510(k) · Cleared
ClearedDisposable Temperature Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Caremed Medical Technology Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Dec 21, 2018 as substantially equivalent to K121999 (Draeger Medical GmbH, 2013) after an 84-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Dec 21, 2018
- Review
- 84 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962070 (1996). 8 ancestors in all, the oldest K925789 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK962070 Ysi 400 Series Atuoclavable Reusable Temperature ProbeYellow Springs Instrument Co., Inc. · 1996 · Recalled
- 2 generations backK050837 Reusable Temperature Probes (M1024254 Skin Temperature Probe…GE Healthcare · 2005
- 1 generation backK121999 General Purpose Temperature Probe, Skin Temperature ProbeDraeger Medical GmbH · 2013
- This deviceK182755 Disposable Temperature ProbeShenzhen Caremed Medical Technology Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK193625 Disposable Temperature ProbeShenzhen Changke Connect Electronics Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K193625Disposable Temperature ProbeShenzhen Changke Connect Electronics Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962070 | Ysi 400 Series Atuoclavable Reusable Temperature Probe | Yellow Springs Instrument Co., Inc. | 1996 | 2 |
| −2 | K050837 | Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable… | GE Healthcare | 2005 | — |
| −1 | K121999 | General Purpose Temperature Probe, Skin Temperature Probe | Draeger Medical GmbH | 2013 | — |
| 0 (this device) | K182755 | Disposable Temperature Probe | Shenzhen Caremed Medical Technology Co., Ltd. | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K121999 | General Purpose Temperature Probe, Skin Temperature ProbeSummary page 4…clinical / FLL Submission type Traditional 510(K) 4. Predicate Device Draeger Medical GmbH, General Purpose Temperature Probe, Skin Temperature Probe under K121999. 5. Device Description Disposable temperature probes are used during patient temperature measurement. These probes consist o… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193625 | Disposable Temperature Probe | 2020 | 0 |
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 22 years and passes through 4 companies; a new generation was cleared every 7.8 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K193625 (Shenzhen Changke Connect Electronics Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K121999.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Rectal Temperature Probe:
The Disposable Rectal Temperature Probes are intended to be used for monitoring temperature from the rectum. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.
Skin Temperature Probe:
The Disposable Skin Temperature Probes are intended to be used for monitoring temperature from skin. The temperature probes are non-sterile and designed for single patient use with monitors of Nihon Kohden model BSM-5135A. These devices are indicated for use by qualified medical personnel only.
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/K182755 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182755: Disposable Temperature Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182755
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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