510(k) · Cleared
ClearedYU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yu Long Sheng Technology Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Jan 10, 2011 as substantially equivalent to K061007 (Good Medy Enterprise, Ltd., 2006) after a 131-day review. Its family tree reaches back 3 generations to 1987. 2 later devices descend from it.
- Decided
- Jan 10, 2011
- Review
- 131 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871465 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK871465 Thermometer SheathsAbco Dealers, Inc. · 1987
- 2 generations backK983406 Sanitherm Oral Disposable Thermometer Sheaths for Mercury…Banta Healthcare Group, Ltd. · 1998
- 1 generation backK061007 Good Medy, Disposable Thermometer SheathsGood Medy Enterprise, Ltd. · 2006
- This deviceK102508 YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02Yu Long Sheng Technology Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK202009 Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007…Shenzhen Juzhong Technology Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK180714 Probe Covers for ThermometersK-Jump Health Co., Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871465 | Thermometer Sheaths | Abco Dealers, Inc. | 1987 | — |
| −2 | K983406 | Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer… | Banta Healthcare Group, Ltd. | 1998 | — |
| −1 | K061007 | Good Medy, Disposable Thermometer Sheaths | Good Medy Enterprise, Ltd. | 2006 | — |
| 0 (this device) | K102508 | YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02 | Yu Long Sheng Technology Co., Ltd. | 2011 | — |
| +1 | K202009 | Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008… | Shenzhen Juzhong Technology Co., Ltd. | 2021 | — |
| +1 | K180714 | Probe Covers for Thermometers | K-Jump Health Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K061007 | Good Medy, Disposable Thermometer SheathsSummary page 1…eter Sheaths * Model: YLS5-01 for digital thermometer * Predicate Device: GOOD MEDYDisposable Thermometer Sheaths, K061007 4. Indications for Use: YLS-0I disposable thermometer sheath is intended for use as a barrier that is used as an… | 2006 |
What descends from it? (2)
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 24 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K202009 (Shenzhen Juzhong Technology Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K061007.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
YLS-01 is intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. This sheath is non-sterile and is intended for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102508: YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102508
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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