510(k) · Cleared
Recalled · Class II · 2026Exac-Temp & Clini-Temp Tympanic & Myocardial 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 Apr 8, 1994 after a 508-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Apr 8, 1994
- Review
- 508 days
- Class
- Class II
- Product code
- FLL
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK925792 Exac-Temp & Clini-Temp Tympanic & Myocardial ProbeDeroyal Industries, Inc. · 1994
- Descendant · cites it directly · 2 of its ownK200631 DeRoyal Temperature Monitoring ProbeDeroyal Industries, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK251160 Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A…Shenzhen Med-Link Electronics Tech Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK212945 Sterile Disposable Temperature ProbeShenzhen Envisen Industry Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK061942 Tympanic Temperature Probe with Foam, Model M1024233; Without Foam…GE Healthcare · 2006
Most influential descendants
Showing 4 of 4 · See all- K200631DeRoyal Temperature Monitoring ProbeDeroyal Industries, Inc. · 2020 · cites it directly2descendants
- K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS…Shenzhen Med-Link Electronics Tech Co., Ltd. · 2026 · 2 generations on0descendants
- K212945Sterile Disposable Temperature ProbeShenzhen Envisen Industry Co., Ltd. · 2022 · 2 generations on0descendants
- K061942Tympanic Temperature Probe with Foam, Model M1024233; Without Foam Model M1024237GE Healthcare · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925792 | Exac-Temp & Clini-Temp Tympanic & Myocardial Probe | Deroyal Industries, Inc. | 1994 | — |
| +1 | K200631 | DeRoyal Temperature Monitoring Probe | Deroyal Industries, Inc. | 2020 | — |
| +2 | K251160 | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P… | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2026 | — |
| +2 | K212945 | Sterile Disposable Temperature Probe | Shenzhen Envisen Industry Co., Ltd. | 2022 | — |
| +1 | K061942 | Tympanic Temperature Probe with Foam, Model M1024233; Without Foam Model… | GE Healthcare | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2026 | Class II | Z-3256-2026 | Under Investigation by firm | Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K200631 (Deroyal Industries, Inc., 2020) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K925792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925792: Exac-Temp & Clini-Temp Tympanic & Myocardial Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925792
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026