510(k) · Cleared
ClearedGalaflex 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 May 21, 2014 as substantially equivalent to K113723 (Tepha, Inc., 2012) and 4 other predicates after a 78-day review. Its family tree reaches back 11 generations to 1992. 3 later devices descend from it.
- Decided
- May 21, 2014
- Review
- 78 days
- Class
- Class II
- Product code
- OOD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K921895 (1992). 60 ancestors in all, the oldest K810428 (1981). 3 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations between
- 3 generations backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- 2 generations backK083898 SurgimendTei Biosciences, Inc. · 2009 · Recalled
- 1 generation backK123128 Seri Surgical ScaffoldAllergan · 2013
- This deviceK140533 Galaflex MeshTepha, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK161092 GalaSHAPE 3DTepha, Inc. · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK202425 SurgiLattice scaffoldTepha, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK162922 GalaFORM 3DTepha, Inc. · 2017
Show all 11 generations
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 10 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 9 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 8 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 7 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 6 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 5 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 4 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 3 generations backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- 2 generations backK083898 SurgimendTei Biosciences, Inc. · 2009 · Recalled
- 1 generation backK123128 Seri Surgical ScaffoldAllergan · 2013
- This deviceK140533 Galaflex MeshTepha, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −10 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −9 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −8 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −7 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −6 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −5 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −4 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| −3 | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | 4 |
| −2 | K083898 | Surgimend | Tei Biosciences, Inc. | 2009 | 3 |
| −1 | K123128 | Seri Surgical Scaffold | Allergan | 2013 | — |
| 0 (this device) | K140533 | Galaflex Mesh | Tepha, Inc. | 2014 | — |
| +1 | K161092 | GalaSHAPE 3D | Tepha, Inc. | 2016 | 1 |
| +1 | K202425 | SurgiLattice scaffold | Tepha, Inc. | 2021 | — |
| +1 | K162922 | GalaFORM 3D | Tepha, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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 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…osmetic Act, the device classification is Class 11,Performance Standards. Predicate Devices: Tepha, Inc., TephaFLEX Mesh -K1 13723, K<111946, K<101287 and K<070894 Allergan, SERI Surgical Scaff… | 2012 |
| * | K111946 | Tephaflex MeshSummary page 1…Act, the device classification is Class 11,Performance Standards. Predicate Devices: Tepha, Inc., TephaFLEX Mesh -K1 13723, K<111946, K<101287 and K<070894 Allergan, SERI Surgical Scaffold - K<12… | 2011 |
| * | K101287 | Tephaflex Composite MeshSummary page 1…Act, the device classification is Class 11,Performance Standards. Predicate Devices: Tepha, Inc., TephaFLEX Mesh -K1 13723, K<111946, K<101287 and K<070894 Allergan, SERI Surgical Scaffold - K<123128… | 2010 |
| * | K070894 | Tephaflex Surgical MeshSummary page 1…ion is Class 11,Performance Standards. Predicate Devices: Tepha, Inc., TephaFLEX Mesh -K1 13723, K<111946, K<101287 and K<070894 Allergan, SERI Surgical Scaffold - K<123128 Please see attach… | 2007 |
| * | K123128 | Seri Surgical ScaffoldSummary page 1…, Inc., TephaFLEX Mesh -K1 13723, K<111946, K<101287 and K<070894 Allergan, SERI Surgical Scaffold - K<123128 Please see attached Substantial Equivalence table comparing th… | 2013 |
What descends from it? (3)
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)
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 22 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 60 ancestors have a recall of any class.
- Of its descendants, K161092 (Tepha, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 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. 2014, 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?
GalaFLEX mesh is indicated for use as a transitory scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140533 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140533: Galaflex Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140533
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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