510(k) · Cleared
Recalled · Class II · 2017ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atrium Medical Corporation · FTL Mesh, Surgical, Polymeric
Cleared on Aug 27, 2015 as substantially equivalent to K930669 (Atrium Medical Corp., 1993) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1993. It has been recalled once.
- Decided
- Aug 27, 2015
- Review
- 90 days
- Class
- Class II
- Product code
- FTL
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930669 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK930669 Atrium Polypropylene MeshAtrium Medical Corp. · 1993
- This deviceK151437 ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh PlugAtrium Medical Corporation · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930669 | Atrium Polypropylene Mesh | Atrium Medical Corp. | 1993 | — |
| 0 (this device) | K151437 | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug | Atrium Medical Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (2)
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 |
|---|---|---|---|
| * | K930669 | Atrium Polypropylene MeshSummary page 4…icate Devices: ProLite and ProLite Ultra Mesh, and ProLoop Mesh Plug Mesh, Surgical, Polymeric Surgical Mesh 21 CFR 878.3300, Class II FTL General & Plastic Surgery K930669 Atrium ProLite™ Mesh K002093 Atrium ProLite Ultra™ Mesh K930669 Atrium ProLoop™™ Mesh Plug K151437 Page 2 of 2… | 1993 |
| * | K002093 | Atrium Lite MeshSummary page 4…roLite Ultra Mesh, and ProLoop Mesh Plug Mesh, Surgical, Polymeric Surgical Mesh 21 CFR 878.3300, Class II FTL General & Plastic Surgery K930669 Atrium ProLite™ Mesh K002093 Atrium ProLite Ultra™ Mesh K930669 Atrium ProLoop™™ Mesh Plug K151437 Page 2 of 2 Device Description: ProLite™… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 22, 2017 | Class II | Z-0712-2018 | Under Investigation by firm | An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch of packages labeled with product code… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K930669.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
ProLite Mesh and ProLite Ultra Mesh are intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds, and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
ProLoop Mesh Plug is intended for use in soft tissue deficiencies including hernia repair and traumatic or surgical wounds requiring reinforcement with a non-absorbable supportive material.
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/K151437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151437: ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151437
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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