510(k) · Cleared
ClearedGood Medy, Disposable Thermometer Sheaths
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Good Medy Enterprise, Ltd. · FLL Continuous Measurement Thermometer
Cleared on Jun 14, 2006 as substantially equivalent to K983406 (Banta Healthcare Group, Ltd., 1998) after a 64-day review. Its family tree reaches back 2 generations to 1987. 5 later devices descend from it.
- Decided
- Jun 14, 2006
- Review
- 64 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871465 (1987). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK871465 Thermometer SheathsAbco Dealers, Inc. · 1987
- 1 generation backK983406 Sanitherm Oral Disposable Thermometer Sheaths for Mercury…Banta Healthcare Group, Ltd. · 1998
- This deviceK061007 Good Medy, Disposable Thermometer SheathsGood Medy Enterprise, Ltd. · 2006
- Descendant · cites it directly · 2 of its ownK102508 YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02Yu Long Sheng Technology Co., Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK112289 Disposable Thermometer Covers and SheathsKang ZE Industrial Co. Limited · 2011
- Descendant · 2 generations on · 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 · 2 generations on · 0 of its ownK180714 Probe Covers for ThermometersK-Jump Health Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK152690 Disposable Thermometer Probe SheathsPinghu Sama Medical Packing Co., Ltd. · 2016
Most influential descendants
Showing 5 of 5 · See all- K102508YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02Yu Long Sheng Technology Co., Ltd. · 2011 · cites it directly2descendants
- K112289Disposable Thermometer Covers and SheathsKang ZE Industrial Co. Limited · 2011 · cites it directly1descendant
- K202009Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009…Shenzhen Juzhong Technology Co., Ltd. · 2021 · 2 generations on0descendants
- K180714Probe Covers for ThermometersK-Jump Health Co., Ltd. · 2018 · 2 generations on0descendants
- K152690Disposable Thermometer Probe SheathsPinghu Sama Medical Packing Co., Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871465 | Thermometer Sheaths | Abco Dealers, Inc. | 1987 | — |
| −1 | K983406 | Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer… | Banta Healthcare Group, Ltd. | 1998 | — |
| 0 (this device) | K061007 | Good Medy, Disposable Thermometer Sheaths | Good Medy Enterprise, Ltd. | 2006 | — |
| +1 | K102508 | YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02 | Yu Long Sheng Technology Co., Ltd. | 2011 | — |
| +1 | K112289 | Disposable Thermometer Covers and Sheaths | Kang ZE Industrial Co. Limited | 2011 | — |
| +2 | K202009 | Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008… | Shenzhen Juzhong Technology Co., Ltd. | 2021 | — |
| +2 | K180714 | Probe Covers for Thermometers | K-Jump Health Co., Ltd. | 2018 | — |
| +2 | K152690 | Disposable Thermometer Probe Sheaths | Pinghu Sama Medical Packing Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2016 | 1 | 0 |
| 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 26.8 · 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 |
|---|---|---|---|
| * | K983406 | Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral…Summary page 1…sable Thermometer Sheaths * Common name of device: Disposable Thermometer Sheaths * Predicate Device: Sanitherm Oral Disposable Thermometer Sheaths, K983406 Indications for Use: The devices are intended for use as a barrier that is used as an accessory to oral or rectal for digi… | 1998 |
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 19 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K102508 (Yu Long Sheng Technology Co., Ltd., 2011) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K983406.
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?
The devices are intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. These sheaths are non-sterile and are intended for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K061007: Good Medy, Disposable Thermometer Sheaths.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K061007
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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