510(k) · Cleared
ClearedMedline Digital Thermometer Non-Lubricated Probe Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · FLL Continuous Measurement Thermometer
Cleared on Sep 20, 2021 as substantially equivalent to K183431 (Medline Industries, Inc., 2019) after a 90-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Sep 20, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871465 (1987). No later device cites it as a predicate yet.
- 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 backK183431 Medline Digital Rectal Thermometer SheathMedline Industries, Inc. · 2019
- This deviceK211931 Medline Digital Thermometer Non-Lubricated Probe SheathMedline Industries, Inc. · 2021
View 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 | K183431 | Medline Digital Rectal Thermometer Sheath | Medline Industries, Inc. | 2019 | — |
| 0 (this device) | K211931 | Medline Digital Thermometer Non-Lubricated Probe Sheath | Medline Industries, Inc. | 2021 | — |
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 |
|---|---|---|---|
| * | K183431 | Medline Digital Rectal Thermometer SheathSummary page 4…uct Code: FLL Classification Panel: General Hospital Regulatory Class: II Regulation Number: 21 CFR 880.2910 Predicate Device Medline Digital Rectal Thermometer Sheath, K183431 Device Description The Medline Digital Thermometer Non-Lubricated Probe Sheath is an accessory to a clinical electronic thermome… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
These devices are indicated for use as a barrier accessory to digital thermometers while taking rectal, oral or axillary temperature measurements. These sheaths are non-sterile and intended for single use only. This accessory is contraindicated for use with broken skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211931: Medline Digital Thermometer Non-Lubricated Probe Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211931
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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