510(k) · Cleared
ClearedPhasix ST Mesh with Echo 2 Positioning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Dec 14, 2018 as substantially equivalent to K170294 (C. R. Bard, 2017) and 1 other predicate after a 140-day review. Its family tree reaches back 11 generations to 1997.
- Decided
- Dec 14, 2018
- Review
- 140 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K971745 (1997). 90 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 11 generations backK971745 Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc. · 1997
- 7 generations between
- 3 generations backK130968 Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · Recalled
- 2 generations backK143743 ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc. · 2015
- 1 generation backK170294 VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”)…C. R. Bard · 2017
- This deviceK182008 Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc. · 2018
Show all 11 generations
- Root · 11 generations backK971745 Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc. · 1997
- 10 generations backK994328 Sepramesh Biosurgical Composite, Model SMBC-XXXGenzyme Corp. · 2000
- 9 generations backK040868 Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp. · 2004
- 8 generations backK053066 Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 2005
- 7 generations backK063739 Sepramesh, Model 5959-1214Genzyme Corporation · 2007
- 6 generations backK101851 Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc. · 2010 · Recalled
- 5 generations backK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
- 4 generations backK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled
- 3 generations backK130968 Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · Recalled
- 2 generations backK143743 ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc. · 2015
- 1 generation backK170294 VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”)…C. R. Bard · 2017
- This deviceK182008 Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K971745 | Bard Composite Prosthesis | Davol Inc., Sub. C. R. Bard, Inc. | 1997 | — |
| −10 | K994328 | Sepramesh Biosurgical Composite, Model SMBC-XXX | Genzyme Corp. | 2000 | — |
| −9 | K040868 | Sepramesh IP Bioresorbable Barrier - Permanent Mesh | Genzyme Corp. | 2004 | — |
| −8 | K053066 | Sepramesh IP Bioresorbable Coating/Permanent Mesh | Genzyme Corporation | 2005 | — |
| −7 | K063739 | Sepramesh, Model 5959-1214 | Genzyme Corporation | 2007 | — |
| −6 | K101851 | Ventralight ST Mesh | Davol Inc., Sub. C. R. Bard, Inc. | 2010 | 2 |
| −5 | K110820 | Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System | C.R. Bard, Inc. | 2011 | — |
| −4 | K122436 | Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with… | C.R. Bard, Inc. | 2012 | 15 |
| −3 | K130968 | Ventralight ST Mesh with Echo PS Positioning System | C.R. Bard, Inc. | 2013 | 4 |
| −2 | K143743 | ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH | C.R. Bard, Inc. | 2015 | — |
| −1 | K170294 | VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle… | C. R. Bard | 2017 | — |
| 0 (this device) | K182008 | Phasix ST Mesh with Echo 2 Positioning System | C.R. Bard, Inc. | 2018 | — |
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 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 8 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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 |
|---|---|---|---|
| * | K170294 | VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST…Summary page 5…e: OWT, OOD, FTL, ORQ, GCJ Page 1 of7 Page 52 of 421 Il Primary Predicate Device: Name of Device: Ventralight™ ST Mesh with Echo 2™ Positioning System (K170294), cleared on May 1% 2017 Common or Usual Name: Surgical Mesh Classification Name: Mesh, Surgical, Polymeric Classification Pan… | 2017 |
| * | K173143 | Phasix ST MeshSummary page 5…Surgery Regulatory Class: Class Il Regulation Number: 21 CFR § 878.3300 Product Code: FTL, ORQ, GCJ IV. Secondary Predicate Device: Name of Device: Phasix™ ST Mesh (K173143) cleared on April 25", 2018. Common or Usual Name: Surgical Mesh Classification Name: Mesh, Surgical, Absorbable, Abdominal Hern… | 2018 |
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 21 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 8 of the 90 ancestors have a recall of any class.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Phasix™ ST Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as for the repair of hemias.
The Echo 2™ Positioning System is intended to facilitate the delivery and positioning of the mesh during laparoscopic hernia repair.
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/K182008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182008: Phasix ST Mesh with Echo 2 Positioning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182008
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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