510(k) · Cleared
ClearedDisposable Temperature Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Launch Electrical Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Dec 10, 2018 as substantially equivalent to K121999 (Draeger Medical GmbH, 2013) after a 140-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it.
- Decided
- Dec 10, 2018
- Review
- 140 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). 2 later devices descend 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 deviceK181967 Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK193338 Med-link Reusable Temperature Probes, Med-link Disposable…Shenzhen Med-Link Electronics Tech Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK223807 Reusable Temperature Probe, Disposable Temperature ProbeShenzhen Sino-K Medical Technology Co.,Ltd · 2023
Most influential descendants
Showing 2 of 2 · See all- K193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature ProbesShenzhen Med-Link Electronics Tech Co., Ltd. · 2020 · cites it directly1descendant
- K223807Reusable Temperature Probe, Disposable Temperature ProbeShenzhen Sino-K Medical Technology Co.,Ltd · 2023 · 2 generations on0descendants
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) | K181967 | Disposable Temperature Probe | Shenzhen Launch Electrical Co., Ltd. | 2018 | — |
| +1 | K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2020 | — |
| +2 | K223807 | Reusable Temperature Probe, Disposable Temperature Probe | Shenzhen Sino-K Medical Technology Co.,Ltd | 2023 | — |
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 |
| 2023 | 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…vice Sponsor Dräger Medical GmbH Device Name and Model Temperature Probes (General purpose/ Skin) 510(k) Number K121999 Product Code FLL Regulation Number 21 CFR 880.2910 Regulation Class II… | 2013 |
| † | K140134 | Esophageal Stethoscope with Temperature Sensor (Non-Sterile),Esophageal Stethoscope… | 2014 |
| † | K030580 | Suretemp Plus | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | 2020 | 1 |
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, K193338 (Shenzhen Med-Link Electronics Tech Co., Ltd., 2020) has gone furthest, with 1 descendant 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?
The Disposable Temperature Probe (body surface type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's skin temperature.
The Disposable Temperature Probe (celomic type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's oral, rectal, nasopharyngeal cavity temperature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181967 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181967: 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/K181967
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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