510(k) · Cleared
ClearedDual Mode Infrared Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelliworks, LLC · FLL Continuous Measurement Thermometer
Cleared on Apr 6, 2017 as substantially equivalent to K113141 (Microlife Intellectual Property GmbH, 2012) and 1 other predicate after a 136-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Apr 6, 2017
- Review
- 136 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K000969 (2000). 10 ancestors in all, the oldest K983295 (1999). No later device cites it as a predicate yet.
- Root · 5 generations backK000969 Microlife Digital Infrared Ear Thermometer, Model IR1DA1Microlife Corp. · 2000
- 4 generations backK020725 Microlife Digital Infrared Ear Thermometer, Model IR1DE1Microlife Corp. · 2002
- 3 generations backK034023 Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1Microlife Intellectual Property GmbH · 2004
- 2 generations backK091040 Microlife Digital Infrared Ear Thermometer, Model Iridvi-1Microlife Intellectual Property GmbH · 2009
- 1 generation backK113141 Microlife Dual Mode Thermometer,Model IFR1MJ1Microlife Intellectual Property GmbH · 2012
- This deviceK163256 Dual Mode Infrared ThermometerIntelliworks, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000969 | Microlife Digital Infrared Ear Thermometer, Model IR1DA1 | Microlife Corp. | 2000 | — |
| −4 | K020725 | Microlife Digital Infrared Ear Thermometer, Model IR1DE1 | Microlife Corp. | 2002 | — |
| −3 | K034023 | Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 | Microlife Intellectual Property GmbH | 2004 | — |
| −2 | K091040 | Microlife Digital Infrared Ear Thermometer, Model Iridvi-1 | Microlife Intellectual Property GmbH | 2009 | — |
| −1 | K113141 | Microlife Dual Mode Thermometer,Model IFR1MJ1 | Microlife Intellectual Property GmbH | 2012 | — |
| 0 (this device) | K163256 | Dual Mode Infrared Thermometer | Intelliworks, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113141 | Microlife Dual Mode Thermometer,Model IFR1MJ1Summary page 4…: II Regulation Number: 21 CFR 880.2910 3. Predicate Devices Predicate device #1: Microlife Dual Mode Thermometer, Model IFR1MJ1 510(k) Number: K113141 Predicate device #2: easystem duo, Dual Thermometer, Forehead/Ear, Model BT-021 510(k) Number: K033077 4. Devic… | 2012 |
| * | K033077 | Easytem Duo, Forehead/Ear Thermometer, Model BT-021Summary page 4…Thermometer, Model IFR1MJ1 510(k) Number: K113141 Predicate device #2: easystem duo, Dual Thermometer, Forehead/Ear, Model BT-021 510(k) Number: K033077 4. Device Description The Dual Mode Infrared Thermometer (Model DM-IR200) is a hand-held, non-sterile, reusable, bat… | 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 17 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 10 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. 2017, 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 Dual Mode Infrared Thermometer (Model DM-IR200) is intended for the intermittent measurement and monitoring of human body temperatures. It is for non-professional use by consumers at home. The ear canal mode is indicated for use by people above one year old and the skin/forehead mode is indicated for use by people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163256 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163256: Dual Mode Infrared Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163256
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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