510(k) · Cleared
ClearedPhasix Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C. R. Bard · OOD Surgical Film
Cleared on Mar 31, 2015 as substantially equivalent to K113723 (Tepha, Inc., 2012) and 2 other predicates after a 183-day review. Its family tree reaches back 4 generations to 2001. 3 later devices descend from it.
- Decided
- Mar 31, 2015
- Review
- 183 days
- Class
- Class II
- Product code
- OOD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K002699 (2001). 12 ancestors in all, the oldest K810428 (1981). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK002699 Parietex Composite (Pco) MeshMedical Device Consultants, Inc. · 2001
- 3 generations backK031955 Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc. · 2003
- 2 generations backK050332 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005
- 1 generation backK070894 Tephaflex Surgical MeshTepha, Inc. · 2007
- This deviceK142818 Phasix MeshC. R. Bard · 2015
- Descendant · cites it directly · 2 of its ownK161424 Phasix MeshC.R. Bard, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK191749 TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB · 2020
- Descendant · 3 generations on · 0 of its ownK233661 Transorb™ Self-Gripping Resorbable MeshSofradim Production · 2024
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 |
|---|---|---|---|---|---|
| −4 | K002699 | Parietex Composite (Pco) Mesh | Medical Device Consultants, Inc. | 2001 | — |
| −3 | K031955 | Macropore Surgi-Wrap Mast Bioresorbable Sheet | Macropore Biosurgery, Inc. | 2003 | — |
| −2 | K050332 | Surgi-Wrap Mast Bioresorbable Sheet | Mast Biosurgery USA, Inc. | 2005 | — |
| −1 | K070894 | Tephaflex Surgical Mesh | Tepha, Inc. | 2007 | — |
| 0 (this device) | K142818 | Phasix Mesh | C. R. Bard | 2015 | — |
| +1 | K161424 | Phasix Mesh | C.R. Bard, Inc. | 2016 | — |
| +2 | K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | Novus Scientific AB | 2020 | — |
| +3 | K233661 | Transorb™ Self-Gripping Resorbable Mesh | Sofradim Production | 2024 | — |
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 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K113723 | Tephaflex MeshSummary page 4…78.3300) Regulatory Class: Class II Product Code: OOD III. Predicate Device x TephaFLEX® Mesh o K113723 (Tepha, Inc.), FDA cleared on February 15, 2012 o K111946 (Tepha Inc.), FDA cleared on September 26, 2011… | 2012 |
| * | K111946 | Tephaflex MeshSummary page 4…OOD III. Predicate Device x TephaFLEX® Mesh o K113723 (Tepha, Inc.), FDA cleared on February 15, 2012 o K111946 (Tepha Inc.), FDA cleared on September 26, 2011 o K070894 (Tepha Inc.), FDA cleared on April 13, 2007… | 2011 |
| * | K070894 | Tephaflex Surgical MeshSummary page 4…LEX® Mesh o K113723 (Tepha, Inc.), FDA cleared on February 15, 2012 o K111946 (Tepha Inc.), FDA cleared on September 26, 2011 o K070894 (Tepha Inc.), FDA cleared on April 13, 2007 PREMARKET NOTIFICATION FOR PHASIX™ MESH… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161424 | Phasix Mesh | 2016 | 2 |
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 14 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K161424 (C.R. Bard, Inc., 2016) has gone furthest, with 2 descendants 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. 2015, 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 Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142818 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142818: Phasix Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142818
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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