510(k) · Cleared

Cleared

ArcScan Insight 100

K153416510(k) SpecialCleared Feb 2, 201669-day reviewClass II21 CFR 892.1560

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

Arcscan, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Feb 2, 2016 as substantially equivalent to K021333 (Ultralink, LLC, 2002) after a 69-day review. Its family tree reaches back 2 generations to 2001.

Decided: Feb 2, 2016
Review: 69 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K003890 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK003890 VHF Ultrasonic Arc-Scan SystemUltralink, LLC · 2001
1 generation backK021333 ArtemisUltralink, LLC · 2002
This deviceK153416 ArcScan Insight 100Arcscan, Inc. · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003890	VHF Ultrasonic Arc-Scan System	Ultralink, LLC	2001	—
−1	K021333	Artemis	Ultralink, LLC	2002	—
0 (this device)	K153416	ArcScan Insight 100	Arcscan, Inc.	2016	—

FIG. 1 — Lineage of K153416, 2001–2016Source: 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 IYO? 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 IYO device

#1 K243937 Accuro 3Sscore 20.5 · 18 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
*	K021333	Artemis Summary page 5 …e names Artemis VHF Ultrasonic Arcscan System (Artemis 2) 510(k) number K021333 DEVICE DESCRIPTION ArcScan Insight 100 is a precision ultrasound device for imaging and biometry of the eye. It uses a 20-60 MHz…	Ultralink, LLC	2002	—

Also cleared against K021333: 1 other device →

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?

The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 13.3 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K021333.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · IYO

7in 2025

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

2007high 11 (2021) · low 0 (2011)2026

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

Adverse event reports per year · IYO

485in 2025

2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, 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	20	17	4	39
2008	14	36	5	20
2009	13	79	9	27
2010	15	113	8	20
2011	11	69	0	58
2012	15	68	2	78
2013	17	50	3	436
2014	14	63	2	304
2015	19	46	1	268
2016	10	36	0	254
2017	19	72	0	238
2018	14	56	1	368
2019	13	59	1	537
2020	11	57	0	498
2021	15	64	11	617
2022	5	190	1	511
2023	11	177	0	527
2024	10	220	0	640
2025	7	171	0	485
2026	10	139	1	—

What is it indicated for?

Read the full statement (113 words)

The ArcScan Insight 100 is indicated for use in adults to measure dimensions of components of the human eye. To provide tomographic, high-resolution ultrasound images of the anterior portion of the eye. It is also designed to measure these tissues and structures, such as anterior chamber depth, angle-to-angle width and sulcus-to-sulcus width. Measurements can be made of the cornea and its individual layers including the epithelium, stroma, and surgically induced surfaces. Measurement also may be made of pathological structures such as solid masses or cysts and it is therefore useful in evaluation and/or planning of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, glaucoma and hypotony.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K153416 · printed Nov 6, 2026

Cite this page

510(k) Report. “K153416: ArcScan Insight 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153416

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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