510(k) · Cleared
ClearedPeri-Strips Dry - Staple Line Reinforcement
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 May 9, 1997 as substantially equivalent to K942583 (Bio-Vascular, Inc., 1994) and 1 other predicate after a 49-day review. Its family tree reaches back 1 generation to 1994. 148 later devices descend from it.
- Decided
- May 9, 1997
- Review
- 49 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K940205 (1994). 2 ancestors in all. 148 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK940205 Peri-StripsBio-Vascular, Inc. · 1994
- This deviceK971048 Peri-Strips Dry - Staple Line ReinforcementBio-Vascular, Inc. · 1997
- Descendant · cites it directly · 147 of its ownK992537 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
Showing 5 of 148 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 148 · See all- K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and…Bio-Vascular, Inc. · 2000 · cites it directly147descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940205 | Peri-Strips | Bio-Vascular, Inc. | 1994 | — |
| 0 (this device) | K971048 | Peri-Strips Dry - Staple Line Reinforcement | Bio-Vascular, Inc. | 1997 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K942583 | Peri-Strips Planar Configuration Staple Line ReinforcementSummary page 1…ommon or Usual Name: Peri-Strips Dry - Staple Line Reinforcement Device Classification Name: Surgical Patch Substantial Equivilance: Peri-Strips - Strips Configuration K942583 & Peri-Strips - Sleeve Configuration K940205 Device Description: Dehydrated bovine pericardium strips cross-linked with glutarai… | 1994 |
| * | K940205 | Peri-StripsSummary page 1…Line Reinforcement Device Classification Name: Surgical Patch Substantial Equivilance: Peri-Strips - Strips Configuration K942583 & Peri-Strips - Sleeve Configuration K940205 Device Description: Dehydrated bovine pericardium strips cross-linked with glutaraidehyde. Affixed to the stapler forks with PSD… | 1994 |
What descends from it? (148)
See all 1482 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?
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?
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.
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/K971048 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971048: Peri-Strips Dry - Staple Line Reinforcement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971048
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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