510(k) · Cleared

Cleared

T-Line® Hernia Mesh

K232924510(k) SpecialCleared Oct 18, 202329-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Deep Blue Medical Advances, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Oct 18, 2023 as substantially equivalent to K230227 (Deep Blue Medical Advances, Inc., 2023) and 2 other predicates after a 29-day review. Its family tree reaches back 4 generations to 2005.

Decided: Oct 18, 2023
Review: 29 days
Class: Class II
Product code: FTL
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K052155 (2005). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK052155 Bard Large Pore Soft Mesh and Soft Mesh PreshapedC.R. Bard, Inc. · 2005 · Recalled
3 generations backK193144 T-Line Hernia MeshDeep Blue Medical Advances, Inc. · 2020
2 generations backK221556 T-Line Hernia MeshDeep Blue Medical Advances, Inc. · 2022
1 generation backK230227 T-Line Hernia MeshDeep Blue Medical Advances, Inc. · 2023
This deviceK232924 T-Line® Hernia MeshDeep Blue Medical Advances, Inc. · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K052155	Bard Large Pore Soft Mesh and Soft Mesh Preshaped	C.R. Bard, Inc.	2005	1
−3	K193144	T-Line Hernia Mesh	Deep Blue Medical Advances, Inc.	2020	—
−2	K221556	T-Line Hernia Mesh	Deep Blue Medical Advances, Inc.	2022	—
−1	K230227	T-Line Hernia Mesh	Deep Blue Medical Advances, Inc.	2023	—
0 (this device)	K232924	T-Line® Hernia Mesh	Deep Blue Medical Advances, Inc.	2023	—

FIG. 1 — Lineage of K232924, 2005–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K230227	T-Line Hernia Mesh Summary page 5 …n and Name: 21 CFR§878.3300 Mesh, Surgical, Polymeric PREDICATE DEVICE T-Line Hernia Mesh (K230227, K221556, K193144) Product Code(s): FTL CFR Classification and…	Deep Blue Medical Advances, Inc.	2023	—
*	K221556	T-Line Hernia Mesh Summary page 5 …e: 21 CFR§878.3300 Mesh, Surgical, Polymeric PREDICATE DEVICE T-Line Hernia Mesh (K230227, K221556, K193144) Product Code(s): FTL CFR Classification and Name:…	Deep Blue Medical Advances, Inc.	2022	—
*	K193144	T-Line Hernia Mesh Summary page 5 …21 CFR§878.3300 Mesh, Surgical, Polymeric PREDICATE DEVICE T-Line Hernia Mesh (K230227, K221556, K193144) Product Code(s): FTL CFR Classification and Name: 21 CFR§8…	Deep Blue Medical Advances, Inc.	2020	—

What descends from it?

No later submission names this one as a predicate yet.

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 2 companies; a new generation was cleared every 2.7 years on median.
1 of the 4 ancestors has a recall of any class.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · FTL

6in 2025

2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007high 213 (2012) · low 29 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTL

1in 2020

2007high 12 (2010) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTL

3,487in 2025

2007high 26,519 (2013) · low 1,569 (2008)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 sub lay approach in adults (greater than 21 years of age).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K232924 · printed Nov 6, 2026

Cite this page

510(k) Report. “K232924: 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/K232924

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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