510(k) · Cleared
ClearedOcu-Guard and Ocu-Guard Supple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Vascular, Inc. · HQX Implant, Orbital, Extra-Ocular
Cleared on Nov 6, 1998 as substantially equivalent to K973552 (Bio-Vascular, Inc., 1997) after a 24-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Nov 6, 1998
- Review
- 24 days
- Class
- Class II
- Product code
- HQX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K842066 (1985). 9 ancestors in all, the oldest K821532 (1982). No later device cites it as a predicate yet.
- Root · 3 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 2 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 1 generation backK973552 Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapBio-Vascular, Inc. · 1997
- This deviceK983581 Ocu-Guard and Ocu-Guard SuppleBio-Vascular, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −2 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −1 | K973552 | Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap | Bio-Vascular, Inc. | 1997 | — |
| 0 (this device) | K983581 | Ocu-Guard and Ocu-Guard Supple | Bio-Vascular, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 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 HQX? 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 |
|---|---|---|---|
| * | K973552 | Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapSummary page 1…Common or Usual Name: Ocu-Guard Supple™ Orbital Implant Wrap (Flat & Preformed) Device Classification Name: Eye sphere implant Substantial Equivalence: Ocu-Guard Supple K973552 Device Description: Ocu-Guard Supple is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Statement o… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All HQX devicesHQX Implant, Orbital, Extra-Ocular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQX
FDA has decided no HQX device since 2007.
Median 510(k) review, days · HQX
Too few HQX 510(k)s in any year since 2007 to give a median.
Recalls per year · HQX
No recall names HQX since 2007.
Adverse event reports per year · HQX
2in 2022
MAUDE reports naming product code HQX, 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 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Ocu-Guard Supple is indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the implant. Ocu-Guard Supple allows for tissue ingrowth through the vascularization process and protects the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard Supple also allows for muscle reattachment to facilitate motility of the implant.
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/K983581 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983581: Ocu-Guard and Ocu-Guard Supple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983581
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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