510(k) · Cleared

Cleared

Oti-Scan 3000

K092837510(k) SpecialCleared Dec 23, 200999-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

Opko Instrumentation, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Dec 23, 2009 as substantially equivalent to K960622 (Ophthalmic Technologies, Inc., 1996) and 2 other predicates after a 99-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.

Decided: Dec 23, 2009
Review: 99 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K960622 (1996). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK960622 I-SCANOphthalmic Technologies, Inc. · 1996
2 generations backK030770 Oti Scan with TransducersOphthalmic Technologies, Inc. · 2003
1 generation backK031391 HF Module with TransducersOphthalmic Technologies, Inc. · 2003
This deviceK092837 Oti-Scan 3000Opko Instrumentation, Inc. · 2009
Descendant · cites it directly · 0 of its ownK103471 Ubm PlusAccutome, Inc. · 2011

Most influential descendants

Showing 1 of 1 · See all

K103471Ubm PlusAccutome, Inc. · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K960622	I-SCAN	Ophthalmic Technologies, Inc.	1996	—
−2	K030770	Oti Scan with Transducers	Ophthalmic Technologies, Inc.	2003	—
−1	K031391	HF Module with Transducers	Ophthalmic Technologies, Inc.	2003	—
0 (this device)	K092837	Oti-Scan 3000	Opko Instrumentation, Inc.	2009	—
+1	K103471	Ubm Plus	Accutome, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K092837, 1996–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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? (3)

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
*	K960622	I-SCAN Summary page 1 …: 892.1560 Class: II Panel: Radiology Product Code: IYO Predicate Devices: OTT I-Scan (K960622) OTT Scan with Transducers (K030770) OTI-Scan HF Module System (K03…	Ophthalmic Technologies, Inc.	1996	—
*	K030770	Oti Scan with Transducers Summary page 1 …Radiology Product Code: IYO Predicate Devices: OTT I-Scan (K960622) OTT Scan with Transducers (K030770) OTI-Scan HF Module System (K03 1391) Device Description: The OTT-Scan 3000 is an Ultra…	Ophthalmic Technologies, Inc.	2003	—
*	K031391	HF Module with Transducers Summary page 1 …te Devices: OTT I-Scan (K960622) OTT Scan with Transducers (K030770) OTI-Scan HF Module System (K03 1391) Device Description: The OTT-Scan 3000 is an Ultrasonic ophthalmic A-Scan and B-Scan sys…	Ophthalmic Technologies, Inc.	2003	—

Also cleared against K960622: 2 other devices →

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
K103471	Ubm Plus	Accutome, Inc.	2011	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 13 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K103471 (Accutome, Inc., 2011) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K960622.

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. 2009, 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?

The OTI-Scan 3000 ultrasound system is a multi-purpose personal-computer based ultrasonic diagnosis system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including measurement of the axial length for determination of IOL power.

Transducer for B-Scans with the OTI-Scan 3000 Ultrasound Imaging System.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K092837 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092837: Oti-Scan 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092837

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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