510(k) · Cleared
ClearedThermometer Sheaths
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abco Dealers, Inc. · FLL Continuous Measurement Thermometer
Cleared on May 11, 1987 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- May 11, 1987
- Review
- 27 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly.
- This deviceK871465 Thermometer SheathsAbco Dealers, Inc. · 1987
- Descendant · cites it directly · 12 of its ownK983406 Sanitherm Oral Disposable Thermometer Sheaths for Mercury…Banta Healthcare Group, Ltd. · 1998
- Descendant · 2 generations on · 5 of its ownK061007 Good Medy, Disposable Thermometer SheathsGood Medy Enterprise, Ltd. · 2006
- Descendant · 3 generations on · 2 of its ownK102508 YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02Yu Long Sheng Technology Co., Ltd. · 2011
- Descendant · 2 generations on · 1 of its ownK183431 Medline Digital Rectal Thermometer SheathMedline Industries, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK112289 Disposable Thermometer Covers and SheathsKang ZE Industrial Co. Limited · 2011
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K983406Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral…Banta Healthcare Group, Ltd. · 1998 · cites it directly12descendants
- K061007Good Medy, Disposable Thermometer SheathsGood Medy Enterprise, Ltd. · 2006 · 2 generations on5descendants
- K102508YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02Yu Long Sheng Technology Co., Ltd. · 2011 · 3 generations on2descendants
- K183431Medline Digital Rectal Thermometer SheathMedline Industries, Inc. · 2019 · 2 generations on1descendant
- K112289Disposable Thermometer Covers and SheathsKang ZE Industrial Co. Limited · 2011 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K871465 | Thermometer Sheaths | Abco Dealers, Inc. | 1987 | — |
| +1 | K983406 | Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer… | Banta Healthcare Group, Ltd. | 1998 | — |
| +2 | K061007 | Good Medy, Disposable Thermometer Sheaths | Good Medy Enterprise, Ltd. | 2006 | — |
| +3 | K102508 | YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02 | Yu Long Sheng Technology Co., Ltd. | 2011 | — |
| +2 | K183431 | Medline Digital Rectal Thermometer Sheath | Medline Industries, Inc. | 2019 | — |
| +2 | K112289 | Disposable Thermometer Covers and Sheaths | Kang ZE Industrial Co. Limited | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983406 | Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral… | 1998 | 12 |
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?
- Of its descendants, K983406 (Banta Healthcare Group, Ltd., 1998) has gone furthest, with 12 descendants of its own.
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 | — |
https://510kreport.com/device/K871465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K871465: Thermometer Sheaths.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K871465
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026