510(k) · Cleared
Recalled · 2011Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synovis Surgical Innovations · FTM Mesh, Surgical
Cleared on Oct 27, 2004 as substantially equivalent to K030879 (Synovis Surgical Innovations, 2003) and 1 other predicate after a 128-day review. Its family tree reaches back 4 generations to 1985. 4 later devices descend from it. It has been recalled 8 times.
- Decided
- Oct 27, 2004
- Review
- 128 days
- Class
- Class II
- Product code
- FTM
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 4 generations to K842066 (1985). 11 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 3 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 2 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 1 generation backK040415 Peri-Strips Staple Line Reinforcement - Sleeve and Strip…Synovis Surgical Innovations · 2004 · Recalled
- This deviceK041669 Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSynovis Surgical Innovations · 2004
- Descendant · cites it directly · 2 of its ownK083039 Veritas Collagen Matrix (Dry)Synovis Surgical Innovations · 2008
- Descendant · cites it directly · 1 of its ownK192615 Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip…Synovis Life Technologies, Inc. (Baxter International Inc.) · 2019
- Descendant · 2 generations on · 0 of its ownK213125 PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen…Synovis Life Technologies. Inc. (A Subsidiary of Baxter · 2021
- Descendant · cites it directly · 0 of its ownK153364 Kerecis SecureMeshKerecis Limited · 2016
Most influential descendants
Showing 4 of 4 · See all- K083039Veritas Collagen Matrix (Dry)Synovis Surgical Innovations · 2008 · cites it directly2descendants
- K192615Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)Synovis Life Technologies, Inc. (Baxter International Inc.) · 2019 · cites it directly1descendant
- K213125PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP…Synovis Life Technologies. Inc. (A Subsidiary of Baxter · 2021 · 2 generations on0descendants
- K153364Kerecis SecureMeshKerecis Limited · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −3 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −2 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −1 | K040415 | Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and… | Synovis Surgical Innovations | 2004 | 1 |
| 0 (this device) | K041669 | Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSD | Synovis Surgical Innovations | 2004 | — |
| +1 | K083039 | Veritas Collagen Matrix (Dry) | Synovis Surgical Innovations | 2008 | — |
| +1 | K192615 | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology… | Synovis Life Technologies, Inc. (Baxter International Inc.) | 2019 | — |
| +2 | K213125 | PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with… | Synovis Life Technologies. Inc. (A Subsidiary of Baxter | 2021 | — |
| +1 | K153364 | Kerecis SecureMesh | Kerecis Limited | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K030879 | Veritas Collagen MatrixSummary page 1…Be Determined Common Name: Surgical Mesh Classification Name: Mesh, Surgical 878.3300 Predicate devices: Veritas® Collagen Matrix, K030879 Synovis Surgical Innovations Peri-Strips Dry (PSD), K040415… | 2003 |
| * | K040415 | Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and…Summary page 1…878.3300 Predicate devices: Veritas® Collagen Matrix, K030879 Synovis Surgical Innovations Peri-Strips Dry (PSD), K040415 Synovis Surgical Innovations Device Description: Veritas Dry is intended to be used as a staple line bu… | 2004 |
What descends from it? (4)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 26, 2011 | Not classified | Z-0274-2012 | Labeling mix-ups | Synovis Surgical Innovations is voluntarily recalling one lot of Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) product because some of the devices were mislabeled. |
| Mar 16, 2007 | Not classified | Z-0965-2007 | Other | Package Integrity/Sterility Compromised-The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray… |
| Mar 16, 2007 | Not classified | Z-0961-2007 | Other | Package Integrity/Sterility Compromised-The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray… |
| Mar 16, 2007 | Not classified | Z-0962-2007 | Other | Package Integrity/Sterility Compromised-The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray… |
| Mar 16, 2007 | Not classified | Z-0963-2007 | Other | Package Integrity/Sterility Compromised-The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray… |
| Mar 16, 2007 | Not classified | Z-0964-2007 | Other | Package Integrity/Sterility Compromised-The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray… |
| Mar 16, 2007 | Not classified | Z-0960-2007 | Other | Package Integrity/Sterility Compromised: The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the… |
| Nov 1, 2005 | Not classified | Z-0764-06 | Other | The Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement devices involved have a small chance that a seal on the outer pouch may not be completely reliable. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K083039 (Synovis Surgical Innovations, 2008) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K030879.
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?
Veritas Dry Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
Veritas Dry can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.
Veritas Dry can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
Veritas Dry is intended to be used for reinforcement of suture-lines and staple-lines (for example: occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041669 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041669: Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041669
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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