Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NPK — Predicate Candidate Screening
31 FDA 510(k) clearances under this product code; the 50 most recent screened below.
160 daysmedian FDA review time
529 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221851 | Lumina-PTFE Titanium | Criteria Industria E Comercio DE Produtos Medicinais | 2023-12-08 | 529 | 0 |
| K222549 | OpenTex | Purgo Biologics, Inc. | 2023-05-11 | 261 | 0 |
| K211554 | InnoGenic Non-resorbable Membrane | Cowellmedi Co., Ltd. | 2023-02-24 | 646 | 0 |
| K210797 | Bio-MEM Ti Reinforced Membrane | B&Medi Co., Ltd. | 2022-08-18 | 520 | 0 |
| K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | Osteogenics Biomedical, Inc. | 2021-01-23 | 267 | 0 |
| K171774 | RPM Reinforced PTFE Mesh | Osteogenics Biomedical, Inc. | 2017-10-19 | 127 | 0 |
| K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg | Salvin Dental Specialties | 2016-09-08 | 199 | 0 |
| K151344 | Cytoflex Tefguard Ti-Enforced Membrane | Unicare Biomedical, Inc. | 2015-11-19 | 184 | 0 |
| K143327 | Neoss Ti Reinforced Membrane | Neoss, Ltd. | 2015-04-13 | 144 | 0 |
| K132325 | GUIDOR BIORESORBABLE MATRIX BARRIER | Sunstar Americas, Inc. | 2013-10-29 | 95 | 0 |
| K102184 | MEDPOR CONTAIN CAN IMPLANT | Porex Surgical, Inc. | 2011-01-07 | 158 | 0 |
| K101956 | STRAUMANN MEMBRAGEL | Straumann USA (On Behalf of Institut Straumann Ag) | 2010-12-16 | 157 | 0 |
| K091120 | MEDPOR CONTAIN IMPLANT | Porex Surgical, Inc. | 2010-03-19 | 336 | 0 |
| K082111 | STRAUMANN MEMBRAGEL | Institut Straumann AG | 2009-05-22 | 298 | 0 |
| K051267 | GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERA | W. L. Gore & Associates, Inc. | 2005-06-15 | 30 | 0 |
| K033074 | INION GTR BIODEGRADABLE MEMBRANE SYSTEM | Inion , Ltd. | 2004-03-31 | 184 | 0 |
| K990363 | BIOMESH BIODEGRADABLE GTR BARRIER | Samyang Corp. | 1999-04-09 | 63 | 0 |
| K982865 | ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARR | Atrix Laboratories, Inc. | 1998-09-08 | 26 | 1 |
| K974752 | IMTEC/BIOBARRIER MEMBRANE | Imtec Corp. | 1998-03-03 | 74 | 0 |
| K972240 | IMTEC BIOBARRIER MEMBRANE | Imtec Corp. | 1997-08-26 | 71 | 0 |
| K960724 | BIO-GIDE RESORBABLE BILAYER MEMBRANE | Geistlich-Pharma | 1997-06-11 | 475 | 0 |
| K965205 | TEFGEN - LS | American Custom Medical, Inc. | 1997-04-30 | 125 | 0 |
| K964656 | TEFGEN GUIDED TISSUE MEMBRANE | American Custom Medical, Inc. | 1997-02-10 | 82 | 0 |
| K955646 | VICRYL PERIDONTAL MESH | ETHICON, Inc. | 1996-05-20 | 160 | 0 |
| K960292 | GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURA | W. L. Gore & Associates, Inc. | 1996-04-15 | 84 | 0 |
| K955838 | ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR) | Atrix Laboratories, Inc. | 1996-03-21 | 90 | 0 |
| K935137 | TEFGEN-FD | American Custom Medical, Inc. | 1994-08-15 | 291 | 1 |
| K922627 | GORE-TEX REGENERATIVE MATERIAL | W. L. Gore & Associates, Inc. | 1994-06-10 | 737 | 0 |
| K933541 | GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGUR | W. L. Gore & Associates, Inc. | 1993-11-30 | 132 | 0 |
| K912724 | GUIDOR(TM) | Procordia Oratech AB | 1993-05-13 | 695 | 0 |
| K854299 | GORE-TEX PERIODONTAL MATERIAL | W. L. Gore & Associates, Inc. | 1986-05-19 | 206 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda