510(k) · Cleared
ClearedAmoils Epithelial Scrubber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
S. Percy Amoils · HOG Burr, Corneal, Battery-Powered
Cleared on Jan 9, 1997 as substantially equivalent to K960261 (Alcon Laboratories, Inc., 1996) after a 161-day review. Its family tree reaches back 1 generation to 1996. 7 later devices descend from it.
- Decided
- Jan 9, 1997
- Review
- 161 days
- Class
- Class I
- Product code
- HOG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960261 (1996). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK960261 Pallikaris BrushAlcon Laboratories, Inc. · 1996
- This deviceK962989 Amoils Epithelial ScrubberS. Percy Amoils · 1997
- Descendant · cites it directly · 6 of its ownK031735 Centurion Ses EpikeratomeCiba Vision Corporation · 2003
- Descendant · 2 generations on · 5 of its ownK032978 Modification to Ciba Vision Centurion Ses SpikeratomeCiba Vision Corporation · 2003
- Descendant · 3 generations on · 3 of its ownK041206 Epitome SystemGebauer Medizintechnik GmbH · 2004
- Descendant · 3 generations on · 1 of its ownK043183 EPI-KMoria SA · 2005
- Descendant · 4 generations on · 0 of its ownK172994 EPI K ConsoleMoria SA · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K031735Centurion Ses EpikeratomeCiba Vision Corporation · 2003 · cites it directly6descendants
- K032978Modification to Ciba Vision Centurion Ses SpikeratomeCiba Vision Corporation · 2003 · 2 generations on5descendants
- K041206Epitome SystemGebauer Medizintechnik GmbH · 2004 · 3 generations on3descendants
- K043183EPI-KMoria SA · 2005 · 3 generations on1descendant
- K172994EPI K ConsoleMoria SA · 2017 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960261 | Pallikaris Brush | Alcon Laboratories, Inc. | 1996 | — |
| 0 (this device) | K962989 | Amoils Epithelial Scrubber | S. Percy Amoils | 1997 | — |
| +1 | K031735 | Centurion Ses Epikeratome | Ciba Vision Corporation | 2003 | — |
| +2 | K032978 | Modification to Ciba Vision Centurion Ses Spikeratome | Ciba Vision Corporation | 2003 | — |
| +3 | K041206 | Epitome System | Gebauer Medizintechnik GmbH | 2004 | — |
| +3 | K043183 | EPI-K | Moria SA | 2005 | — |
| +4 | K172994 | EPI K Console | Moria SA | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 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 HOG? 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 |
|---|---|---|---|
| * | K960261 | Pallikaris BrushSummary page 1…Class I, 21 CFR §886.4070 Panel: 86 Ophthalmic Procode: HOG (Burr, Corneal) 3. Identification of Predicate Device(s) The Pallikaris Automated Epithelial Removal Brush, K960261 4. Description of the Device The Amoils Epithelial Scrubber ("epithelial scrubber") is a small, powered hand- held device to whi… | 1996 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031735 | Centurion Ses Epikeratome | 2003 | 6 |
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?
How does its category compare?
All HOG devicesHOG Burr, Corneal, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HOG
FDA has decided no HOG device since 2007.
Median 510(k) review, days · HOG
Too few HOG 510(k)s in any year since 2007 to give a median.
Recalls per year · HOG
No recall names HOG since 2007.
Adverse event reports per year · HOG
1in 2021
MAUDE reports naming product code HOG, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The epithelial scrubber is intended for deepithelialization of the cornea in preparation for subsequent surgical procedures on the denuded cornea.
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/K962989 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962989: Amoils Epithelial Scrubber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962989
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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