510(k) · Cleared
ClearedTimesh Also Known as Timesh-TC, Models 6000001 & 6000004
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gfe Medizintechnik GmbH · FTL Mesh, Surgical, Polymeric
Cleared on Sep 29, 2003 after a 165-day review. The summary cites 3 numbers, none of which could be confirmed as its predicate (see the table below). 42 later devices descend from it.
- Decided
- Sep 29, 2003
- Review
- 165 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
42 later devices descend from it, 3 citing it directly.
- This deviceK031225 Timesh Also Known as Timesh-TC, Models 6000001 & 6000004Gfe Medizintechnik GmbH · 2003
- Descendant · cites it directly · 36 of its ownK050332 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005
- Descendant · 2 generations on · 17 of its ownK070894 Tephaflex Surgical MeshTepha, Inc. · 2007
- Descendant · 2 generations on · 13 of its ownK061473 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 12 of its ownK063648 Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007
- Descendant · 3 generations on · 10 of its ownK072190 Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K050332Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005 · cites it directly36descendants
- K070894Tephaflex Surgical MeshTepha, Inc. · 2007 · 2 generations on17descendants
- K061473Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2006 · 2 generations on13descendants
- K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007 · 3 generations on12descendants
- K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031225 | Timesh Also Known as Timesh-TC, Models 6000001 & 6000004 | Gfe Medizintechnik GmbH | 2003 | — |
| +1 | K050332 | Surgi-Wrap Mast Bioresorbable Sheet | Mast Biosurgery USA, Inc. | 2005 | — |
| +2 | K070894 | Tephaflex Surgical Mesh | Tepha, Inc. | 2007 | — |
| +2 | K061473 | Surgi-Wrap Mast Bioresorbable Sheet | Mast Biosurgery USA, Inc. | 2006 | 1 |
| +3 | K063648 | Surgi-Wrap Mast Tendon Sheet | Mast Biosurgery USA, Inc. | 2007 | — |
| +3 | K072190 | Ortho-Wrap Bioresorbable Sheet | Mast Biosurgery | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K001122 | FDA’s K001122 is Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
| Kept off the family tree | K905655 | FDA’s K905655 is Nonabsorbable Polypropylene Surgical Mesh Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1990 |
| Kept off the family tree | K915526 | FDA’s K915526 is Coated Surgipro (TM) Polypropylene Surgical Mesh Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1992 |
What descends from it? (42)
See all 423 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K050332 (Mast Biosurgery USA, Inc., 2005) has gone furthest, with 36 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?
The TIMESH is intended for the reinforcement of tissue during surgical repair. Specifically, the TiIMESH is indicated for laparoscopic and open surgery for the repair of direct inguinal hemias, indirect inguinal hernias, femoral hemias, umbilical hernias, incisional hernias, parietal reinforcement of tissues and abdominal wall 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/K031225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031225: Timesh Also Known as Timesh-TC, Models 6000001 & 6000004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031225
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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