510(k) · Cleared
Recalled · Class II · 2019Genius 2 Infrared Tympanic Electronic Thermometer, Model 303000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Healthcare Group LP · FLL Continuous Measurement Thermometer
Cleared on May 22, 2006 as substantially equivalent to K920713 (Intelligent Medical Systems, 1992) after a 70-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- May 22, 2006
- Review
- 70 days
- Class
- Class II
- Product code
- FLL
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920713 (1992). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK920713 Firsttemp GeniusIntelligent Medical Systems · 1992
- This deviceK060649 Genius 2 Infrared Tympanic Electronic Thermometer, Model 303000Tyco Healthcare Group LP · 2006
- Descendant · cites it directly · 2 of its ownK152659 V10Mediana Co., Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK170497 V10Mediana Co., Ltd. · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK200434 V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920713 | Firsttemp Genius | Intelligent Medical Systems | 1992 | — |
| 0 (this device) | K060649 | Genius 2 Infrared Tympanic Electronic Thermometer, Model 303000 | Tyco Healthcare Group LP | 2006 | — |
| +1 | K152659 | V10 | Mediana Co., Ltd. | 2016 | — |
| +2 | K170497 | V10 | Mediana Co., Ltd. | 2017 | 1 |
| +3 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K920713 | Firsttemp GeniusSummary page 1…l Equivalence is Claimed: The Kendall Genius 2 Infrared Tympanic Electronic Thermometer is substantially equivalent to the Kendall FirstTemp Genius Tympanic Thermometer (K920713) in intended use, materials, physical characteristics, and performance characteristics. The primary modifications attributed to t… | 1992 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152659 | V10 | 2016 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 28, 2019 | Class II | Z-0992-2020 | Under Investigation by firm | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers).… |
| Oct 28, 2019 | Class II | Z-0990-2020 | Under Investigation by firm | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers).… |
| Oct 28, 2019 | Class II | Z-0991-2020 | Under Investigation by firm | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers).… |
| Oct 28, 2019 | Class II | Z-0993-2020 | Under Investigation by firm | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers).… |
| Oct 28, 2019 | Class II | Z-0994-2020 | Under Investigation by firm | The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and 0.3C for Genius 3 thermometers).… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K152659 (Mediana 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 | — |
What is it indicated for?
The Kendall Genius 2 Infrared Tympanic Electronic Thermometer is intended for use in patients
in Acute and Alternate care settings to provide temperature measurements from the tympanic
membrane and equivalent measurements of oral, core, rectal, and axillary temperature based on
the tympanic reading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060649 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060649: Genius 2 Infrared Tympanic Electronic Thermometer, Model 303000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060649
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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