FDA product code · General, Plastic Surgery
FTLMesh, Surgical, Polymeric
Product code FTL covers Mesh, Surgical, Polymeric, a Class II device regulated under 21 CFR 878.3300. FDA has cleared 336 devices in this code, 2 of them in the last 12 months. Median review time across the 336 most recent decisions is 89 days. openFDA lists 73 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 878.3300
- Review panel
- General, Plastic Surgery
- Clearances
- 336
What is happening in FTL right now?
FTL (Mesh, Surgical, Polymeric) has two findings, most consequential first. 1 first-time filer in the last 12 months, Medtronic - Sofradim Production (K253125). The code is crowded, scoring 69 of 100 — 113 companies hold a clearance here and 2 arrived in the last 12 months (FTL:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K253125 |
| Crowding | Context | FTL:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in FTL?
FDA has cleared 336 devices under product code FTL since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253956 | ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) | Sofradim Production | |
| K253125 | Parietene Flat Sheet Mesh | Medtronic - Sofradim Production | |
| K251955 | Onflex Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | |
| K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped | Davol, Inc. | |
| K250869 | Parietene Macroporous Mesh (PPM5050 ) | Sofradim Production | |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | Davol, Inc. | |
| K243315 | ProGrip Self-Gripping Polypropylene Mesh | Sofradim Production | |
| K241250 | 3DMax Light Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | |
| K232373 | Progrip Self-Gripping Polypropylene Mesh | Sofradim Production | |
| K233402 | Bard 3DMax Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. |
How long does FDA review take for FTL?
The median FDA review time for FTL is 89 days, measured across the 336 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in FTL?
openFDA lists 73 recall records against product code FTL. A recall record covers one firm's corrective action and may span many device lots.
Z-2513-2024Open, ClassifiedW. L. Gore & Associates, Inc.
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
Z-2241-2023Open, ClassifiedDavol, Inc.
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Z-2242-2023Open, ClassifiedDavol, Inc.
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Z-2243-2023Open, ClassifiedDavol, Inc.
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Z-2244-2023Open, ClassifiedDavol, Inc.
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Showing the 5 most recently initiated of 73. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for FTL?
MAUDE holds 18,879 adverse-event reports naming product code FTL, 2,001 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in FTL unusual?
Every month with enough history behind it falls inside FTL's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 559 | Insufficient history | No expected range — too little history | |
| 693 | Insufficient history | No expected range — too little history | |
| 767 | Insufficient history | No expected range — too little history | |
| 691 | Insufficient history | No expected range — too little history | |
| 612 | Insufficient history | No expected range — too little history | |
| 741 | Insufficient history | No expected range — too little history | |
| 559 | Insufficient history | No expected range — too little history | |
| 513 | Insufficient history | No expected range — too little history | |
| 534 | Insufficient history | No expected range — too little history | |
| 608 | Insufficient history | No expected range — too little history | |
| 795 | Insufficient history | No expected range — too little history | |
| 900 | Insufficient history | No expected range — too little history | |
| 831 | Insufficient history | No expected range — too little history | |
| 1,061 | Insufficient history | No expected range — too little history | |
| 468 | Insufficient history | No expected range — too little history | |
| 1,001 | Insufficient history | No expected range — too little history | |
| 1,072 | Insufficient history | No expected range — too little history | |
| 476 | Insufficient history | No expected range — too little history | |
| 368 | Insufficient history | No expected range — too little history | |
| 413 | Insufficient history | No expected range — too little history | |
| 578 | Insufficient history | No expected range — too little history | |
| 222 | 39–1,013 | Within expected (39–1,013) | |
| 192 | 0–862 | Within expected (0–862) | |
| 370 | 0–945 | Within expected (0–945) | |
| 359 | 0–954 | Within expected (0–954) | |
| 401 | 0–870 | Within expected (0–870) | |
| 352 | 0–822 | Within expected (0–822) | |
| 339 | 0–1,296 | Within expected (0–1,296) | |
| 320 | 0–846 | Within expected (0–846) | |
| 204 | 144–611 | Within expected (144–611) | |
| 237 | 73–570 | Within expected (73–570) | |
| 187 | 30–506 | Within expected (30–506) | |
| 229 | 0–546 | Within expected (0–546) | |
| 305 | 38–549 | Within expected (38–549) | |
| 326 | 35–468 | Within expected (35–468) | |
| 310 | 68–537 | Within expected (68–537) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in FTL.
Who has entered FTL in the last year?
One company filed in FTL for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Medtronic - Sofradim Production | K253125 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in FTL?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in FTL?
Across the 336 most recent decisions, these applicants filed most often in FTL.
| Applicant | Recent clearances |
|---|---|
| Sofradim Production | 36 |
| W. L. Gore & Associates, Inc. | 36 |
| C.R. Bard, Inc. | 25 |
| ETHICON, Inc. | 24 |
| Atrium Medical Corp. | 11 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
4 companies in FTL file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| W. L. Gore & Associates, Inc. | 37 | 2 |
| C.R. Bard, Inc. | 26 | 2 |
| ETHICON, INC. | 25 | 2 |
| Atrium Medical Corporation | 14 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch FTL
Get an email the morning anything changes in FTL — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.