510(k) · Cleared
ClearedFilac Fas Temp Electronic Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Kendall Company · FLL Continuous Measurement Thermometer
Cleared on Jan 11, 2001 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jan 11, 2001
- Review
- 80 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK003313 Filac Fas Temp Electronic ThermometerThe Kendall Company · 2001
- Descendant · cites it directly · 2 of its ownK153135 Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK131818 Vital Signs MonitorEdan Instruments, Inc. · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK200434 V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK181919 Patient MonitorGuangdong Biolight Meditech Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK180380 vital signs monitorEdan Instruments, Inc. · 2018 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd. · 2016 · cites it directly2descendants
- K131818Vital Signs MonitorEdan Instruments, Inc. · 2013 · cites it directly1descendant
- K200434V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · cites it directly0descendants
- K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd. · 2019 · 2 generations on0descendants
- K180380vital signs monitorEdan Instruments, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003313 | Filac Fas Temp Electronic Thermometer | The Kendall Company | 2001 | — |
| +1 | K153135 | Vital Signs Monitor | Guangdong Biolight Meditech Co., Ltd. | 2016 | — |
| +1 | K131818 | Vital Signs Monitor | Edan Instruments, Inc. | 2013 | 2 |
| +1 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 1 |
| +2 | K181919 | Patient Monitor | Guangdong Biolight Meditech Co., Ltd. | 2019 | — |
| +2 | K180380 | vital signs monitor | Edan Instruments, Inc. | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 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? (7)
4 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?
- Of its descendants, K153135 (Guangdong Biolight Meditech Co., Ltd., 2016) has gone furthest, with 2 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/K003313 · printed Nov 5, 2026
Cite this page
510(k) Report. “K003313: Filac Fas Temp Electronic Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003313
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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