510(k) · Cleared
ClearedHydrocoat Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promethean Surgical Devices, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Jan 14, 2010 as substantially equivalent to K980483 (Mentor Corp., 1998) and 3 other predicates after a 344-day review. Its family tree reaches back 9 generations to 1992. 6 later devices descend from it.
- Decided
- Jan 14, 2010
- Review
- 344 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K921895 (1992). 43 ancestors in all, the oldest K830889 (1983). 6 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations between
- 3 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 2 generations backK052830 SportmeshArtimplant AB · 2006
- 1 generation backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- This deviceK090271 Hydrocoat MeshPromethean Surgical Devices, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK093524 Pivit a/B ST and Pivit a/B ST-RTyrx, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK113229 Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK133223 Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014
- Descendant · 4 generations on · 1 of its ownK151177 XenMatrix AB Surgical GraftC. R. Bard · 2015
- Descendant · 2 generations on · 0 of its ownK211132 ARISTE AB MeshAriste Medical, LLC · 2022
Show all 9 generations
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 8 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 7 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 6 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 5 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 4 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 3 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 2 generations backK052830 SportmeshArtimplant AB · 2006
- 1 generation backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- This deviceK090271 Hydrocoat MeshPromethean Surgical Devices, Inc. · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K093524Pivit a/B ST and Pivit a/B ST-RTyrx, Inc. · 2010 · cites it directly5descendants
- K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc. · 2012 · 2 generations on3descendants
- K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014 · 3 generations on2descendants
- K151177XenMatrix AB Surgical GraftC. R. Bard · 2015 · 4 generations on1descendant
- K211132ARISTE AB MeshAriste Medical, LLC · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −8 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −7 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −6 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −5 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −3 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −2 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| −1 | K071887 | Sportmesh or Artelon Tissue Reinforcement | Artimplant AB | 2007 | — |
| 0 (this device) | K090271 | Hydrocoat Mesh | Promethean Surgical Devices, Inc. | 2010 | — |
| +1 | K093524 | Pivit a/B ST and Pivit a/B ST-R | Tyrx, Inc. | 2010 | — |
| +2 | K113229 | Ventrio Light Hernia Patch with TRM Antimicrobial Coating | C.R. Bard, Inc. | 2012 | — |
| +3 | K133223 | Xenmatrix AB Surgical Graft | C.R. Bard, Inc. | 2014 | — |
| +4 | K151177 | XenMatrix AB Surgical Graft | C. R. Bard | 2015 | — |
| +2 | K211132 | ARISTE AB Mesh | Ariste Medical, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 7 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K980483 | Mentor Suspend SlingSummary page 3…principles with the following predicate devices which have been determined by FDA to be substantially equivalent to pme-amendment devices: Mentor Suspend Sling (K980483), Artimplant AB SportMesh / Artelon Tissue Reinforcement (K07 1887), Artimplant AB SportMesh (K052830), the Mpathy Medi… | 1998 |
| * | K071887 | Sportmesh or Artelon Tissue ReinforcementSummary page 3…ermined by FDA to be substantially equivalent to pme-amendment devices: Mentor Suspend Sling (K980483), Artimplant AB SportMesh / Artelon Tissue Reinforcement (K07 1887), Artimplant AB SportMesh (K052830), the Mpathy Medical Minimesh (K041632), and the Ethicon Mersilene Mesh (pre-amendme… | 2007 |
| * | K052830 | SportmeshSummary page 3…quivalent to pme-amendment devices: Mentor Suspend Sling (K980483), Artimplant AB SportMesh / Artelon Tissue Reinforcement (K07 1887), Artimplant AB SportMesh (K052830), the Mpathy Medical Minimesh (K041632), and the Ethicon Mersilene Mesh (pre-amendment); Class II medical devices that were… | 2006 |
| * | K041632 | Minimesh Polypropylene MeshSummary page 3…tor Suspend Sling (K980483), Artimplant AB SportMesh / Artelon Tissue Reinforcement (K07 1887), Artimplant AB SportMesh (K052830), the Mpathy Medical Minimesh (K041632), and the Ethicon Mersilene Mesh (pre-amendment); Class II medical devices that were cleared for marketing in the Unite… | 2004 |
| * | — | Ethicon Mersilene Mesh Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093524 | Pivit a/B ST and Pivit a/B ST-R | 2010 | 5 |
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 18 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 43 ancestors have a recall of any class.
- Of its descendants, K093524 (Tyrx, Inc., 2010) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K980483.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The HydroCoat Mesh is indicated for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The HydraCoat Mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional hernia, uterovaginal prolapse and other fascial deficiencies that require support material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090271: Hydrocoat Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090271
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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