510(k) · Cleared
Recalled · Class II · 2013Disposable Temperature, Skin and Esophageal Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · FLL Continuous Measurement Thermometer
Cleared on Sep 20, 2005 as substantially equivalent to K925789 (Deroyal Industries, Inc., 1993) and 2 other predicates after a 71-day review. Its family tree reaches back 1 generation to 1993. 6 later devices descend from it. It has been recalled once.
- Decided
- Sep 20, 2005
- Review
- 71 days
- Class
- Class II
- Product code
- FLL
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K925789 (1993). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK925789 Debusk Temp. Syst. Esophageal StethoscopeDeroyal Industries, Inc. · 1993
- This deviceK051873 Disposable Temperature, Skin and Esophageal ProbesGE Healthcare · 2005
- Descendant · cites it directly · 5 of its ownK121999 General Purpose Temperature Probe, Skin Temperature ProbeDraeger Medical GmbH · 2013
- Descendant · 2 generations on · 2 of its ownK181967 Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK193338 Med-link Reusable Temperature Probes, Med-link Disposable…Shenzhen Med-Link Electronics Tech Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK182755 Disposable Temperature ProbeShenzhen Caremed Medical Technology Co., Ltd. · 2018
- Descendant · 4 generations on · 0 of its ownK223807 Reusable Temperature Probe, Disposable Temperature ProbeShenzhen Sino-K Medical Technology Co.,Ltd · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K121999General Purpose Temperature Probe, Skin Temperature ProbeDraeger Medical GmbH · 2013 · cites it directly5descendants
- K181967Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd. · 2018 · 2 generations on2descendants
- K193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature ProbesShenzhen Med-Link Electronics Tech Co., Ltd. · 2020 · 3 generations on1descendant
- K182755Disposable Temperature ProbeShenzhen Caremed Medical Technology Co., Ltd. · 2018 · 2 generations on1descendant
- K223807Reusable Temperature Probe, Disposable Temperature ProbeShenzhen Sino-K Medical Technology Co.,Ltd · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925789 | Debusk Temp. Syst. Esophageal Stethoscope | Deroyal Industries, Inc. | 1993 | — |
| 0 (this device) | K051873 | Disposable Temperature, Skin and Esophageal Probes | GE Healthcare | 2005 | — |
| +1 | K121999 | General Purpose Temperature Probe, Skin Temperature Probe | Draeger Medical GmbH | 2013 | — |
| +2 | K181967 | Disposable Temperature Probe | Shenzhen Launch Electrical Co., Ltd. | 2018 | — |
| +3 | K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2020 | — |
| +2 | K182755 | Disposable Temperature Probe | Shenzhen Caremed Medical Technology Co., Ltd. | 2018 | — |
| +4 | 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 |
|---|---|---|
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K925789 | Debusk Temp. Syst. Esophageal StethoscopeSummary page 2…M1024222, M1024205, M1024212, M1024215 and M1024218) are substantially equivalent in safety and effectiveness to the predicate DeRoyal temperature probes (K925789, K925006, K925791). DEVICE DESCRIPTION as required by 807.92(a)(4) Disposable temperature probes (Table below) are used… | 1993 |
| * | K925006 | Hydro-Temp Nicu and Skin Surface Temperature SensoSummary page 2…, M1024205, M1024212, M1024215 and M1024218) are substantially equivalent in safety and effectiveness to the predicate DeRoyal temperature probes (K925789, K925006, K925791). DEVICE DESCRIPTION as required by 807.92(a)(4) Disposable temperature probes (Table below) are used during p… | 1994 |
| * | K925791 | Exac-Temp & Clini-Temp Probe W/Temperature SensorSummary page 2…5, M1024212, M1024215 and M1024218) are substantially equivalent in safety and effectiveness to the predicate DeRoyal temperature probes (K925789, K925006, K925791). DEVICE DESCRIPTION as required by 807.92(a)(4) Disposable temperature probes (Table below) are used during patient te… | 1994 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121999 | General Purpose Temperature Probe, Skin Temperature Probe | 2013 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2013 | Class II | Z-1959-2013 | Use error | GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe, Disposable, 400 Series [M1024229]. GEs Disposable General Purpose 9FR Temperature Probe M1024229 is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
GP probes (REF M1024231 and M1024229: The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the esophagus or the rectum. It is sterile and individually packaged. It has a low-friction surface finish to make the insertion easier. The temperature probe beneath the cuff at the distal tip is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors…
Read the full statement (309 words)
GP probes (REF M1024231 and M1024229: The General Purpose Temperature Probe is intended for continuous temperature monitoring. The probe is inserted into the esophagus or the rectum. It is sterile and individually packaged. It has a low-friction surface finish to make the insertion easier. The temperature probe beneath the cuff at the distal tip is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.
Skin probe (REF M1024222): The Skin Temperature Probe is intended for monitoring the skin surface temperature. It is sterile and individually packaged. There is a temperature sensor affixed to the center of the foam material on the adhesive cover. The disk-shaped adhesive cover has a reflective backing and a hypo-allergenic adhesive which follows closely the contour of the skin. The skin temperature probe is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.
Esophageal probes (REF M1024205. M1024212. M1024215 and M1024218): The Esophageal Stethoscope with Temperature Probe is to be used for monitoring temperature, heart, and respiratory sounds on an anesthetized patient. The stethoscope tube is inserted into the esophagus. The probe is sterile, individually packaged and comes in different sizes. It has a low-friction surface finish to make the insertion easier, and a thin cuff to enhance sound transmission and fidelity. The stethoscope has a male luer fitting for attachment to a standard ear piece. The temperature probe, beneath the cuff at the distal tip, is designed for use with Datex-Ohmeda and GE Medical Systems IT monitoring systems and other monitors compatible with 400 Series temperature probes. The device is indicated for use by qualified medical personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051873: Disposable Temperature, Skin and Esophageal Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051873
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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