510(k) · Cleared
ClearedEPI-K
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moria SA · HNO Keratome, Ac-Powered
Cleared on Mar 25, 2005 as substantially equivalent to K040297 (Moria SA, 2004) and 2 other predicates after a 128-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Mar 25, 2005
- Review
- 128 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K960261 (1996). 15 ancestors in all, the oldest K860001 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK960261 Pallikaris BrushAlcon Laboratories, Inc. · 1996
- 4 generations backK962989 Amoils Epithelial ScrubberS. Percy Amoils · 1997
- 3 generations backK031735 Centurion Ses EpikeratomeCiba Vision Corporation · 2003
- 2 generations backK032978 Modification to Ciba Vision Centurion Ses SpikeratomeCiba Vision Corporation · 2003
- 1 generation backK041206 Epitome SystemGebauer Medizintechnik GmbH · 2004
- This deviceK043183 EPI-KMoria SA · 2005
- Descendant · cites it directly · 0 of its ownK172994 EPI K ConsoleMoria SA · 2017
Most influential descendants
Showing 1 of 1 · See all- K172994EPI K ConsoleMoria SA · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960261 | Pallikaris Brush | Alcon Laboratories, Inc. | 1996 | — |
| −4 | K962989 | Amoils Epithelial Scrubber | S. Percy Amoils | 1997 | — |
| −3 | K031735 | Centurion Ses Epikeratome | Ciba Vision Corporation | 2003 | — |
| −2 | K032978 | Modification to Ciba Vision Centurion Ses Spikeratome | Ciba Vision Corporation | 2003 | — |
| −1 | K041206 | Epitome System | Gebauer Medizintechnik GmbH | 2004 | — |
| 0 (this device) | K043183 | EPI-K | Moria SA | 2005 | — |
| +1 | K172994 | EPI K Console | Moria SA | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K040297 | Oneuse- Plus MicrokeratomeSummary page 1…devices: Trade or Proprietary or Model Name: OneUse - Plus Microkeratome Manufacturer: MORIA S.A. 510(k) number: K040297 Trade or Proprietary or Model Name: Centurion SESTM Epikeratome Manufacturer: CIBA Vision Corporation 510(k) number… | 2004 |
| * | K032978 | Modification to Ciba Vision Centurion Ses SpikeratomeSummary page 1…. 510(k) number: K040297 Trade or Proprietary or Model Name: Centurion SESTM Epikeratome Manufacturer: CIBA Vision Corporation 510(k) number: K032978 15 RUEGEORGES BESSE F 92160 ANTONY ~ 01 46 74 46 74 f… | 2003 |
| * | K041206 | Epitome SystemSummary page 2…TM Section 4 page 2 Trade or Proprietary or Model Name: EpiTome SYSTEM Manufacturer: GEBAUER MEDZINTECIINIK GmbH 510(k) number: K041206 5. Submitted device description List of components * Power unit and footswitch * }landpiece / submitted device motor * [le… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172994 | EPI K Console | 2017 | 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 9 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K172994 (Moria SA, 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HNO devicesHNO Keratome, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HNO
1in 2018
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HNO
7in 2024
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 Epi-K TM is intended for use in the separation of the epithelium from the cornea in
preparation for subsequent surgical procedures on denuded cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043183 · printed Nov 3, 2026
Cite this page
510(k) Report. “K043183: EPI-K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043183
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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