510(k) · Cleared
ClearedPhasix ST Umbilical Hernia Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davol, Inc., A Subsidiary of C.R. Bard, Inc. · OWT Mesh, Surgical, Absorbable, Abdominal Hernia
Cleared on Feb 19, 2025 as substantially equivalent to K101928 (C.R. Bard, Inc., 2011) and 1 other predicate after a 132-day review. Its family tree reaches back 7 generations to 1997.
- Decided
- Feb 19, 2025
- Review
- 132 days
- Class
- Class II
- Product code
- OWT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K971745 (1997). 22 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 7 generations backK971745 Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc. · 1997
- 6 generations backK994328 Sepramesh Biosurgical Composite, Model SMBC-XXXGenzyme Corp. · 2000
- 5 generations backK040868 Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp. · 2004
- 4 generations backK053066 Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 2005
- 3 generations backK063739 Sepramesh, Model 5959-1214Genzyme Corporation · 2007
- 2 generations backK101920 Ventrio ST Hernia PatchC.R. Bard, Inc. · 2011
- 1 generation backK190185 Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc. · 2019
- This deviceK243241 Phasix ST Umbilical Hernia PatchDavol, Inc., A Subsidiary of C.R. Bard, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971745 | Bard Composite Prosthesis | Davol Inc., Sub. C. R. Bard, Inc. | 1997 | — |
| −6 | K994328 | Sepramesh Biosurgical Composite, Model SMBC-XXX | Genzyme Corp. | 2000 | — |
| −5 | K040868 | Sepramesh IP Bioresorbable Barrier - Permanent Mesh | Genzyme Corp. | 2004 | — |
| −4 | K053066 | Sepramesh IP Bioresorbable Coating/Permanent Mesh | Genzyme Corporation | 2005 | — |
| −3 | K063739 | Sepramesh, Model 5959-1214 | Genzyme Corporation | 2007 | — |
| −2 | K101920 | Ventrio ST Hernia Patch | C.R. Bard, Inc. | 2011 | — |
| −1 | K190185 | Phasix ST Mesh with Open Positioning System | C.R. Bard, Inc. | 2019 | — |
| 0 (this device) | K243241 | Phasix ST Umbilical Hernia Patch | Davol, Inc., A Subsidiary of C.R. Bard, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 OWT? 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 OWT device
- #1 K261543 Phasix ST Parastomal Hernia Meshscore 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K101928 | Ventralex ST Hernia PatchSummary page 5…: 21 CFR 878.3300 Product Codes: OWT, OOD, FTL Primary Predicate Device: Name of Device: Ventralex™ ST Hernia Patch (K101928), cleared on March 23, 2011 Common or Usual Name: Surgical Mesh Classification… | 2011 |
| * | K190185 | Phasix ST Mesh with Open Positioning SystemSummary page 6…K243241 Page 1 of 8 Name of Device: Phasix™ ST Mesh with Open Positioning System (K190185), cleared on June 12, 2019 Common or Usual Name: Surgical Mesh Classification Name: Mesh, Surgical, Ab… | 2019 |
| † | K142818 | Phasix Mesh | 2015 |
| † | K143380 | Phasix ST Mesh | 2015 |
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 4.2 years on median.
- 4 of the 22 ancestors have a recall of any class.
How does its category compare?
All OWT devicesOWT Mesh, Surgical, Absorbable, Abdominal Hernia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OWT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWT
Too few OWT 510(k)s in any year since 2007 to give a median.
Recalls per year · OWT
No recall names OWT since 2007.
Adverse event reports per year · OWT
82in 2025
MAUDE reports naming product code OWT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 7 |
| 2018 | 1 | — | 0 | 31 |
| 2019 | 2 | — | 0 | 61 |
| 2020 | 1 | — | 0 | 45 |
| 2021 | 0 | — | 0 | 58 |
| 2022 | 0 | — | 0 | 104 |
| 2023 | 0 | — | 0 | 76 |
| 2024 | 1 | — | 0 | 65 |
| 2025 | 1 | — | 0 | 82 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Phasix™ ST Umbilical Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving the repair of umbilical hernias.
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/K243241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243241: Phasix ST Umbilical Hernia Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243241
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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