510(k) · Cleared
ClearedAmplife Digital Infrared Ear Thermometer, Model E101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amplife Corporation · FLL Continuous Measurement Thermometer
Cleared on Nov 19, 2004 as substantially equivalent to K034023 (Microlife Intellectual Property GmbH, 2004) after a 29-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Nov 19, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000969 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK000969 Microlife Digital Infrared Ear Thermometer, Model IR1DA1Microlife Corp. · 2000
- 2 generations backK020725 Microlife Digital Infrared Ear Thermometer, Model IR1DE1Microlife Corp. · 2002
- 1 generation backK034023 Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1Microlife Intellectual Property GmbH · 2004
- This deviceK042906 Amplife Digital Infrared Ear Thermometer, Model E101Amplife Corporation · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000969 | Microlife Digital Infrared Ear Thermometer, Model IR1DA1 | Microlife Corp. | 2000 | — |
| −2 | K020725 | Microlife Digital Infrared Ear Thermometer, Model IR1DE1 | Microlife Corp. | 2002 | — |
| −1 | K034023 | Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 | Microlife Intellectual Property GmbH | 2004 | — |
| 0 (this device) | K042906 | Amplife Digital Infrared Ear Thermometer, Model E101 | Amplife Corporation | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 26.7 · 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 |
|---|---|---|---|
| * | K034023 | Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1Summary page 1…eter/Clinical Electronic Thermometer 3. Predicate Device Information: Microlife Intellectual Property GmBH Infrared Ear Thermometer, Model IRI DEl-1, K# 034023. 4. Device Description: The AMPLIFE Digital Infrared Ear Thermometer, Model E100 is a digital infrared Ear Therm… | 2004 |
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 4 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K034023.
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 AMPLIFE Digital Infrared Ear Thermometer, Model El00, is a Digital Infrared Ear Thermometer (without probe cover) using an infrared sensor to detect body temperature from the ear in the neonatal, pediatric and adult population used in the home setting.
The device is used without a probe cover.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042906 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042906: Amplife Digital Infrared Ear Thermometer, Model E101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042906
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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