510(k) · Cleared
ClearedPeri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and Naoh-Treated
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Vascular, Inc. · FTM Mesh, Surgical
Cleared on Feb 22, 2000 as substantially equivalent to K983162 (Bio-Vascular, Inc., 1998) and 1 other predicate after a 208-day review. Its family tree reaches back 3 generations to 1985. 147 later devices descend from it.
- Decided
- Feb 22, 2000
- Review
- 208 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K842066 (1985). 9 ancestors in all. 147 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 2 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 1 generation backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- This deviceK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- Descendant · cites it directly · 145 of its ownK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- Descendant · 2 generations on · 143 of its ownK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- Descendant · 3 generations on · 102 of its ownK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- Descendant · 3 generations on · 77 of its ownK043056 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004
- Descendant · 4 generations on · 69 of its ownK040119 Peri-Strips Staple Line Reinforcement-Sleeve Configuration…Synovis Surgical Innovations · 2004
Showing 5 of 147 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 147 · See all- K014183Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002 · cites it directly145descendants
- K030782Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · 2 generations on143descendants
- K032865Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003 · 3 generations on102descendants
- K043056Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004 · 3 generations on77descendants
- K040119Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line…Synovis Surgical Innovations · 2004 · 4 generations on69descendants
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 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| 0 (this device) | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| +1 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| +2 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| +3 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| +3 | K043056 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2004 | — |
| +4 | K040119 | Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple… | Synovis Surgical Innovations | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 7 | 0 |
| 2013 | 10 | 0 |
| 2014 | 10 | 0 |
| 2015 | 7 | 0 |
| 2016 | 10 | 0 |
| 2017 | 15 | 0 |
| 2018 | 10 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 0 |
| 2022 | 10 | 0 |
| 2023 | 9 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…Summary page 1…e and Peri- Strips® — Strip and Peri-Strips Dry™ (NaOH-trested) Device Classification Name: mesh, surgical, polymeric Substantial Equivalence: * Peri-Strips® - Sleeve (K983162), Peri-Strips® = Strip (K983162) and Peri-Strips Dry™ (K971048) [non-NaOH- treated]; e Peri-Strips® — Sleeve (K983162), Peri-Stri… | 1998 |
| * | K971048 | Peri-Strips Dry - Staple Line ReinforcementSummary page 1…Device Classification Name: mesh, surgical, polymeric Substantial Equivalence: * Peri-Strips® - Sleeve (K983162), Peri-Strips® = Strip (K983162) and Peri-Strips Dry™ (K971048) [non-NaOH- treated]; e Peri-Strips® — Sleeve (K983162), Peri-Strips® — Strip (K983162) and Peri-Strips Dry™ (K983162) [NaOH-trea… | 1997 |
What descends from it? (147)
See all 1472 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K014183 (J&J Corporate Biomaterials Center, 2002) has gone furthest, with 145 descendants of its own.
- 12 other devices also cite its predicate K983162.
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?
Peri-Strips Dry is intended to reinforce staple lines during lung and bronchus resections including: pneumonectomy, pneumoreduction, pneumectomy, segmentectomies, (segmental resections), wedge resections, blebectomies, lobectomies, bullectomies, bronchial resections and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass…
Read the full statement (718 words)
Peri-Strips Dry is intended to reinforce staple lines during lung and bronchus resections including: pneumonectomy, pneumoreduction, pneumectomy, segmentectomies, (segmental resections), wedge resections, blebectomies, lobectomies, bullectomies, bronchial resections and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.
Peri-Strips Dry is intended to reinforce staple lines during lung and bronchus resections including: pneumonectomy, pneumoreduction, pneumectomy, segmentectomies, (segmental resections), wedge resections, blebectomies, lobectomies, bullectomies, bronchial resections and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.
Peri-Strips is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. Peri-Strips can be used to reinforce staple lines during lung resections including pneumonectomy, pneumoreduction, pneumectomy, lobectomies, segmentectomies (segmental resections), wedge resections, bullectomies, blebectomies, bronchial resections, and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. Other soft tissue deficiencies amenable to repair with Peri-Strips include defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias). Peri-Strips may be used with anastomotic staplers (when tissue division is desired) or with non-anastomotic staplers (when no tissue division is desired) according to the above indications.
Peri-Strips is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. Peri-Strips can be used to reinforce staple lines during lung resections including pneumonectomy, pneumoreduction, pneumectomy, lobectomies, segmentectomies (segmental resections), wedge resections, bullectomies, blebectomies, bronchial resections, and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. Other soft tissue deficiencies amenable to repair with Peri-Strips include defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias). Peri-Strips may be used with anastomotic staplers (when tissue division is desired) or with non-anastomotic staplers (when no tissue division is desired) according to the above indications.
Peri-Strips is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. Peri-Strips can be used to reinforce staple lines during lung resections including pneumonectomy, pneumoreduction, pneumectomy, lobectomies, segmentectomies (segmental resections), wedge resections, bullectomies, blebectomies, bronchial resections, and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. Other soft tissue deficiencies amenable to repair with Peri-Strips include defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias). Peri-Strips may be used with anastomotic staplers (when tissue division is desired) or with non-anastomotic staplers (when no tissue division is desired) according to the above indications.
Peri-Strips is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. Peri-Strips can be used to reinforce staple lines during lung resections including pneumonectomy, pneumoreduction, pneumectomy, lobectomies, segmentectomies (segmental resections), wedge resections, bullectomies, blebectomies, bronchial resections, and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. Other soft tissue deficiencies amenable to repair with Peri-Strips include defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias). Peri-Strips may be used with anastomotic staplers (when tissue division is desired) or with non-anastomotic staplers (when no tissue division is desired) according to the above indications.
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/K992537 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992537: Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and Naoh-Treated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992537
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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