510(k) · Cleared
ClearedKerasys Bioengineered Lamellar Patch Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iop, Inc. · NXM Prosthesis, Eyelid Spacer/Graft, Biologic
Cleared on May 8, 2009 as substantially equivalent to K053622 (Iop, Inc., 2006) and 1 other predicate after a 116-day review. Its family tree reaches back 6 generations to 1992. 1 later device descends from it.
- Decided
- May 8, 2009
- Review
- 116 days
- Class
- Class II
- Product code
- NXM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K921895 (1992). 19 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 4 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 3 generations backK034039 Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004
- 2 generations backK050246 Sis Dermal Augmentation StrandCook Biotech, Inc. · 2005
- 1 generation backK053622 Surgisis Ocular GraftIop, Inc. · 2006
- This deviceK090078 Kerasys Bioengineered Lamellar Patch GraftIop, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK223074 CorNeat EverPatchCorneat Vision, Ltd. · 2023 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K223074CorNeat EverPatchCorneat Vision, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −5 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −4 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −3 | K034039 | Sis Plastic Surgery Matrix | Cook Biotech, Inc. | 2004 | — |
| −2 | K050246 | Sis Dermal Augmentation Strand | Cook Biotech, Inc. | 2005 | — |
| −1 | K053622 | Surgisis Ocular Graft | Iop, Inc. | 2006 | — |
| 0 (this device) | K090078 | Kerasys Bioengineered Lamellar Patch Graft | Iop, Inc. | 2009 | — |
| +1 | K223074 | CorNeat EverPatch | Corneat Vision, Ltd. | 2023 | 3 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 NXM? 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? (2)
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 |
|---|---|---|---|
| * | K053622 | Surgisis Ocular GraftSummary page 2…Bioengineered Patch Name(s) tarSys Bioengineered Eyelid Graft lx1.5cm -prosthesis 510(k) K053622 K050246 Applied for 510(k) K090078 I… | 2006 |
| * | K050246 | Sis Dermal Augmentation StrandSummary page 2…tarSys Bioengineered Eyelid Graft lx1.5cm -prosthesis 510(k) K053622 K050246 Applied for 510(k) K090078 I 11… | 2005 |
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 |
|---|---|---|---|
| K223074 | CorNeat EverPatch | 2023 | 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 17 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K223074 (Corneat Vision, Ltd., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NXM devicesNXM Prosthesis, Eyelid Spacer/Graft, Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · NXM
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · NXM
Too few NXM 510(k)s in any year since 2007 to give a median.
Recalls per year · NXM
No recall names NXM since 2007.
Adverse event reports per year · NXM
1in 2015
MAUDE reports naming product code NXM, 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 | 1 | — | 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 | 1 |
| 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 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KaraSys Bioengineered Lamellar Patch Graft is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface. KaraSys is labeled for single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090078 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090078: Kerasys Bioengineered Lamellar Patch Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090078
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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