510(k) · Cleared

Cleared

Automated Corneal Trephine

K981063510(k) TraditionalCleared Jun 23, 199892-day reviewClass I21 CFR 886.4070

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. · HRG Engine, Trephine, Accessories, Ac-Powered

Cleared on Jun 23, 1998 as substantially equivalent to K864520 (Precision Instruments, Inc., 1987) after a 92-day review. Its family tree reaches back 1 generation to 1987. 61 later devices descend from it.

Decided: Jun 23, 1998
Review: 92 days
Class: Class I
Product code: HRG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K864520 (1987). 61 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK864520 Barron Rotary Blade Trephine Using Hessburg-BarronPrecision Instruments, Inc. · 1987
This deviceK981063 Automated Corneal TrephineLaser Center Dev. Corp. · 1998
Descendant · cites it directly · 60 of its ownK041893 Intralase FS LaserIntra Lase Corp. · 2005
Descendant · 2 generations on · 58 of its ownK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
Descendant · 3 generations on · 57 of its ownK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
Descendant · 3 generations on · 56 of its ownK073404 Ifs Laser SystemIntra Lase Corp. · 2008
Descendant · 2 generations on · 51 of its ownK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

2005high 8 (2012) · low 0 (2024)2026

Most influential descendants

Showing 5 of 61 · See all

K041893Intralase FS LaserIntra Lase Corp. · 2005 · cites it directly60descendants
K060372Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006 · 2 generations on58descendants
K063682Intralase Fusion LaserIntra Lase Corp. · 2007 · 3 generations on57descendants
K073404Ifs Laser SystemIntra Lase Corp. · 2008 · 3 generations on56descendants
K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 2 generations on51descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K864520	Barron Rotary Blade Trephine Using Hessburg-Barron	Precision Instruments, Inc.	1987	—
0 (this device)	K981063	Automated Corneal Trephine	Laser Center Dev. Corp.	1998	—
+1	K041893	Intralase FS Laser	Intra Lase Corp.	2005	—
+2	K060372	Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3	Intra Lase Corp.	2006	—
+3	K063682	Intralase Fusion Laser	Intra Lase Corp.	2007	—
+3	K073404	Ifs Laser System	Intra Lase Corp.	2008	—
+2	K082947	Lensx 550 Laser System	Lensx Lasers, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2007	1	0
2008	2	0
2009	2	0
2010	5	0
2011	4	0
2012	8	0
2013	2	0
2014	4	0
2015	6	0
2016	2	0
2017	6	0
2018	6	0
2019	1	0
2020	2	0
2021	1	0
2022	3	0
2023	2	0
2025	2	0

FIG. 1 — Lineage of K981063, 1987–2025Source: 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 HRG? 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
*	K864520	Barron Rotary Blade Trephine Using Hessburg-Barron Summary page 1 …TIALLY EQUIVALENT TO: The Automated Comeal Trephine, by I.aser Center Development Corporation, is substantially equivalent to the Barron-Hessburg manual comeal trephine (K864520). DESCRIPTION OF THE DEVICE: 'The Automated Corneal Trephine consists of a sterile, single use, disposable corneal trephine made…	Precision Instruments, Inc.	1987	—

Also cleared against K864520: 2 other devices →

What descends from it? (61)

See all 61

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

Number	Device	Applicant	Decided	Descendants
K041893	Intralase FS Laser	Intra Lase Corp.	2005	60
K092647	Lensx 550 Laser System	Lensx Lasers, Inc.	2009	31

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.
Of its descendants, K041893 (Intra Lase Corp., 2005) has gone furthest, with 60 descendants of its own.
2 other devices also cite its predicate K864520.

How does its category compare?

All HRG devices

HRG Engine, Trephine, Accessories, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRG

FDA has decided no HRG device since 2007.

Median 510(k) review, days · HRG

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

Recalls per year · HRG

No recall names HRG since 2007.

Adverse event reports per year · HRG

1in 2025

2007high 1 (2025) · low 0 (2007)2025

MAUDE reports naming product code HRG, 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	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	1
2026	—	—

What is it indicated for?

Lamellar keratoplasty

Penetrating Keratoplasty

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/K981063 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981063: Automated Corneal Trephine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981063

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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