510(k) · Cleared

Cleared

Centurion Ses Epikeratome

K042810510(k) SpecialCleared Oct 28, 200416-day reviewClass I21 CFR 886.4370

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

Norwood Abbey, Ltd. · HNO Keratome, Ac-Powered

Cleared on Oct 28, 2004 as substantially equivalent to K032978 (Ciba Vision Corporation, 2003) after a 16-day review. Its family tree reaches back 4 generations to 1996.

Decided: Oct 28, 2004
Review: 16 days
Class: Class I
Product code: HNO
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K960261 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK960261 Pallikaris BrushAlcon Laboratories, Inc. · 1996
3 generations backK962989 Amoils Epithelial ScrubberS. Percy Amoils · 1997
2 generations backK031735 Centurion Ses EpikeratomeCiba Vision Corporation · 2003
1 generation backK032978 Modification to Ciba Vision Centurion Ses SpikeratomeCiba Vision Corporation · 2003
This deviceK042810 Centurion Ses EpikeratomeNorwood Abbey, Ltd. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K960261	Pallikaris Brush	Alcon Laboratories, Inc.	1996	—
−3	K962989	Amoils Epithelial Scrubber	S. Percy Amoils	1997	—
−2	K031735	Centurion Ses Epikeratome	Ciba Vision Corporation	2003	—
−1	K032978	Modification to Ciba Vision Centurion Ses Spikeratome	Ciba Vision Corporation	2003	—
0 (this device)	K042810	Centurion Ses Epikeratome	Norwood Abbey, Ltd.	2004	—

FIG. 1 — Lineage of K042810, 1996–2004Source: 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 HNO? 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
*	K032978	Modification to Ciba Vision Centurion Ses Spikeratome Summary page 1 …turion SES Epikeratome 9.0mm suction ring is substantially equivalent to the CIBA Vision (now Norwood Abbey) Centurion SES Epikeratome 10.0 mm suction ring cleared under K032978. Both the 9.0mm and 10.0mm Suction Ring for the Centurion SESTM Epikeratome has the same intended use and basic scientific techno…	Ciba Vision Corporation	2003	—

Also cleared against K032978: 2 other devices →

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 8 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
None of the 4 ancestors has a recall.
2 other devices also cite its predicate K032978.

How does its category compare?

All HNO devices

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

FDA decisions per year · HNO

1in 2018

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HNO

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

Recalls per year · HNO

4in 2011

2007high 4 (2011) · low 0 (2009)2026

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

Adverse event reports per year · HNO

7in 2024

2007high 2,265 (2018) · low 0 (2025)2025

MAUDE reports naming product code HNO, 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	0	—	2	32
2008	1	—	2	31
2009	1	—	0	85
2010	0	—	0	84
2011	0	—	4	90
2012	0	—	0	100
2013	0	—	0	353
2014	0	—	0	452
2015	0	—	0	966
2016	0	—	0	1,397
2017	1	—	0	2,112
2018	1	—	0	2,265
2019	0	—	0	816
2020	0	—	0	405
2021	0	—	0	72
2022	0	—	0	7
2023	0	—	0	10
2024	0	—	0	7
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The Norwood Abbey Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea, and for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042810 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042810: Centurion Ses Epikeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042810

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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