510(k) · Cleared
Recalled · Class II · 2025CorNeat EverPatch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corneat Vision, Ltd. · QWU Prosthesis, Eyelid Spacer/Graft, Polymer
Cleared on Jun 2, 2023 as substantially equivalent to K090078 (Iop, Inc., 2009) after a 245-day review. Its family tree reaches back 7 generations to 1992. It has been recalled 3 times.
- Decided
- Jun 2, 2023
- Review
- 245 days
- Class
- Class II
- Product code
- QWU
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 7 generations to K921895 (1992). 20 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 7 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 5 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 4 generations backK034039 Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004
- 3 generations backK050246 Sis Dermal Augmentation StrandCook Biotech, Inc. · 2005
- 2 generations backK053622 Surgisis Ocular GraftIop, Inc. · 2006
- 1 generation backK090078 Kerasys Bioengineered Lamellar Patch GraftIop, Inc. · 2009
- This deviceK223074 CorNeat EverPatchCorneat Vision, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −6 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −5 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −4 | K034039 | Sis Plastic Surgery Matrix | Cook Biotech, Inc. | 2004 | — |
| −3 | K050246 | Sis Dermal Augmentation Strand | Cook Biotech, Inc. | 2005 | — |
| −2 | K053622 | Surgisis Ocular Graft | Iop, Inc. | 2006 | — |
| −1 | K090078 | Kerasys Bioengineered Lamellar Patch Graft | Iop, Inc. | 2009 | — |
| 0 (this device) | K223074 | CorNeat EverPatch | Corneat Vision, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 2 | 0 |
| 1997 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 QWU? 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 |
|---|---|---|---|
| * | K090078 | Kerasys Bioengineered Lamellar Patch GraftSummary page 4…CODE QWU PREDICATE DEVICE: KeraSys Bioengineered Lamellar Patch Graft K090078 (May 8, 2009) REFERENCE DEVICES: Neuro-Patch K960470 (May 10, 1996);… | 2009 |
| † | K960470 | Neuro-Patch | 1996 |
| † | K163001 | PowerFlow Apheresis I.V. Port | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 18, 2025 | Class II | Z-0039-2026 | Unknown/Undetermined by firm | Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. |
| Aug 18, 2025 | Class II | Z-0040-2026 | Unknown/Undetermined by firm | Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. |
| Oct 16, 2024 | Class II | Z-2537-2025 | Unknown/Undetermined by firm | Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 20 ancestors has a recall of any class.
How does its category compare?
All QWU devicesQWU Prosthesis, Eyelid Spacer/Graft, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QWU
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QWU
Too few QWU 510(k)s in any year since 2007 to give a median.
Recalls per year · QWU
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QWU
6in 2025
MAUDE reports naming product code QWU, 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 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 27 |
| 2025 | 0 | — | 2 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CorNeat EverPatch is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223074 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223074: CorNeat EverPatch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223074
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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