510(k) · Cleared
ClearedSanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral Disposable Thermometer Sheaths for
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Banta Healthcare Group, Ltd. · FLL Continuous Measurement Thermometer
Cleared on Oct 19, 1998 as substantially equivalent to K871465 (Abco Dealers, Inc., 1987) after a 21-day review. Its family tree reaches back 1 generation to 1987. 12 later devices descend from it.
- Decided
- Oct 19, 1998
- Review
- 21 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K871465 (1987). 12 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK871465 Thermometer SheathsAbco Dealers, Inc. · 1987
- This deviceK983406 Sanitherm Oral Disposable Thermometer Sheaths for Mercury…Banta Healthcare Group, Ltd. · 1998
- Descendant · cites it directly · 5 of its ownK061007 Good Medy, Disposable Thermometer SheathsGood Medy Enterprise, Ltd. · 2006
- Descendant · 2 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 · cites it directly · 1 of its ownK183431 Medline Digital Rectal Thermometer SheathMedline Industries, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK112289 Disposable Thermometer Covers and SheathsKang ZE Industrial Co. Limited · 2011
- Descendant · cites it directly · 1 of its ownK063418 Acon Digital Thermometer Probe CoversACON Laboratories, Inc. · 2007
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K061007Good Medy, Disposable Thermometer SheathsGood Medy Enterprise, Ltd. · 2006 · cites it directly5descendants
- K102508YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02Yu Long Sheng Technology Co., Ltd. · 2011 · 2 generations on2descendants
- K183431Medline Digital Rectal Thermometer SheathMedline Industries, Inc. · 2019 · cites it directly1descendant
- K112289Disposable Thermometer Covers and SheathsKang ZE Industrial Co. Limited · 2011 · cites it directly1descendant
- K063418Acon Digital Thermometer Probe CoversACON Laboratories, Inc. · 2007 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871465 | Thermometer Sheaths | Abco Dealers, Inc. | 1987 | — |
| 0 (this device) | 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 | — |
| +2 | K102508 | YU Long Sheng Disposable Thermometer Sheaths, Models Yls-01 and Yls-02 | Yu Long Sheng Technology Co., Ltd. | 2011 | — |
| +1 | K183431 | Medline Digital Rectal Thermometer Sheath | Medline Industries, Inc. | 2019 | — |
| +1 | K112289 | Disposable Thermometer Covers and Sheaths | Kang ZE Industrial Co. Limited | 2011 | — |
| +1 | K063418 | Acon Digital Thermometer Probe Covers | ACON Laboratories, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K871465 | Thermometer SheathsSummary page 2…ded for single patient use only. 10. Substantial Equivalence These devices are substantially equivalent to other similar devices currently on the market. (Abco Dealers, K871465 and Medline Industries, Inc., K772385). Banta Digital and Mercury Thermometer Sheaths are identical in respect to materials, cons… | 1987 |
| Kept off the family tree | K772385 | FDA’s K772385 is Thin-Bladed Nasal Speculum Our OCR of the scanned summary read K772385, FDA’s number for Thin-Bladed Nasal Speculum (Edward Weck, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Medline Industries, Inc.”. Kept off the family tree. Summary page 2…Substantial Equivalence These devices are substantially equivalent to other similar devices currently on the market. (Abco Dealers, K871465 and Medline Industries, Inc., K772385). Banta Digital and Mercury Thermometer Sheaths are identical in respect to materials, construction and manufacturing process. Si… | 1978 |
What descends from it? (12)
See all 127 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061007 | Good Medy, Disposable Thermometer Sheaths | 2006 | 5 |
| K183431 | Medline Digital Rectal Thermometer Sheath | 2019 | 1 |
| K112289 | Disposable Thermometer Covers and Sheaths | 2011 | 1 |
| K063418 | Acon Digital Thermometer Probe Covers | 2007 | 1 |
| K083419 | Actherm Digital Clinical Thermometer Probe Covers, Model (S) MEDACCU1010, MEDACCU1010-1… | 2009 | 0 |
| K011929 | Handpiece Sheath-Model #A910 | 2001 | 0 |
| K994211 | Acucam Intraoral Camera Sheaths, Models 023545, 601111, 300407, 601285 | 2000 | 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?
- Its one ancestor has no recall.
- Of its descendants, K061007 (Good Medy Enterprise, Ltd., 2006) has gone furthest, with 5 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 | — |
What is it indicated for?
These devices are indicated for use as a barrier that is used as an accessory to oral or rectal, digital or mercury thermometers, These sheaths are non-sterile and are Intended for single patlent use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983406 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983406: Sanitherm Oral Disposable Thermometer Sheaths for Mercury Thermometer, Senitherm Oral Disposable Thermometer Sheaths for.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983406
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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