510(k) · Cleared
ClearedSterile Disposable Temperature Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Envisen Industry Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Mar 1, 2022 as substantially equivalent to K200631 (Deroyal Industries, Inc., 2020) after a 167-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Mar 1, 2022
- Review
- 167 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925791 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK925791 Exac-Temp & Clini-Temp Probe W/Temperature SensorDeroyal Industries, Inc. · 1994 · Recalled
- 1 generation backK200631 DeRoyal Temperature Monitoring ProbeDeroyal Industries, Inc. · 2020
- This deviceK212945 Sterile Disposable Temperature ProbeShenzhen Envisen Industry Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925791 | Exac-Temp & Clini-Temp Probe W/Temperature Sensor | Deroyal Industries, Inc. | 1994 | 1 |
| −1 | K200631 | DeRoyal Temperature Monitoring Probe | Deroyal Industries, Inc. | 2020 | — |
| 0 (this device) | 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 |
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 26.8 · 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 |
|---|---|---|---|
| * | K200631 | DeRoyal Temperature Monitoring ProbeSummary page 4…Regulation Name Clinical Electronic Thermometer Product Code FLL 4. Predicate Device 1. DeRoyal Industries, Inc., DeRoyal Temperature Monitoring Probe under K200631. 5. Device Description Sterile Disposable Temperature Probes are used during patient temperature measurement. These probes consi… | 2020 |
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 28 years and passes through 2 companies; a new generation was cleared every 26.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K200631.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Sterile Disposable Temperature Probe is to be used with Mindray uMEC10 to monitor core temperature or skin temperature. The device is for use by licensed healthcare practitioners only.
The probe is offered in the following two configurations:
- Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities.
- Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface.
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/K212945 · printed Nov 3, 2026
Cite this page
510(k) Report. “K212945: Sterile Disposable Temperature Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K212945
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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