510(k) · Cleared

Cleared

Oculostat

K981235510(k) TraditionalCleared Jul 15, 1998103-day reviewClass I21 CFR 886.4350

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

Laser Center Dev. Corp. · HNC Specula, Ophthalmic

Cleared on Jul 15, 1998 as substantially equivalent to K964289 (Eyefix, Inc., 1996) after a 103-day review. Its family tree reaches back 2 generations to 1987.

Decided: Jul 15, 1998
Review: 103 days
Class: Class I
Product code: HNC
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K864520 (1987). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK864520 Barron Rotary Blade Trephine Using Hessburg-BarronPrecision Instruments, Inc. · 1987
1 generation backK964289 Eye Fixation SpeculumEyefix, Inc. · 1996
This deviceK981235 OculostatLaser Center Dev. Corp. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K864520	Barron Rotary Blade Trephine Using Hessburg-Barron	Precision Instruments, Inc.	1987	—
−1	K964289	Eye Fixation Speculum	Eyefix, Inc.	1996	—
0 (this device)	K981235	Oculostat	Laser Center Dev. Corp.	1998	—

FIG. 1 — Lineage of K981235, 1987–1998Source: 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 HNC? 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? (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
*	K964289	Eye Fixation Speculum Summary page 1 …stat™ by Laser Center Development Corporation is substantially equivalent to the Eye Fixation Specuium, by eycFix, Inc., which was determined by FDA to be marketable per K964289. DESCRIPTION OF THE DEVICE: The Oculostat by Laser Center Development Corporation consists of a scleral vacuum suction ring att…	Eyefix, Inc.	1996	—

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 11 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All HNC devices

HNC Specula, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HNC

FDA has decided no HNC device since 2007.

Median 510(k) review, days · HNC

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

Recalls per year · HNC

1in 2024

2007high 1 (2024) · low 0 (2007)2026

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

Adverse event reports per year · HNC

1in 2025

2007high 2 (2007) · low 0 (2008)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	2
2008	—	0	0
2009	—	0	0
2010	—	0	1
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	1
2020	—	0	0
2021	—	0	1
2022	—	0	1
2023	—	0	0
2024	—	1	0
2025	—	0	1
2026	—	0	—

What is it indicated for?

Oculostat is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K981235 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981235: Oculostat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981235

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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