510(k) · Cleared
ClearedUltrapro Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Apr 1, 2004 after a 167-day review. The FDA summary names its predicate without a number. 82 later devices descend from it.
- Decided
- Apr 1, 2004
- Review
- 167 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
82 later devices descend from it, 9 citing it directly.
- This deviceK033337 Ultrapro MeshETHICON, Inc. · 2004
- Descendant · cites it directly · 44 of its ownK052830 SportmeshArtimplant AB · 2006
- Descendant · 2 generations on · 28 of its ownK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- Descendant · cites it directly · 20 of its ownK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
- Descendant · 2 generations on · 17 of its ownK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
- Descendant · 2 generations on · 13 of its ownK092207 Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 82 · See all- K052830SportmeshArtimplant AB · 2006 · cites it directly44descendants
- K071887Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007 · 2 generations on28descendants
- K071512Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008 · cites it directly20descendants
- K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008 · 2 generations on17descendants
- K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc. · 2009 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033337 | Ultrapro Mesh | ETHICON, Inc. | 2004 | — |
| +1 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| +2 | K071887 | Sportmesh or Artelon Tissue Reinforcement | Artimplant AB | 2007 | — |
| +1 | K071512 | Gynecare Prolift +M* Pelvic Floor Repair Systems | ETHICON, Inc. | 2008 | — |
| +2 | K070961 | Biomerix Surgical Mesh, Model: RCR-01 | Biomerix Corporation | 2008 | — |
| +2 | K092207 | Restorelle Polypropylene Mesh | Mpathy Medical Devices, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 6 | 0 |
| 2010 | 7 | 0 |
| 2011 | 7 | 0 |
| 2012 | 10 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | — | VYPRO Mesh Named without a submission number | |
| * | — | PROLENE Polypropylene Mesh Named without a submission number | |
| * | — | MERSILENE Mesh Named without a submission number |
What descends from it? (82)
See all 829 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052830 | Sportmesh | 2006 | 44 |
| K071512 | Gynecare Prolift +M* Pelvic Floor Repair Systems | 2008 | 20 |
| K093932 | Ethicon Physiomesh, Flexible Composite Mesh | 2010 | 5 |
| K092224 | Tigr Surgical Mesh , Model WK-6 | 2010 | 3 |
| K150906 | ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh | 2015 | 1 |
| K070224 | Ultrapro Plug | 2007 | 1 |
| K180910 | ULTRAPRO Mesh and ULTRAPRO ADVANCED | 2018 | 0 |
| K120844 | Medlinx Surgical Mesh | 2012 | 0 |
| K111695 | Hybrid Graft | 2012 | 0 |
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?
- Of its descendants, K052830 (Artimplant AB, 2006) has gone furthest, with 44 descendants of its own.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Is for the "repair ofhemias and other abdominalfascial deficiencies that requie the addition of a reinforcing or bridging maedl to obtain the desired surgical rcsult."
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033337: Ultrapro Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033337
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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