510(k) · Cleared

Cleared

Thermofocus 0800, 0900, 01500 and 0700 Series

K033790510(k) TraditionalCleared Jun 3, 2004182-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

Tecnimed S.R.L. · FLL Continuous Measurement Thermometer

Cleared on Jun 3, 2004 as substantially equivalent to K011291 (Exergen Corp., 2001) after a 182-day review. Its family tree reaches back 1 generation to 2001. 80 later devices descend from it.

Decided: Jun 3, 2004
Review: 182 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011291 (2001). 80 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK011291 Temporalscanner Thermometer, SensortouchExergen Corp. · 2001
This deviceK033790 Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2004
Descendant · cites it directly · 40 of its ownK072108 Modification to Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2007
Descendant · cites it directly · 38 of its ownK081160 Avita Radar Thermo IR Thermometer, NT1 SeriesAvita Corporation · 2008
Descendant · 2 generations on · 36 of its ownK134043 NO Touch+Forehead NTF 3000 ThermometerKaz USA, Inc (A Subsidiaryof Kaz Inc) · 2014
Descendant · 2 generations on · 20 of its ownK121428 Non-Contact Clinical ThermometerRadiant Innovation, Inc. · 2012
Descendant · 2 generations on · 18 of its ownK100953 Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH · 2010

Showing 5 of 80 descendants. See all descendants

Descendants cleared per year

2007high 19 (2021) · low 0 (2011)2026

Most influential descendants

Showing 5 of 80 · See all

K072108Modification to Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2007 · cites it directly40descendants
K081160Avita Radar Thermo IR Thermometer, NT1 SeriesAvita Corporation · 2008 · cites it directly38descendants
K134043NO Touch+Forehead NTF 3000 ThermometerKaz USA, Inc (A Subsidiaryof Kaz Inc) · 2014 · 2 generations on36descendants
K121428Non-Contact Clinical ThermometerRadiant Innovation, Inc. · 2012 · 2 generations on20descendants
K100953Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH · 2010 · 2 generations on18descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011291	Temporalscanner Thermometer, Sensortouch	Exergen Corp.	2001	—
0 (this device)	K033790	Thermofocus 0800, 0900, 01500 and 0700 Series	Tecnimed S.R.L.	2004	—
+1	K072108	Modification to Thermofocus 0800, 0900, 01500 and 0700 Series	Tecnimed S.R.L.	2007	—
+1	K081160	Avita Radar Thermo IR Thermometer, NT1 Series	Avita Corporation	2008	—
+2	K134043	NO Touch+Forehead NTF 3000 Thermometer	Kaz USA, Inc (A Subsidiaryof Kaz Inc)	2014	—
+2	K121428	Non-Contact Clinical Thermometer	Radiant Innovation, Inc.	2012	—
+2	K100953	Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1	Microlife Intellectual Property GmbH	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	1	0
2010	1	0
2012	1	0
2014	1	0
2015	1	0
2016	2	0
2017	4	0
2018	7	0
2019	9	0
2020	10	0
2021	19	0
2022	12	0
2023	5	0
2024	1	0
2025	4	0

FIG. 1 — Lineage of K033790, 2001–2025Source: 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 26.8 · 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
*	K011291	Temporalscanner Thermometer, Sensortouch Summary page 1 …Predicate Device: TemporalScanner thermometer, formerly known as SensorTouch (K011291) made by Exergen Corporation - Watertown - MA…	Exergen Corp.	2001	—

Also cleared against K011291: 16 other devices →

What descends from it? (80)

See all 80

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K072108	Modification to Thermofocus 0800, 0900, 01500 and 0700 Series	Tecnimed S.R.L.	2007	40
K081160	Avita Radar Thermo IR Thermometer, NT1 Series	Avita Corporation	2008	38

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, K072108 (Tecnimed S.R.L., 2007) has gone furthest, with 40 descendants of its own.
16 other devices also cite its predicate K011291.

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 Thermofocus series 0800, 0900, 01500 and 0700 are infrared thermometers intended for the intermittent measurement of human body temperature of people of all ages

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033790 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033790: Thermofocus 0800, 0900, 01500 and 0700 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033790

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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