510(k) · Cleared

Cleared

IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU)

K152402510(k) TraditionalCleared Mar 4, 2016192-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

Securus,Inc · FLL Continuous Measurement Thermometer

Cleared on Mar 4, 2016 as substantially equivalent to K123361 (Fiab Spa, 2013) after a 192-day review. Its family tree reaches back 3 generations to 1986. 1 later device descends from it.

Decided: Mar 4, 2016
Review: 192 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K863646 (1986). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK863646 Esophageal Rectal Temperature ProbeRespiratory Support Products, Inc. · 1986
2 generations backK112376 S-Cath Esophageal Temperature Probe and Temperature Monitoring SystemCirca Scientific, LLC · 2011
1 generation backK123361 Esotest Esophageal Temperature Probe and Temperature Monitoring SystemFiab Spa · 2013
This deviceK152402 IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit…Securus,Inc · 2016
Descendant · cites it directly · 0 of its ownK180148 ATS Thermal Imaging Probe, ATS Patient Interface UnitSecurus Medical Group, Inc. · 2018

Most influential descendants

Showing 1 of 1 · See all

K180148ATS Thermal Imaging Probe, ATS Patient Interface UnitSecurus Medical Group, Inc. · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K863646	Esophageal Rectal Temperature Probe	Respiratory Support Products, Inc.	1986	—
−2	K112376	S-Cath Esophageal Temperature Probe and Temperature Monitoring System	Circa Scientific, LLC	2011	—
−1	K123361	Esotest Esophageal Temperature Probe and Temperature Monitoring System	Fiab Spa	2013	—
0 (this device)	K152402	IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS…	Securus,Inc	2016	—
+1	K180148	ATS Thermal Imaging Probe, ATS Patient Interface Unit	Securus Medical Group, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K152402, 1986–2018Source: 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

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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
*	K123361	Esotest Esophageal Temperature Probe and Temperature Monitoring System Summary page 4 …] Submissions for Clinical Electronic Thermometers, March 1993 3) Predicate Device ESOTEST Esophageal Temperature Probe and Temperature Monitoring System, FIAB, (K123361) 4) Reference Device S-Cath Esophageal Temperature Probe and Temperature Monitoring System, Circa Scientific, (K112376)…	Fiab Spa	2013	—
†	K112376	S-Cath Esophageal Temperature Probe and Temperature Monitoring System	Circa Scientific, LLC	2011	—

Also cleared against K123361: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K180148	ATS Thermal Imaging Probe, ATS Patient Interface Unit	Securus Medical Group, Inc.	2018	0

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 30 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K180148 (Securus Medical Group, Inc., 2018) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K123361.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?

The IRTS Probe is intended for continuous esophageal temperature monitoring.

The IRTS Patient Monitoring Unit (PMU) with Patient Interface Unit (PIU) is intended to display continuous temperature measurements (C°) from the IRTS Thermal Imaging Probe.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K152402 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152402: IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152402

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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