510(k) · Cleared
ClearedAvita Agil IT 101 Instant Digital Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avita Corporation · FLL Continuous Measurement Thermometer
Cleared on Sep 10, 2001 as substantially equivalent to K990168 (Microlife Systems AG, 1999) after a 63-day review. Its family tree reaches back 2 generations to 1995. 9 later devices descend from it.
- Decided
- Sep 10, 2001
- Review
- 63 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K943695 (1995). 9 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK943695 SuretempAdvanced Bioresearch Assoc. · 1995
- 1 generation backK990168 Microlife IT2CA1Microlife Systems AG · 1999
- This deviceK012136 Avita Agil IT 101 Instant Digital ThermometerAvita Corporation · 2001
- Descendant · cites it directly · 8 of its ownK031958 Microlife Instant Digital Electronic Thermometer, Model QT1JA1Microlife Intellectual Property GmbH · 2003
- Descendant · 2 generations on · 5 of its ownK043110 Microlife Instant Digital Electronic Thermometer, Model MT18L1Microlife Intellectual Property GmbH · 2004
- Descendant · 3 generations on · 3 of its ownK152975 VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company · 2016
- Descendant · 3 generations on · 2 of its ownK180131 Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018
- Descendant · 4 generations on · 1 of its ownK202791 iHealth Clinical Digital ThermometerAndon Health Co, Ltd. · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K031958Microlife Instant Digital Electronic Thermometer, Model QT1JA1Microlife Intellectual Property GmbH · 2003 · cites it directly8descendants
- K043110Microlife Instant Digital Electronic Thermometer, Model MT18L1Microlife Intellectual Property GmbH · 2004 · 2 generations on5descendants
- K152975VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company · 2016 · 3 generations on3descendants
- K180131Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018 · 3 generations on2descendants
- K202791iHealth Clinical Digital ThermometerAndon Health Co, Ltd. · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943695 | Suretemp | Advanced Bioresearch Assoc. | 1995 | — |
| −1 | K990168 | Microlife IT2CA1 | Microlife Systems AG | 1999 | — |
| 0 (this device) | K012136 | Avita Agil IT 101 Instant Digital Thermometer | Avita Corporation | 2001 | — |
| +1 | K031958 | Microlife Instant Digital Electronic Thermometer, Model QT1JA1 | Microlife Intellectual Property GmbH | 2003 | — |
| +2 | K043110 | Microlife Instant Digital Electronic Thermometer, Model MT18L1 | Microlife Intellectual Property GmbH | 2004 | — |
| +3 | K152975 | VDT985US Vicks SmartTemp Thermometer | Kaz USA, Inc., A Helen of Troy Company | 2016 | — |
| +3 | K180131 | Vicks RapidRead Digital Thermometer | Kaz USA, Inc., A Helen of Troy Company | 2018 | — |
| +4 | K202791 | iHealth Clinical Digital Thermometer | Andon Health Co, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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 26.8 · 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 |
|---|---|---|---|
| * | K990168 | Microlife IT2CA1Summary page 1…21568 001-886-2-8:121347 Mr. Geo Lin, General Manager AViTA Agil IT101 Instant Digital Thermometer Class 11 Microlife IT2CA1 Digital 4-Sec. Predicative Thermometer (K990168) AVITA Agil IT101 Instant Digital Thermometer is a hand-held, non-sterile, reusable clinical thermometer and is designed to inst… | 1999 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031958 | Microlife Instant Digital Electronic Thermometer, Model QT1JA1 | 2003 | 8 |
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 6 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K031958 (Microlife Intellectual Property GmbH, 2003) has gone furthest, with 8 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?
AVIiTA Agil IT101 Instant Lvigital Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm, by consumers in the home.
AvViTA Agil IT101 Instant Digital Thermometer is a hand-held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either rapid mode (4-seconds orally, 6-seconds rectally and under the arm -- Predicative Temperature), or standard mode(actual determination of temperature),
The device is to used and installed by people exception of handicapped persons and children.
The device is to used in the ENVIRONMENT of room temperature & normal environment condition.
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/K012136 · printed Nov 3, 2026
Cite this page
510(k) Report. “K012136: Avita Agil IT 101 Instant Digital Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K012136
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026