510(k) · Cleared
Recalled · 2005UP-Grade and UP-Grade Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisim, Ltd. · FLL Continuous Measurement Thermometer
Cleared on Feb 12, 1999 as substantially equivalent to K964643 (Diatek Instruments, Inc., 1997) and 1 other predicate after a 102-day review. Its family tree reaches back 1 generation to 1990. 6 later devices descend from it. It has been recalled once.
- Decided
- Feb 12, 1999
- Review
- 102 days
- Class
- Class II
- Product code
- FLL
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902624 (1990). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK902624 BD Flexible Digital ThermometerBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- This deviceK983887 UP-Grade and UP-Grade ProMedisim, Ltd. · 1999
- Descendant · cites it directly · 5 of its ownK032362 UP-Grade Forehead ThermometerMedisim, Ltd. · 2003
- Descendant · 2 generations on · 1 of its ownK103839 Behind Ear Gentle Touch ThermometerKaz, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK070491 Digital Forehead Thermometer, Model# KD-2200K-Jump Health Co., Ltd. · 2007
- Descendant · 2 generations on · 1 of its ownK051422 Dual Mode UP-Grade Forehead/Underarm Thermometer DeviceMedisim, Ltd. · 2005
- Descendant · 3 generations on · 0 of its ownK131155 UGFT3; FHT7Medisim, Ltd. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K032362UP-Grade Forehead ThermometerMedisim, Ltd. · 2003 · cites it directly5descendants
- K103839Behind Ear Gentle Touch ThermometerKaz, Inc. · 2011 · 2 generations on1descendant
- K070491Digital Forehead Thermometer, Model# KD-2200K-Jump Health Co., Ltd. · 2007 · 2 generations on1descendant
- K051422Dual Mode UP-Grade Forehead/Underarm Thermometer DeviceMedisim, Ltd. · 2005 · 2 generations on1descendant
- K131155UGFT3; FHT7Medisim, Ltd. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902624 | BD Flexible Digital Thermometer | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| 0 (this device) | K983887 | UP-Grade and UP-Grade Pro | Medisim, Ltd. | 1999 | — |
| +1 | K032362 | UP-Grade Forehead Thermometer | Medisim, Ltd. | 2003 | — |
| +2 | K103839 | Behind Ear Gentle Touch Thermometer | Kaz, Inc. | 2011 | — |
| +2 | K070491 | Digital Forehead Thermometer, Model# KD-2200 | K-Jump Health Co., Ltd. | 2007 | — |
| +2 | K051422 | Dual Mode UP-Grade Forehead/Underarm Thermometer Device | Medisim, Ltd. | 2005 | — |
| +3 | K131155 | UGFT3; FHT7 | Medisim, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K964643 | SuretempSummary page 2…llary body temperature determination in humans. Predicate Device: The Up-Grade is substantially equivalent to Diatek Instruments, Inc.’s SureTemp™ Thermometer System, (K964643) and Becton Dickinson and Company’s B-D Flexible Thermometer (K902624). Device Description: The Up-Grade is a compact predictiv… | 1997 |
| * | K902624 | BD Flexible Digital ThermometerSummary page 2…e Up-Grade is substantially equivalent to Diatek Instruments, Inc.’s SureTemp™ Thermometer System, (K964643) and Becton Dickinson and Company’s B-D Flexible Thermometer (K902624). Device Description: The Up-Grade is a compact predictive clinical thermometer designed to measure human body temperature by d… | 1990 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032362 | UP-Grade Forehead Thermometer | 2003 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 25, 2005 | Not classified | Z-0466-06 | Other | Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
The Up-Grade is an over-the-counter, non-sterile, reusable clinical thermometer intended for the determination of oral, rectal, and axillary body temperature determination in humans.
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/K983887 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983887: UP-Grade and UP-Grade Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983887
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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