510(k) · Cleared
ClearedMed-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Med-Link Electronics Tech Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Aug 25, 2020 as substantially equivalent to K121427 (Unimed Medical Supplies, Inc., 2012) and 1 other predicate after a 267-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Aug 25, 2020
- Review
- 267 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K962070 (1996). 10 ancestors in all, the oldest K925789 (1993). 1 later device descends from it, 1 citing it directly.
- 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 backK181967 Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd. · 2018
- This deviceK193338 Med-link Reusable Temperature Probes, Med-link Disposable…Shenzhen Med-Link Electronics Tech Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK223807 Reusable Temperature Probe, Disposable Temperature ProbeShenzhen Sino-K Medical Technology Co.,Ltd · 2023
Most influential descendants
Showing 1 of 1 · See all- K223807Reusable Temperature Probe, Disposable Temperature ProbeShenzhen Sino-K Medical Technology Co.,Ltd · 2023 · cites it directly0descendants
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 | K181967 | Disposable Temperature Probe | Shenzhen Launch Electrical Co., Ltd. | 2018 | — |
| 0 (this device) | K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2020 | — |
| +1 | 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 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K121427 | Unimed Temperature ProbeSummary page 5…and Code regulation number Unimed Temperature Probe Temperature Unimed Class II, 21 CFR K121427 (Unimed Skin Temperature Probe Medical FLL 880.2910 1 Probe, Unimed Gene… | 2012 |
| * | K181967 | Disposable Temperature ProbeSummary page 5…Supplies Inc. Purpose Temperature Probe) Disposable Temperature Temperature Shenzhen Class II, 21 CFR K181967 Probe Probe Launch FLL 880.2910 2… | 2018 |
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 |
|---|---|---|---|
| K223807 | Reusable Temperature Probe, Disposable Temperature Probe | 2023 | 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 24 years and passes through 5 companies; a new generation was cleared every 7.8 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K223807 (Shenzhen Sino-K Medical Technology Co.,Ltd, 2023) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K121427.
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?
Med-link Reusable Temperature Probes: Med-link Temperature Probes are intended to be used for monitoring temperature for multi-patient use. The temperature probes are reusable and designed for use with monitors of Philips Model IntelliVueMP50, Mindray Model PM-9000 and Drager Model Infinity Gamma XL. These devices are used by qualified medical professional only. Med-link Disposable Temperature Probes: Med-link Disposable Temperature Probes are intended…
Read the full statement (99 words)
Med-link Reusable Temperature Probes:
Med-link Temperature Probes are intended to be used for monitoring temperature for multi-patient use. The temperature probes are reusable and designed for use with monitors of Philips Model IntelliVueMP50, Mindray Model PM-9000 and Drager Model Infinity Gamma XL.
These devices are used by qualified medical professional only.
Med-link Disposable Temperature Probes:
Med-link Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE Model B20 and Philips Model IntelliVueMP50.
These devices are used by qualified medical professional only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193338 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193338: Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193338
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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