510(k) · Cleared

Cleared

Modification to Thermofocus 0800, 0900, 01500 and 0700 Series

K072108510(k) SpecialCleared Aug 31, 200730-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 Aug 31, 2007 as substantially equivalent to K033790 (Tecnimed S.R.L., 2004) after a 30-day review. Its family tree reaches back 2 generations to 2001. 40 later devices descend from it.

Decided: Aug 31, 2007
Review: 30 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K011291 (2001). 40 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK011291 Temporalscanner Thermometer, SensortouchExergen Corp. · 2001
1 generation backK033790 Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2004
This deviceK072108 Modification to Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2007
Descendant · cites it directly · 20 of its ownK121428 Non-Contact Clinical ThermometerRadiant Innovation, Inc. · 2012
Descendant · cites it directly · 18 of its ownK100953 Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH · 2010
Descendant · 2 generations on · 14 of its ownK162083 RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc. · 2017
Descendant · 2 generations on · 11 of its ownK191829 Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH · 2020
Descendant · 3 generations on · 8 of its ownK191570 Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd. · 2019

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2010high 11 (2021) · low 0 (2011)2026

Most influential descendants

Showing 5 of 40 · See all

K121428Non-Contact Clinical ThermometerRadiant Innovation, Inc. · 2012 · cites it directly20descendants
K100953Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH · 2010 · cites it directly18descendants
K162083RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc. · 2017 · 2 generations on14descendants
K191829Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH · 2020 · 2 generations on11descendants
K191570Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd. · 2019 · 3 generations on8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K011291	Temporalscanner Thermometer, Sensortouch	Exergen Corp.	2001	—
−1	K033790	Thermofocus 0800, 0900, 01500 and 0700 Series	Tecnimed S.R.L.	2004	—
0 (this device)	K072108	Modification to Thermofocus 0800, 0900, 01500 and 0700 Series	Tecnimed S.R.L.	2007	—
+1	K121428	Non-Contact Clinical Thermometer	Radiant Innovation, Inc.	2012	—
+1	K100953	Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1	Microlife Intellectual Property GmbH	2010	—
+2	K162083	RII Multi-function Infrared Thermometer, Model TH52Z	Radiant Innovation, Inc.	2017	—
+2	K191829	Microlife Non-Contact Infrared Forehead Thermometer	Microlife Intellectual Property GmbH	2020	—
+3	K191570	Infrared Thermometer Model MD-H30	Guangzhou Berrcom Medical Device Co., Ltd.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2012	1	0
2015	1	0
2017	1	0
2018	4	0
2019	4	0
2020	3	0
2021	11	0
2022	8	0
2023	3	0
2024	1	0
2025	2	0

FIG. 1 — Lineage of K072108, 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 26.7 · 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
*	K033790	Thermofocus 0800, 0900, 01500 and 0700 Series Summary page 1 …ERMOFOCUS 0800, 0900, 01500 AND 0700 Predicate Device Name and 510(k) Number: SERIES K033790 Description of Device: Thermofocus devices belonging to the 0800, 0900, 01500, 0700 series are hand-h…	Tecnimed S.R.L.	2004	—

Also cleared against K033790: 1 other device →

What descends from it? (40)

See all 40

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

Number	Device	Applicant	Decided	Descendants
K121428	Non-Contact Clinical Thermometer	Radiant Innovation, Inc.	2012	20
K100953	Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1	Microlife Intellectual Property GmbH	2010	18

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 2 companies; a new generation was cleared every 3.2 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K121428 (Radiant Innovation, Inc., 2012) has gone furthest, with 20 descendants of its own.
1 other device also cites its predicate K033790.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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?

Thermofocus 0800, 0900, 01500, 0700 Series are infrared thermometers intended for the

intermittent measurement of human body temperature in people of all ages.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072108 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072108: Modification to Thermofocus 0800, 0900, 01500 and 0700 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072108

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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