510(k) · Cleared
ClearedT-Line Hernia Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deep Blue Medical Advances, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Nov 28, 2022 as substantially equivalent to K193144 (Deep Blue Medical Advances, Inc., 2020) after a 181-day review. Its family tree reaches back 2 generations to 2005. 2 later devices descend from it.
- Decided
- Nov 28, 2022
- Review
- 181 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K052155 (2005). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK052155 Bard Large Pore Soft Mesh and Soft Mesh PreshapedC.R. Bard, Inc. · 2005 · Recalled
- 1 generation backK193144 T-Line Hernia MeshDeep Blue Medical Advances, Inc. · 2020
- This deviceK221556 T-Line Hernia MeshDeep Blue Medical Advances, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK230227 T-Line Hernia MeshDeep Blue Medical Advances, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK232924 T-Line® Hernia MeshDeep Blue Medical Advances, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K052155 | Bard Large Pore Soft Mesh and Soft Mesh Preshaped | C.R. Bard, Inc. | 2005 | 1 |
| −1 | K193144 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2020 | — |
| 0 (this device) | K221556 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2022 | — |
| +1 | K230227 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2023 | — |
| +1 | K232924 | T-Line® Hernia Mesh | Deep Blue Medical Advances, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (1)
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 |
|---|---|---|---|
| * | K193144 | T-Line Hernia MeshSummary page 4…shProduct Code(S): FTL CFR Classification and Name: 21 CFR§878.3300 Mesh, Surgical, Polymeric PREDICATE DEVICE K193144 T-Line® Hernia Mesh Reference Devices: K052155 Bard Soft Mesh; K133356 Ethicon, Inc.… | 2020 |
| † | K052155 | Bard Large Pore Soft Mesh and Soft Mesh Preshaped | 2005 |
| † | K133356 | Prolene Polypropylene Nonabsorbable Suture | 2013 |
What descends from it? (2)
2 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?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 14.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K230227 (Deep Blue Medical Advances, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K193144.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 T-Line Hernia Mesh is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay or sublay approach in adults (greater than 21 years of age).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221556: T-Line Hernia Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221556
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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