510(k) · Cleared

Cleared

Microlife IT2CA1

K990168510(k) AbbreviatedCleared Feb 25, 199937-day reviewClass II21 CFR 880.2910

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Microlife Systems AG · FLL Continuous Measurement Thermometer

Cleared on Feb 25, 1999 as substantially equivalent to K943695 (Advanced Bioresearch Assoc., 1995) after a 37-day review. Its family tree reaches back 1 generation to 1995. 10 later devices descend from it.

Decided: Feb 25, 1999
Review: 37 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K943695 (1995). 10 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK943695 SuretempAdvanced Bioresearch Assoc. · 1995
This deviceK990168 Microlife IT2CA1Microlife Systems AG · 1999
Descendant · cites it directly · 9 of its ownK012136 Avita Agil IT 101 Instant Digital ThermometerAvita Corporation · 2001
Descendant · 2 generations on · 8 of its ownK031958 Microlife Instant Digital Electronic Thermometer, Model QT1JA1Microlife Intellectual Property GmbH · 2003
Descendant · 3 generations on · 5 of its ownK043110 Microlife Instant Digital Electronic Thermometer, Model MT18L1Microlife Intellectual Property GmbH · 2004
Descendant · 4 generations on · 3 of its ownK152975 VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company · 2016
Descendant · 4 generations on · 2 of its ownK180131 Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2001high 2 (2003) · low 0 (2002)2026

Most influential descendants

Showing 5 of 10 · See all

K012136Avita Agil IT 101 Instant Digital ThermometerAvita Corporation · 2001 · cites it directly9descendants
K031958Microlife Instant Digital Electronic Thermometer, Model QT1JA1Microlife Intellectual Property GmbH · 2003 · 2 generations on8descendants
K043110Microlife Instant Digital Electronic Thermometer, Model MT18L1Microlife Intellectual Property GmbH · 2004 · 3 generations on5descendants
K152975VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company · 2016 · 4 generations on3descendants
K180131Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943695	Suretemp	Advanced Bioresearch Assoc.	1995	—
0 (this device)	K990168	Microlife IT2CA1	Microlife Systems AG	1999	—
+1	K012136	Avita Agil IT 101 Instant Digital Thermometer	Avita Corporation	2001	—
+2	K031958	Microlife Instant Digital Electronic Thermometer, Model QT1JA1	Microlife Intellectual Property GmbH	2003	—
+3	K043110	Microlife Instant Digital Electronic Thermometer, Model MT18L1	Microlife Intellectual Property GmbH	2004	—
+4	K152975	VDT985US Vicks SmartTemp Thermometer	Kaz USA, Inc., A Helen of Troy Company	2016	—
+4	K180131	Vicks RapidRead Digital Thermometer	Kaz USA, Inc., A Helen of Troy Company	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	2	0
2004	1	0
2006	1	0
2007	1	0
2016	1	0
2018	1	0
2021	2	0

FIG. 1 — Lineage of K990168, 1995–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K943695	Suretemp Summary page 1 …910 Clinical Electronic Thermometer (To be manufactured and marketed for Consumer home use) Predicate Device: SureTemp® Welch Allyn, Inc. 510(k) Document Control Number K943695 Description of the Device: The MicrolLife IT2CA1 Digital 4-Sec Predictive Thermometer is the first predictive "Consumer Version…	Advanced Bioresearch Assoc.	1995	—

Also cleared against K943695: 3 other devices →

What descends from it? (10)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012136	Avita Agil IT 101 Instant Digital Thermometer	Avita Corporation	2001	9

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?

Its one ancestor has no recall.
Of its descendants, K012136 (Avita Corporation, 2001) has gone furthest, with 9 descendants of its own.
3 other devices also cite its predicate K943695.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLL

6in 2025

2007high 43 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLL

131in 2025

2007high 295 (2023) · low 59 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FLL

1in 2025

2007high 5 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FLL

73in 2025

2007high 142 (2022) · low 4 (2007)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 IT2CA1 is used in a home use environment tQ make an accurate prediction of a febrile, or afebrile compliant patients oral temperatures after a measurement time (in the sublingual pocket) of only 4 seconds, and axillary temperatures in approximately 10 seconds in the Rapid mode. In Normal mode, the IT2CA1 provides accurate determination of actual, oral and axillary temperatures of compliant patients.

The IT2CA1 is intended for lay or home use only; in a home use environment. It is not intended for use by the clinical professional, such as those utilized in the hospital, clinical, or mobile environment use.

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/K990168 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990168: Microlife IT2CA1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990168

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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