510(k) · Cleared
ClearedSurgisis Ocular 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 Mar 15, 2006 as substantially equivalent to K980431 (Cook Biotech, Inc., 1998) and 3 other predicates after a 77-day review. Its family tree reaches back 5 generations to 1992. 2 later devices descend from it.
- Decided
- Mar 15, 2006
- Review
- 77 days
- Class
- Class II
- Product code
- NXM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K921895 (1992). 18 ancestors in all, the oldest K830889 (1983). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 4 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 3 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 2 generations backK034039 Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004
- 1 generation backK050246 Sis Dermal Augmentation StrandCook Biotech, Inc. · 2005
- This deviceK053622 Surgisis Ocular GraftIop, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK090078 Kerasys Bioengineered Lamellar Patch GraftIop, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK223074 CorNeat EverPatchCorneat Vision, Ltd. · 2023 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −4 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −3 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −2 | K034039 | Sis Plastic Surgery Matrix | Cook Biotech, Inc. | 2004 | — |
| −1 | K050246 | Sis Dermal Augmentation Strand | Cook Biotech, Inc. | 2005 | — |
| 0 (this device) | K053622 | Surgisis Ocular Graft | Iop, Inc. | 2006 | — |
| +1 | K090078 | Kerasys Bioengineered Lamellar Patch Graft | Iop, Inc. | 2009 | — |
| +2 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K980431 | SurgisisSummary page 2…SIS Plastic Surgery Matrix Amniotic Membrane SIS Facial Implant 510(k) Applied For K980431 K03210)4 K034039… | 1998 |
| * | K034039 | Sis Plastic Surgery MatrixSummary page 2…SIS Facial Implant 510(k) Applied For K980431 K03210)4 K034039 K050246 Product Specifications Material Processed porcine Processed… | 2004 |
| * | K050246 | Sis Dermal Augmentation StrandSummary page 2…) Applied For K980431 K03210)4 K034039 K050246 Product Specifications Material Processed porcine Processed porcine IAmniotic Membrane with ophthal… | 2005 |
| * | K032104 | Amniolens | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090078 | Kerasys Bioengineered Lamellar Patch Graft | 2009 | 1 |
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 14 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K090078 (Iop, Inc., 2009) has gone furthest, with 1 descendant of its own.
- 28 other devices also cite its predicate K980431.
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.
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 SURGISIS Ocular Graft is intended for implantation to reinforce and aid reconstruction of the eyelid and is labeled for single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053622: Surgisis Ocular Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053622
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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