510(k) · Cleared
ClearedGeneral Purpose Temperature Probe, Skin Temperature Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical GmbH · FLL Continuous Measurement Thermometer
Cleared on Feb 28, 2013 as substantially equivalent to K946306 (Siemens Medical Solutions USA, Inc., 1995) and 2 other predicates after a 234-day review. Its family tree reaches back 2 generations to 1996. 5 later devices descend from it.
- Decided
- Feb 28, 2013
- Review
- 234 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K962070 (1996). 7 ancestors in all, the oldest K925789 (1993). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK962070 Ysi 400 Series Atuoclavable Reusable Temperature ProbeYellow Springs Instrument Co., Inc. · 1996 · Recalled
- 1 generation backK050837 Reusable Temperature Probes (M1024254 Skin Temperature Probe…GE Healthcare · 2005
- This deviceK121999 General Purpose Temperature Probe, Skin Temperature ProbeDraeger Medical GmbH · 2013
- Descendant · cites it directly · 2 of its ownK181967 Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK193338 Med-link Reusable Temperature Probes, Med-link Disposable…Shenzhen Med-Link Electronics Tech Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK182755 Disposable Temperature ProbeShenzhen Caremed Medical Technology Co., Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK223807 Reusable Temperature Probe, Disposable Temperature ProbeShenzhen Sino-K Medical Technology Co.,Ltd · 2023
- Descendant · 2 generations on · 0 of its ownK193625 Disposable Temperature ProbeShenzhen Changke Connect Electronics Co., Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K181967Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd. · 2018 · cites it directly2descendants
- K193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature ProbesShenzhen Med-Link Electronics Tech Co., Ltd. · 2020 · 2 generations on1descendant
- K182755Disposable Temperature ProbeShenzhen Caremed Medical Technology Co., Ltd. · 2018 · cites it directly1descendant
- K223807Reusable Temperature Probe, Disposable Temperature ProbeShenzhen Sino-K Medical Technology Co.,Ltd · 2023 · 3 generations on0descendants
- K193625Disposable Temperature ProbeShenzhen Changke Connect Electronics Co., Ltd. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962070 | Ysi 400 Series Atuoclavable Reusable Temperature Probe | Yellow Springs Instrument Co., Inc. | 1996 | 2 |
| −1 | K050837 | Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable… | GE Healthcare | 2005 | — |
| 0 (this device) | K121999 | General Purpose Temperature Probe, Skin Temperature Probe | Draeger Medical GmbH | 2013 | — |
| +1 | K181967 | Disposable Temperature Probe | Shenzhen Launch Electrical Co., Ltd. | 2018 | — |
| +2 | K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2020 | — |
| +1 | K182755 | Disposable Temperature Probe | Shenzhen Caremed Medical Technology Co., Ltd. | 2018 | — |
| +3 | K223807 | Reusable Temperature Probe, Disposable Temperature Probe | Shenzhen Sino-K Medical Technology Co.,Ltd | 2023 | — |
| +2 | 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 |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K946306 | Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSummary page 2…z- ~-- ~~ ~ . mr-jj C50IriinbLd ame ,'f___________ K946306 SC 9000 Bedside Monitor, SC 9015 Bedside Driger (former Siemens) _____________Monitoring… | 1995 |
| * | K050837 | Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable; M1024247, GP…Summary page 2…ide Monitor, SC 9015 Bedside Driger (former Siemens) _____________Monitoring System Reusable temperature probes (Skin K050837 Temperature Probe, reusable; General GE HEALTHCARE Purpose Tempera… | 2005 |
| * | K051873 | Disposable Temperature, Skin and Esophageal ProbesSummary page 2…bes (Skin K050837 Temperature Probe, reusable; General GE HEALTHCARE Purpose Temperature Probe, reusable K051 873 Disposable temperature, Skin andGEHATCR Oesophageal probesGEHATCR K0039Disposable temperature probes/ sen… | 2005 |
| * | — | Disposable temperature probes/sensors Named without a submission number | |
| * | — | Instrument cables Named without a submission number |
What descends from it? (5)
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)
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 17 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K181967 (Shenzhen Launch Electrical Co., Ltd., 2018) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K946306.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
General Purpose Temperature probes
Driger disposable general purpose temperature probes are intended for patient core body temperature measurement in combination with Driger and Siemens patient monitoring systems. The probes are inserted into the oesophagus or the rectum.
Skin Temperature probes
Driger disposable skin temperature probes are intended for patient skin temperature measurement in combination with Driger and Siemens patient monitoring systems. The probes are affixed on the patients skin with an adhesive cover.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121999 · printed Nov 4, 2026
Cite this page
510(k) Report. “K121999: General Purpose Temperature Probe, Skin 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/K121999
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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