510(k) · Decided

Decided

Opd-Scan, Models Ark-10000 and Ark-9000

K003299510(k) TraditionalDecided Mar 9, 2001140-day reviewClass I21 CFR 886.1350

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

Nidek Co., Ltd. · HLQ Keratoscope, Ac-Powered

Cleared on Mar 9, 2001 after a 140-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Mar 9, 2001
Review: 140 days
Class: Class I
Product code: HLQ
Recalls: None
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK003299 Opd-Scan, Models Ark-10000 and Ark-9000Nidek Co., Ltd. · 2001
Descendant · cites it directly · 0 of its ownK133062 Discovery SystemInnovative Visual Systems · 2014
Descendant · cites it directly · 0 of its ownK050336 Opd-Station SoftwareNidek, Inc. · 2005

Most influential descendants

Showing 2 of 2 · See all

K133062Discovery SystemInnovative Visual Systems · 2014 · cites it directly0descendants
K050336Opd-Station SoftwareNidek, Inc. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003299	Opd-Scan, Models Ark-10000 and Ark-9000	Nidek Co., Ltd.	2001	—
+1	K133062	Discovery System	Innovative Visual Systems	2014	—
+1	K050336	Opd-Station Software	Nidek, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2014	1	0

FIG. 1 — Lineage of K003299, 2001–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HLQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K133062	Discovery System	Innovative Visual Systems	2014	0
K050336	Opd-Station Software	Nidek, Inc.	2005	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?

Of its descendants, K133062 (Innovative Visual Systems, 2014) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HLQ devices

HLQ Keratoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HLQ

FDA has decided no HLQ device since 2007.

Median 510(k) review, days · HLQ

Too few HLQ 510(k)s in any year since 2007 to give a median.

Recalls per year · HLQ

No recall names HLQ since 2007.

Adverse event reports per year · HLQ

1in 2017

2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code HLQ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K003299 · printed Nov 3, 2026

Cite this page

510(k) Report. “K003299: Opd-Scan, Models Ark-10000 and Ark-9000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K003299

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026