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 Mar 30, 2020 as substantially equivalent to K052155 (C.R. Bard, Inc., 2005) after a 138-day review. Its family tree reaches back 1 generation to 2005. 3 later devices descend from it.
- Decided
- Mar 30, 2020
- Review
- 138 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052155 (2005). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK052155 Bard Large Pore Soft Mesh and Soft Mesh PreshapedC.R. Bard, Inc. · 2005 · Recalled
- This deviceK193144 T-Line Hernia MeshDeep Blue Medical Advances, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK221556 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 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052155 | Bard Large Pore Soft Mesh and Soft Mesh Preshaped | C.R. Bard, Inc. | 2005 | 1 |
| 0 (this device) | K193144 | T-Line Hernia Mesh | Deep Blue Medical Advances, Inc. | 2020 | — |
| +1 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K052155 | Bard Large Pore Soft Mesh and Soft Mesh PreshapedSummary page 4…PRODUCT CODE(S): FTL CFR CLASSIFICATION AND NAME: 21 CFR§878.3300 Mesh, Surgical, Polymeric PREDICATE DEVICE K052155 Bard Soft Mesh Reference Device: K133356 Ethicon, Inc. PROLENE Polypropylene Suture DEVICE The T-… | 2005 |
| † | K133356 | Prolene Polypropylene Nonabsorbable Suture | 2013 |
What descends from it? (3)
3 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?
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
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 approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193144 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193144: T-Line Hernia Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193144
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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