510(k) · Cleared
ClearedDisposable Ear Thermometer Probe Cover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huaian Zhongxin Packing Material Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Jul 28, 2021 as substantially equivalent to K101747 (Kaz USA, Inc (A Subsidiaryof Kaz Inc), 2010) after a 247-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Jul 28, 2021
- Review
- 247 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K031928 (2003). No later device cites it as a predicate yet.
- Root · 2 generations backK031928 Braun Thermoscan Pro 4000 Series (Professional Use Environment)…Braun GmbH · 2003
- 1 generation backK101747 Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000…Kaz USA, Inc (A Subsidiaryof Kaz Inc) · 2010
- This deviceK203431 Disposable Ear Thermometer Probe CoverHuaian Zhongxin Packing Material Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031928 | Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun… | Braun GmbH | 2003 | — |
| −1 | K101747 | Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model… | Kaz USA, Inc (A Subsidiaryof Kaz Inc) | 2010 | — |
| 0 (this device) | K203431 | Disposable Ear Thermometer Probe Cover | Huaian Zhongxin Packing Material Co., Ltd. | 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 |
|---|---|---|---|
| * | K101747 | Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model 6021791-Pro…Summary page 5…oscan® Pro 4000 Series/IRT 4000 Series 1 of page 4 510(k) Summary Thermometers 510(k) number: K101747 5.0 Device Description The Disposable Ear Thermometer Probe Cover is a disposable plastic cover made of a biocompatible… | 2010 |
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 18 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K101747.
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?
The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal.
The probe cover is provided non-sterile and for single 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/K203431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203431: Disposable Ear Thermometer Probe Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203431
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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