510(k) · Cleared
ClearedDeRoyal Temperature Monitoring Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deroyal Industries, Inc. · FLL Continuous Measurement Thermometer
Cleared on Dec 23, 2020 as substantially equivalent to K925791 (Deroyal Industries, Inc., 1994) and 1 other predicate after a 288-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Dec 23, 2020
- Review
- 288 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K925791 (1994). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK925791 Exac-Temp & Clini-Temp Probe W/Temperature SensorDeroyal Industries, Inc. · 1994 · Recalled
- This deviceK200631 DeRoyal Temperature Monitoring ProbeDeroyal Industries, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK251160 Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A…Shenzhen Med-Link Electronics Tech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK212945 Sterile Disposable Temperature ProbeShenzhen Envisen Industry Co., Ltd. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925791 | Exac-Temp & Clini-Temp Probe W/Temperature Sensor | Deroyal Industries, Inc. | 1994 | 1 |
| 0 (this device) | K200631 | DeRoyal Temperature Monitoring Probe | Deroyal Industries, Inc. | 2020 | — |
| +1 | K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P… | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2026 | — |
| +1 | K212945 | Sterile Disposable Temperature Probe | Shenzhen Envisen Industry Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K925791 | Exac-Temp & Clini-Temp Probe W/Temperature SensorSummary page 4…cate Devices: Exac-Temp & Clini-Temp Probe w/ Temperature Sensor [K925791] – Primary Predicate Exa… | 1994 |
| * | K925792 | Exac-Temp & Clini-Temp Tympanic & Myocardial ProbeSummary page 4…Primary Predicate Exac-Temp & Clini-Temp Tympanic Probe [K925792] Page 1 C… | 1994 |
| † | K925006 | Hydro-Temp Nicu and Skin Surface Temperature Senso | 1994 |
| † | K101244 | Skin Sensor Probe, General Purpose Probe, Tympanic Probe | 2010 |
| † | K140134 | Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope… | 2014 |
| † | K181967 | Disposable Temperature Probe | 2018 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The DeRoyal Temperature Monitoring Probe is used for routine monitoring of the patient's core body or skin surface temperature. The probe is offered in the following three configurations: - General Purpose Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion into the nasopharyngeal, esophageal, or rectal cavities. - Adult Skin Temperature Sensor for routine monitoring of skin temperature by…
Read the full statement (156 words)
The DeRoyal Temperature Monitoring Probe is used for routine monitoring of the patient's core body or skin surface temperature.
The probe is offered in the following three configurations:
- General Purpose Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion into the nasopharyngeal, esophageal, or rectal cavities.
- Adult Skin Temperature Sensor for routine monitoring of skin temperature by application of the probe's adhesive cover to an adult patient's skin surface.
- Tympanic Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion of the ear piece into the aural canal.
The device is single use and for use by licensed healthcare practitioners only. The probes are designed to interface with DeRoyal-branded cables for connection with YSI 400 or 700 series compatible monitors, including the following patient monitors and equivalent models: Mindray Passport, Philips IntelliVue, Siemens/Draeger Infinity, and GE Datex-Ohmeda brands.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200631 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200631: DeRoyal Temperature Monitoring Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200631
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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