510(k) · Cleared

Cleared

ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer

K152905510(k) TraditionalCleared Jul 20, 2016293-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

Arc Devices Limited · FLL Continuous Measurement Thermometer

Cleared on Jul 20, 2016 as substantially equivalent to K090361 (Rycom Electron Technology Limited, 2009) after a 293-day review. Its family tree reaches back 1 generation to 2009.

Decided: Jul 20, 2016
Review: 293 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K090361 (2009). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK090361 Remote Infrared Thermometer, Model RC002Rycom Electron Technology Limited · 2009
This deviceK152905 ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch…Arc Devices Limited · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K090361	Remote Infrared Thermometer, Model RC002	Rycom Electron Technology Limited	2009	—
0 (this device)	K152905	ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer	Arc Devices Limited	2016	—

FIG. 1 — Lineage of K152905, 2009–2016Source: 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
*	K090361	Remote Infrared Thermometer, Model RC002 Summary page 5 …cal Electronic Thermometer) Regulatory Class: Class II Product Code: FLL III. PREDICATE DEVICE Rycom Electron Technology Limited, RC002 Remote Infrared Thermometer, K090361, cleared 16th June 2010. IV. DEVICE DESCRIPTION The ARC Non-Touch Thermometer is a fast, accurate and non-intrusive device fo…	Rycom Electron Technology Limited	2009	—

Also cleared against K090361: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
2 other devices also cite its predicate K090361.

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 ARC InstaTemp™ is an infrared thermometer that measures temperature from the forehead in both infants and adults without contacting the human body.

The ARC InstaTemp MD™ is an infrared thermometer that measures temperature from the forehead in both infants and adults without contacting the human body. It is intended for use by a Health Care Professional in a clinical environment. This device is not intended for home use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K152905 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152905: ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152905

Report an extraction error

Are you the manufacturer?

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