510(k) · Cleared
ClearedPallikaris Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories, Inc. · HOG Burr, Corneal, Battery-Powered
Cleared on Mar 11, 1996 after a 53-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Mar 11, 1996
- Review
- 53 days
- Class
- Class I
- Product code
- HOG
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK960261 Pallikaris BrushAlcon Laboratories, Inc. · 1996
- Descendant · cites it directly · 7 of its ownK962989 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K962989Amoils Epithelial ScrubberS. Percy Amoils · 1997 · cites it directly7descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960261 | Pallikaris Brush | Alcon Laboratories, Inc. | 1996 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K962989 (S. Percy Amoils, 1997) has gone furthest, with 7 descendants of its own.
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 | — |
https://510kreport.com/device/K960261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960261: Pallikaris Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960261
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026