510(k) Report

510(k) · Cleared

Cleared

Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap

K973552510(k) TraditionalCleared Dec 16, 199788-day reviewClass II21 CFR 886.3320

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bio-Vascular, Inc. · MTZ Wrap, Implant, Orbital

Cleared on Dec 16, 1997 as substantially equivalent to K934834 (Oculo Plastik, Inc., 1994) and 7 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it.

Decided
Dec 16, 1997
Review
88 days
Class
Class II
Product code
MTZ
Recalls
None
Predicates
8

Its longest line of descent runs back 2 generations to K842066 (1985). 8 ancestors in all, the oldest K821532 (1982). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1994: 1 other ancestor1992: 2 other ancestors1983: 1 other ancestor1982: 1 other ancestor1998: 1 descendant clearedK842066 · Peri-Guard Pericardial Patch · Genetic Laboratories, Inc. · 1985K961811 · Peri-Guard Pericardium · Bio-Vascular, Inc. · 199619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors 1 generation forward: 1 descendant K961811 · Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K842066 · Peri-Guard Pericardial Patch · Genetic Laboratories, Inc. · 19850
  1. Root · 2 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
  2. 1 generation backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. This deviceK973552 Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapBio-Vascular, Inc. · 1997
  4. Descendant · cites it directly · 0 of its ownK983581 Ocu-Guard and Ocu-Guard SuppleBio-Vascular, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K983581Ocu-Guard and Ocu-Guard SuppleBio-Vascular, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K842066Peri-Guard Pericardial PatchGenetic Laboratories, Inc.1985—
−1K961811Peri-Guard PericardiumBio-Vascular, Inc.1996—
0 (this device)K973552Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapBio-Vascular, Inc.1997—
+1K983581Ocu-Guard and Ocu-Guard SuppleBio-Vascular, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198310
199220
199410
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K973552, 1985–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MTZ? 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
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What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K934834Eptfe Sheet Covering for Ocular Implant
Summary page 1
…nt, Eye Sphere (Accessory) Device Classification Name: Implant, Eye Sphere (Accessory) Substantial Equivalence: Oculo-Plastik ePTFE Sheet Covering for Ocular Implant (K934834) Peri-Guard (K821532, K833021, K842066 and K961811) Supple Peri-Guard (K921895, K923657 and K961810) Device Description: Ocu-Gu…
Oculo Plastik, Inc.1994—
*K821532Periguard Pericardial Patch
Summary page 1
…sory) Device Classification Name: Implant, Eye Sphere (Accessory) Substantial Equivalence: Oculo-Plastik ePTFE Sheet Covering for Ocular Implant (K934834) Peri-Guard (K821532, K833021, K842066 and K961811) Supple Peri-Guard (K921895, K923657 and K961810) Device Description: Ocu-Guard™ Orbital Implant…
Genetic Laboratories, Inc.1982—
*K833021Peri-Guard Pericardial Patch-Hernia
Summary page 1
…vice Classification Name: Implant, Eye Sphere (Accessory) Substantial Equivalence: Oculo-Plastik ePTFE Sheet Covering for Ocular Implant (K934834) Peri-Guard (K821532, K833021, K842066 and K961811) Supple Peri-Guard (K921895, K923657 and K961810) Device Description: Ocu-Guard™ Orbital Implant Wrap and…
Genetic1983—
*K842066Peri-Guard Pericardial Patch
Summary page 1
…sification Name: Implant, Eye Sphere (Accessory) Substantial Equivalence: Oculo-Plastik ePTFE Sheet Covering for Ocular Implant (K934834) Peri-Guard (K821532, K833021, K842066 and K961811) Supple Peri-Guard (K921895, K923657 and K961810) Device Description: Ocu-Guard™ Orbital Implant Wrap and Supple Oc…
Genetic Laboratories, Inc.1985—
*K961811Peri-Guard Pericardium
Summary page 1
…ame: Implant, Eye Sphere (Accessory) Substantial Equivalence: Oculo-Plastik ePTFE Sheet Covering for Ocular Implant (K934834) Peri-Guard (K821532, K833021, K842066 and K961811) Supple Peri-Guard (K921895, K923657 and K961810) Device Description: Ocu-Guard™ Orbital Implant Wrap and Supple Ocu-Guard™ Orb…
Bio-Vascular, Inc.1996—
*K921895Tissue Patch, Tissue Graft
Summary page 1
…ccessory) Substantial Equivalence: Oculo-Plastik ePTFE Sheet Covering for Ocular Implant (K934834) Peri-Guard (K821532, K833021, K842066 and K961811) Supple Peri-Guard (K921895, K923657 and K961810) Device Description: Ocu-Guard™ Orbital Implant Wrap and Supple Ocu-Guard™ Orbital Implant Wrap. Both prod…
Bio-Vascular, Inc.1992—
*K923657Supple Peri-Guard
Summary page 1
…Substantial Equivalence: Oculo-Plastik ePTFE Sheet Covering for Ocular Implant (K934834) Peri-Guard (K821532, K833021, K842066 and K961811) Supple Peri-Guard (K921895, K923657 and K961810) Device Description: Ocu-Guard™ Orbital Implant Wrap and Supple Ocu-Guard™ Orbital Implant Wrap. Both products are…
Bio-Vascular, Inc.1992—
*K961810Supple Peri-Guard Pericardium
Summary page 1
…l Equivalence: Oculo-Plastik ePTFE Sheet Covering for Ocular Implant (K934834) Peri-Guard (K821532, K833021, K842066 and K961811) Supple Peri-Guard (K921895, K923657 and K961810) Device Description: Ocu-Guard™ Orbital Implant Wrap and Supple Ocu-Guard™ Orbital Implant Wrap. Both products are composed of…
Bio-Vascular, Inc.1996—

Also cleared against K934834: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K983581Ocu-Guard and Ocu-Guard SuppleBio-Vascular, Inc.19980

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 12 years and passes through 2 companies; a new generation was cleared every 10.5 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K983581 (Bio-Vascular, Inc., 1998) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K934834.

How does its category compare?

All MTZ devices

MTZ Wrap, Implant, Orbital: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MTZ

FDA has decided no MTZ device since 2007.

Median 510(k) review, days · MTZ

Too few MTZ 510(k)s in any year since 2007 to give a median.

Recalls per year · MTZ

No recall names MTZ since 2007.

Adverse event reports per year · MTZ

No MAUDE report names MTZ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

Ocu-Guard™ and Supple Ocu-Guard™ are 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 and Supple Ocu-Guard allow for tissue ingrowth through the vascularization process and protect the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard and Supple Ocu-Guard also allow for muscle reattachment to faciiitate 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.

Also cleared against K934834

2 other devices cite the same predicate.

  • K083342Orbital Reconstructive Implant IIEvera Medical, Inc. · 2009
  • K070130Orbital Reconstructive ImplantBecker & Associates Consulting, Inc. · 2007

More from Bio-Vascular, Inc.

26 FDA decisions under this applicant name. See the company

  • K002233Bvi SlingBio-Vascular, Inc. · 20001 recall
  • K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and Naoh-TreatedBio-Vascular, Inc. · 2000
  • K983602CV Peri-Guard and Vascu-GuardBio-Vascular, Inc. · 19983 recalls
  • K983581Ocu-Guard and Ocu-Guard SuppleBio-Vascular, Inc. · 1998
  • K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips…Bio-Vascular, Inc. · 19982 recalls

Recent decisions in MTZ

The MTZ category page

  • K023643Macropore Surgical Barrier FilmMacropore Biosurgery, Inc. · 2003

https://510kreport.com/device/K973552 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973552: Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973552

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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