510(k) · Cleared
ClearedFreedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended Disk
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insightra Medical · FTL Mesh, Surgical, Polymeric
Cleared on Jun 10, 2014 as substantially equivalent to K113552 (Insightra Medical, 2012) and 2 other predicates after a 57-day review. Its family tree reaches back 2 generations to 1992.
- Decided
- Jun 10, 2014
- Review
- 57 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K922916 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922916 | Bard Marlex Mesh Dart | C.R. Bard, Inc. | 1992 | — |
| −1 | K113552 | Freedom Inguinal Hernia Implant | Insightra Medical | 2012 | — |
| 0 (this device) | K140967 | Freedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended Disk | Insightra Medical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 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 |
|---|---|---|---|
| * | K113552 | Freedom Inguinal Hernia ImplantSummary page 1…Surgical Polymeric Mesh Classification Code: Class 11,§ 878.3300, Product Code FTL Predicate Devices: " Freedom Inguinal Hernia Implant, K1 13552, FDA cleared on 8/23/2012 * Ethicon Prolene Hernia System, K984220, FDA cleared on 2/23/1999 * Bard Perfix Plug, K9… | 2012 |
| * | K984220 | Modification of Prolene (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical…Summary page 1…11,§ 878.3300, Product Code FTL Predicate Devices: " Freedom Inguinal Hernia Implant, K1 13552, FDA cleared on 8/23/2012 * Ethicon Prolene Hernia System, K984220, FDA cleared on 2/23/1999 * Bard Perfix Plug, K922916, FDA cleared on 8/24/1 992 Device Description: The Freeddm… | 1999 |
| * | K922916 | Bard Marlex Mesh DartSummary page 1…Freedom Inguinal Hernia Implant, K1 13552, FDA cleared on 8/23/2012 * Ethicon Prolene Hernia System, K984220, FDA cleared on 2/23/1999 * Bard Perfix Plug, K922916, FDA cleared on 8/24/1 992 Device Description: The Freeddm Inguinal Hernia Implant is used to plug or patch a hernia… | 1992 |
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 22 years and passes through 2 companies; a new generation was cleared every 20.0 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Freedom Inguinal Hernia Implant is intended to be implanted to reinforce soft tissues where weakness for open repair of inguinal hernias exist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140967 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140967: Freedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended Disk.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140967
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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