510(k) · Cleared
ClearedTephaflex Surgical 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 Apr 13, 2007 as substantially equivalent to K810428 (ETHICON, Inc., 1981) and 4 other predicates after a 14-day review. Its family tree reaches back 3 generations to 2001. 17 later devices descend from it.
- Decided
- Apr 13, 2007
- Review
- 14 days
- Class
- Class II
- Product code
- OOD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K002699 (2001). 9 ancestors in all, the oldest K810428 (1981). 17 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK002699 Parietex Composite (Pco) MeshMedical Device Consultants, Inc. · 2001
- 2 generations backK031955 Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc. · 2003
- 1 generation backK050332 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005
- This deviceK070894 Tephaflex Surgical MeshTepha, Inc. · 2007
- 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 · cites it directly · 2 of its ownK093799 Tornier Surgical MeshTornier, Inc. · 2010
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · 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
- K093799Tornier Surgical MeshTornier, Inc. · 2010 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002699 | Parietex Composite (Pco) Mesh | Medical Device Consultants, Inc. | 2001 | — |
| −2 | K031955 | Macropore Surgi-Wrap Mast Bioresorbable Sheet | Macropore Biosurgery, Inc. | 2003 | — |
| −1 | K050332 | Surgi-Wrap Mast Bioresorbable Sheet | Mast Biosurgery USA, Inc. | 2005 | — |
| 0 (this device) | K070894 | Tephaflex Surgical Mesh | Tepha, Inc. | 2007 | — |
| +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 | — |
| +1 | K093799 | Tornier Surgical Mesh | Tornier, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 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? (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 |
|---|---|---|---|
| * | K810428 | VicrylSummary page 1…t, the device classification is Class II, Performance Standards. Predicate Devices: Ethicon, Inc. - Vicryl Mesh - K810428, K851086 Tepha, Inc. - TephaFLEX Absorbable Suture - K052225… | 1981 |
| * | K851086 | Vicryl (Polyglactin 910/Mersilene Compoisite MeshSummary page 1…vice classification is Class II, Performance Standards. Predicate Devices: Ethicon, Inc. - Vicryl Mesh - K810428, K851086 Tepha, Inc. - TephaFLEX Absorbable Suture - K052225 MAS… | 1985 |
| * | DEN060003 | Tephaflex Absorbable Suture Our reading of the summary gave K052225, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN060003, Tephaflex Absorbable Suture (Tepha, Inc.), granted Feb 8, 2007; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2007 |
| * | 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, “Surgi-Wrap Film”. | 2003 |
| * | K050332 | Surgi-Wrap Mast Bioresorbable SheetSummary page 1…Inc. - TephaFLEX Absorbable Suture - K052225 MAST Biosurgery, Inc. - Surgi-Wrap Film - K031995, K050332 Device Description: TephaFLEX® Surgical Mesh is to be used wherever tempor… | 2005 |
What descends from it? (17)
See all 177 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 6 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K143380 (C.R. Bard, Inc., 2015) has gone furthest, with 4 descendants of its own.
- 9 other devices also cite its predicate K810428.
How does its category compare?
All OOD devicesOOD Surgical Film: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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® Surgical Mesh is intended wherever temporary wound support is required, to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070894: Tephaflex Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070894
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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