510(k) · Cleared
ClearedDisposable Temperature Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Changke Connect Electronics Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Jul 24, 2020 as substantially equivalent to K182755 (Shenzhen Caremed Medical Technology Co., Ltd., 2018) after a 211-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Jul 24, 2020
- Review
- 211 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K962070 (1996). 9 ancestors in all, the oldest K925789 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK962070 Ysi 400 Series Atuoclavable Reusable Temperature ProbeYellow Springs Instrument Co., Inc. · 1996 · Recalled
- 3 generations backK050837 Reusable Temperature Probes (M1024254 Skin Temperature Probe…GE Healthcare · 2005
- 2 generations backK121999 General Purpose Temperature Probe, Skin Temperature ProbeDraeger Medical GmbH · 2013
- 1 generation backK182755 Disposable Temperature ProbeShenzhen Caremed Medical Technology Co., Ltd. · 2018
- This deviceK193625 Disposable Temperature ProbeShenzhen Changke Connect Electronics Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962070 | Ysi 400 Series Atuoclavable Reusable Temperature Probe | Yellow Springs Instrument Co., Inc. | 1996 | 2 |
| −3 | K050837 | Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable… | GE Healthcare | 2005 | — |
| −2 | K121999 | General Purpose Temperature Probe, Skin Temperature Probe | Draeger Medical GmbH | 2013 | — |
| −1 | K182755 | Disposable Temperature Probe | Shenzhen Caremed Medical Technology Co., Ltd. | 2018 | — |
| 0 (this device) | K193625 | Disposable Temperature Probe | Shenzhen Changke Connect Electronics Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K182755 | Disposable Temperature ProbeSummary page 4…Submission type Traditional 510(K) 4. Predicate Device Manufacturer: Shenzhen Caremed Medical Technology Co., Ltd. Device: Disposable Temperature Probe K#: K182755 P a g e | 2 of 4 K19… | 2018 |
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 24 years and passes through 5 companies; a new generation was cleared every 7.8 years on median.
- 4 of the 9 ancestors have a recall of any class.
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 disposable rectal temperature probes are intended to be used for continually monitoring temperature for up to 10 minutes from the rectum of adults, the probes may be used for up to 24 hours.
The temperature probes are non-sterile and designed for single patient use with monitors of EDAN model iM50. These devices are indicated for use by qualified medical personnel in hospital environment.
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/K193625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193625: Disposable Temperature Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193625
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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