510(k) · Cleared
ClearedShelhigh NO-React Tissue Repair Patch/Uropatch.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shelhigh, Inc. · FTM Mesh, Surgical
Cleared on Jul 14, 1999 as substantially equivalent to K974914 (Shelhigh, Inc., 1998) and 1 other predicate after a 70-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Jul 14, 1999
- Review
- 70 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K964467 (1997). 4 ancestors in all, the oldest K940205 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK964467 Shelhigh Pericardial PatchShelhigh, Inc. · 1997
- 2 generations backK974914 Shelhigh NO-React Pericardial PatchesShelhigh, Inc. · 1998
- 1 generation backK981756 Shelhigh NO-React PneumopledgetsShelhigh, Inc. · 1998
- This deviceK991567 Shelhigh NO-React Tissue Repair Patch/Uropatch.Shelhigh, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964467 | Shelhigh Pericardial Patch | Shelhigh, Inc. | 1997 | — |
| −2 | K974914 | Shelhigh NO-React Pericardial Patches | Shelhigh, Inc. | 1998 | — |
| −1 | K981756 | Shelhigh NO-React Pneumopledgets | Shelhigh, Inc. | 1998 | — |
| 0 (this device) | K991567 | Shelhigh NO-React Tissue Repair Patch/Uropatch. | Shelhigh, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 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? (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 |
|---|---|---|---|
| * | K974914 | Shelhigh NO-React Pericardial PatchesSummary page 1…rmanently implanted material. V. Substantial Equivalence The Shelhigh No-React® Tissue repair patch/UroPatch™ is equivalent to the Shelhigh No-React® pericardial patch K974914, and K981756 currently manufactured by Shelhigh Inc. VI. Comparison with Predicate Device The Shelhigh No-React®… | 1998 |
| * | K981756 | Shelhigh NO-React PneumopledgetsSummary page 1…lanted material. V. Substantial Equivalence The Shelhigh No-React® Tissue repair patch/UroPatch™ is equivalent to the Shelhigh No-React® pericardial patch K974914, and K981756 currently manufactured by Shelhigh Inc. VI. Comparison with Predicate Device The Shelhigh No-React® Tissue repai… | 1998 |
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 2 years and passes through 1 company; a new generation was cleared every 8 months on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K974914.
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?
Tissue repair patch, for the surgical repair of soft tissue deficiencies which include:
defects of the abdominal and thoracic wall, gastric banding , rectal and vaginal prolapse,
urethral sling, reconstruction of the pelvic floor, and hernias, or defects of the diaphragm,
femoral, incisional, inguinal, lumbar, and umbilical hernia.
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/K991567 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991567: Shelhigh NO-React Tissue Repair Patch/Uropatch..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991567
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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