510(k) · Cleared
ClearedTephaflex Meltblown Construct
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tepha, Inc. · OOD Surgical Film
Cleared on May 7, 2013 as substantially equivalent to K113723 (Tepha, Inc., 2012) and 4 other predicates after an 88-day review. Its family tree reaches back 7 generations to 1985.
- Decided
- May 7, 2013
- Review
- 88 days
- Class
- Class II
- Product code
- OOD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K842066 (1985). 47 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 7 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 6 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 5 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 4 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 3 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 2 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 1 generation backK033671 Gore Bioabsorbable MeshW. L. Gore & Associates, Inc. · 2003
- This deviceK130326 Tephaflex Meltblown ConstructTepha, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −6 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −5 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −4 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −3 | 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 | — |
| −1 | K033671 | Gore Bioabsorbable Mesh | W. L. Gore & Associates, Inc. | 2003 | — |
| 0 (this device) | K130326 | Tephaflex Meltblown Construct | Tepha, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 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 OOD? 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 OOD device
- #1 K233999 GalaFLEX LITE Scaffoldscore 7.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K113723 | Tephaflex MeshSummary page 1…smetic Act, the device classification is Class 11,Performance Standards. Predicate Devices: TephaFLEX Surgical Mesh - K1 13723 Cook Biadesign Surgisis Tissue Graft - K062696 Gore Rio-A T… | 2012 |
| * | K062696 | Surgisis, Surgisis ESSummary page 1…1,Performance Standards. Predicate Devices: TephaFLEX Surgical Mesh - K1 13723 Cook Biadesign Surgisis Tissue Graft - K062696 Gore Rio-A Tissue Reinforcement - K033671 MAST Biosurgery S… | 2006 |
| * | K033671 | Gore Bioabsorbable MeshSummary page 1…al Mesh - K1 13723 Cook Biadesign Surgisis Tissue Graft - K062696 Gore Rio-A Tissue Reinforcement - K033671 MAST Biosurgery Surgi-Wrap - K031995, K050332 Please see t… | 2003 |
| * | K031955 | Macropore Surgi-Wrap Mast Bioresorbable Sheet Our reading of the summary gave K031995, FDA’s number for Comprehensive Neuromuscular Profiler (Medical Technologies Unlimited, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “MAST Biosurgery Surgi-Wrap”. | 2003 |
| * | K050332 | Surgi-Wrap Mast Bioresorbable SheetSummary page 1…sue Graft - K062696 Gore Rio-A Tissue Reinforcement - K033671 MAST Biosurgery Surgi-Wrap - K031995, K050332 Please see the attached Substantial Equivalence table comparing the… | 2005 |
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 28 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 47 ancestors have a recall of any class.
- 3 other devices also cite its predicate K113723.
How does its category compare?
All OOD devicesOOD Surgical Film: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OOD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OOD
Too few OOD 510(k)s in any year since 2007 to give a median.
Recalls per year · OOD
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OOD
111in 2025
MAUDE reports naming product code OOD, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 2 | — | 1 | 9 |
| 2017 | 1 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 0 | — | 0 | 17 |
| 2020 | 0 | — | 0 | 71 |
| 2021 | 1 | — | 0 | 98 |
| 2022 | 0 | — | 0 | 430 |
| 2023 | 0 | — | 0 | 126 |
| 2024 | 1 | — | 0 | 196 |
| 2025 | 0 | — | 0 | 111 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
TephaFLEX Melt blown Matrix is intended to reinforce soft tissue where weakness exists in patients undergoing surgical procedures that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130326: Tephaflex Meltblown Construct.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130326
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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