510(k) · Cleared
ClearedGlycar Tissue Repair Patch, Bio-Patch, Uro-Sling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glycar, Inc. · FTM Mesh, Surgical
Cleared on Sep 23, 1996 as substantially equivalent to K923657 (Bio-Vascular, Inc., 1992) after a 40-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Sep 23, 1996
- Review
- 40 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923657 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK923657 Supple Peri-GuardBio-Vascular, Inc. · 1992
- This deviceK963175 Glycar Tissue Repair Patch, Bio-Patch, Uro-SlingGlycar, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923657 | Supple Peri-Guard | Bio-Vascular, Inc. | 1992 | — |
| 0 (this device) | K963175 | Glycar Tissue Repair Patch, Bio-Patch, Uro-Sling | Glycar, Inc. | 1996 | — |
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 FTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K923657 | Supple Peri-GuardSummary page 1…ue Patch . ED.A. Device Classification Class II Device 5. Predi Devi The predicate device is the Tissue Guard™ product line, including Supple Peri-Guard™ product line (K923657), and is a tissue patch made from glutaraldehyde-treated bovine pericardium. The device is produced by Bio-Vascular Inc., 2670 Pa… | 1992 |
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?
- Its one ancestor has no recall.
- 8 other devices also cite its predicate K923657.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The predicate device, the Peri-Guard™ family of glutaraldehyde-treated bovine pericardium tissue patch has been used for pericardial closures, the repair of abdominal and thoracic wall defects, inguinal, paracolostomy, ventral, paraumbilical, scrotal, femoral and other hernias, urethral slings, reconstruction of pelvic floor, repair of rectal and vaginal prolapse, suture and staple bolsters, pledgets and slings, and other soft tissue repair, reinforcement, and reconstruction without any significant reported patient morbidity or mortality attributed to material failures.
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/K963175 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963175: Glycar Tissue Repair Patch, Bio-Patch, Uro-Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963175
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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