Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KHJ — Predicate Candidate Screening
33 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
268 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); B | Cook Biotech Incorporated | 2024-05-24 | 268 | 1 |
| K161000 | Biodesign Otologic Repair Graft | Cook Biotech Incorporated | 2016-05-11 | 30 | 0 |
| K150594 | Biodesign Otologic Repair Graft | Cook Biotech Incorprated | 2015-09-16 | 191 | 0 |
| K132198 | ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI | Ceremed , Inc. | 2013-09-12 | 58 | 0 |
| K121360 | BIODESIGN ENT REPAIR GRAFT | Cook Biotech Incorprated | 2013-02-27 | 296 | 0 |
| K122561 | ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN | Ceremed , Inc. | 2012-11-27 | 97 | 0 |
| K120220 | ADAPTAIN SOLUBLE IMPLANT MATERIAL | Ceremed , Inc. | 2012-06-06 | 133 | 0 |
| K103047 | CERETENE SOLUBLE IMPLANT MATERIAL | Ceremed , Inc. | 2011-01-05 | 82 | 0 |
| K080022 | GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP | Vascular Solutions, Inc. | 2008-12-09 | 341 | 0 |
| K082245 | AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AO | Ceremed , Inc. | 2008-09-18 | 42 | 0 |
| K081531 | AOC SOLUBLE IMPLANT MATERIAL | Ceremed , Inc. | 2008-07-18 | 46 | 0 |
| K070093 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, | Ceremed , Inc. | 2007-01-24 | 14 | 0 |
| K062280 | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE A | Ceremed , Inc. | 2006-12-11 | 126 | 0 |
| K060561 | CLEARADEX GEL | Cambridgemed | 2006-05-30 | 88 | 0 |
| K060878 | GELITA-SPON ABSORBABLE GELATIN SPONGE, USP | Curamedical, BV | 2006-04-13 | 13 | 0 |
| K051487 | DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE | Doctor'S Research Group, Inc. | 2005-12-22 | 199 | 0 |
| K051911 | GELITA-SPON | Curamedical, BV | 2005-12-06 | 145 | 0 |
| K043035 | SEPRAGEL ENT BIORESORBABLE PACKING/STENT | Genzyme Corporation | 2005-07-11 | 250 | 0 |
| K033796 | KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS | Heinz Kurz GmbH Medizintechnik | 2004-01-30 | 56 | 0 |
| K013243 | COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0 | Bioform, Inc. | 2002-01-09 | 103 | 1 |
| K003855 | HYALOMATRIX CO | Fidia Advanced Biopolymers Srl | 2001-07-03 | 202 | 0 |
| K002972 | MEROGEL CONTROL GEL ENT SURGICAL DRESSING | Medtronic Xomed | 2000-12-15 | 84 | 0 |
| K001148 | MEROGEL OTOLOGIC PACK | Xomed, Inc. | 2000-06-03 | 54 | 0 |
| K991324 | TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FE | Heinz Kurz | 1999-05-18 | 29 | 0 |
| K982870 | EPIFILM OTOLOGIC LAMINA | Xomed, Inc. | 1998-11-03 | 81 | 0 |
| K982294 | XOMED SILICONE PRE-FORM BLOCKS | Xomed, Inc. | 1998-09-18 | 80 | 0 |
| K972700 | EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT C | Exmoor Plastics , Ltd. | 1998-07-16 | 393 | 0 |
| K974311 | VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT | Gyrus Ent LLC | 1998-03-04 | 107 | 0 |
| K970910 | XOMED SILICONE BLOCK/STRIP | Xomed, Inc. | 1997-05-02 | 51 | 0 |
| K964484 | KARTUSH TM PATCHER | Xomed, Inc. | 1997-01-24 | 78 | 0 |
| K953013 | MEROCEL REINFORCED SILICONE SHEETS | Merocel Corp. | 1995-08-29 | 61 | 0 |
| K932176 | BIOSIL MEDICAL GRADE SILICONE SHEETING | Bioplexus Corp. | 1993-12-02 | 211 | 0 |
| K911503 | EXMOOR SILICONE RUBBER SHEET | Exmoor Plastics , Ltd. | 1991-11-19 | 230 | 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