510(k) · Cleared
ClearedTephaflex Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tepha, Inc. · OOD Surgical Film
Cleared on Sep 26, 2011 after an 80-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Sep 26, 2011
- Review
- 80 days
- Class
- Class II
- Product code
- OOD
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 4 citing it directly.
- This deviceK111946 Tephaflex MeshTepha, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK143380 Phasix ST MeshC.R. Bard, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK142818 Phasix MeshC. R. Bard · 2015
- Descendant · cites it directly · 3 of its ownK140533 Galaflex MeshTepha, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK161424 Phasix MeshC.R. Bard, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK191749 TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K143380Phasix ST MeshC.R. Bard, Inc. · 2015 · cites it directly4descendants
- K142818Phasix MeshC. R. Bard · 2015 · cites it directly3descendants
- K140533Galaflex MeshTepha, Inc. · 2014 · cites it directly3descendants
- K161424Phasix MeshC.R. Bard, Inc. · 2016 · 2 generations on2descendants
- K191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111946 | Tephaflex Mesh | Tepha, Inc. | 2011 | — |
| +1 | K143380 | Phasix ST Mesh | C.R. Bard, Inc. | 2015 | — |
| +1 | K142818 | Phasix Mesh | C. R. Bard | 2015 | — |
| +1 | K140533 | Galaflex Mesh | Tepha, Inc. | 2014 | — |
| +2 | K161424 | Phasix Mesh | C.R. Bard, Inc. | 2016 | — |
| +3 | K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | Novus Scientific AB | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | — | TephaFLEX® Surgical Mesh Named without a submission number | |
| * | — | TephaFLEX® Composite Mesh Named without a submission number | |
| * | — | SupraMESH EXTRATM Named without a submission number |
What descends from it? (14)
See all 144 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?
- Of its descendants, K143380 (C.R. Bard, Inc., 2015) has gone furthest, with 4 descendants of its own.
How does its category compare?
All OOD devicesOOD Surgical Film: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The TephaFLEX® mesh is intended to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desire surgical result.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111946: Tephaflex Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111946
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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