510(k) · Cleared
ClearedEPI K Console
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 Oct 26, 2017 as substantially equivalent to K043183 (Moria SA, 2005) after a 29-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Oct 26, 2017
- Review
- 29 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K960261 (1996). 16 ancestors in all, the oldest K860001 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK960261 Pallikaris BrushAlcon Laboratories, Inc. · 1996
- 5 generations backK962989 Amoils Epithelial ScrubberS. Percy Amoils · 1997
- 4 generations backK031735 Centurion Ses EpikeratomeCiba Vision Corporation · 2003
- 3 generations backK032978 Modification to Ciba Vision Centurion Ses SpikeratomeCiba Vision Corporation · 2003
- 2 generations backK041206 Epitome SystemGebauer Medizintechnik GmbH · 2004
- 1 generation backK043183 EPI-KMoria SA · 2005
- This deviceK172994 EPI K ConsoleMoria SA · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960261 | Pallikaris Brush | Alcon Laboratories, Inc. | 1996 | — |
| −5 | K962989 | Amoils Epithelial Scrubber | S. Percy Amoils | 1997 | — |
| −4 | K031735 | Centurion Ses Epikeratome | Ciba Vision Corporation | 2003 | — |
| −3 | K032978 | Modification to Ciba Vision Centurion Ses Spikeratome | Ciba Vision Corporation | 2003 | — |
| −2 | K041206 | Epitome System | Gebauer Medizintechnik GmbH | 2004 | — |
| −1 | K043183 | EPI-K | Moria SA | 2005 | — |
| 0 (this device) | 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 |
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? (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 | Decided |
|---|---|---|---|
| * | K043183 | EPI-KSummary page 4…3E Console Common Name: Keratome power unit Regulatory Class: I Regulation: 886.4370 keratome, AC powered Product Codes: HNO Predicate Device: K043183 Epi-K Device Description : The Evolution 3E Console includes pumps for producing vacuum for use with a keratome in the separation… | 2005 |
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 21 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- None of the 16 ancestors has a recall.
How does its category compare?
All HNO devicesHNO Keratome, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 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/K172994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172994: EPI K Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172994
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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