical Digital Thermometers are intended for use in measuring human body temperature (Armpit or Oral).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152508: Ageless Health Medical 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/K152508
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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