Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MDA — Predicate Candidate Screening
81 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
218 days90th percentile
81clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112131 | NEODYNE DRESSING | Neodyne Biosciences, Inc. | 2011-09-29 | 65 | 0 |
| K111733 | CORELEADER SCAR-DIMMER | Coreleader Biotech Co., Ltd. | 2011-09-22 | 93 | 0 |
| K083718 | BEAU RX SCAR CARE GEL | Beau RX Solutions, LLC | 2009-01-26 | 42 | 0 |
| K053481 | KELO-COTE SPRAY | Advanced Bio-Technologies, Inc. | 2006-04-14 | 121 | 0 |
| K041704 | NEWGEL AND NEWGEL PLUS E | Newmedical Technology, Inc. | 2005-10-17 | 481 | 0 |
| K040307 | HANSON SCAR ADE | Hanson Medical, Inc. | 2004-08-12 | 185 | 0 |
| K024057 | CURAD SCAR THERAPY | Beiersdorf, Inc. | 2003-06-18 | 191 | 0 |
| K024160 | NEOSPORIN SCAR SOLUTION | Warner-Lambert Co. | 2003-03-17 | 90 | 0 |
| K023678 | DIMISIL SCAR GEL | Aesthetic and Reconstructive Technologies, Inc. | 2003-01-23 | 83 | 0 |
| K023136 | OLEEVA FABRIC | Bio Med Sciences, Inc. | 2002-10-16 | 26 | 0 |
| K014036 | MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL | Medtrade Products , Ltd. | 2002-02-14 | 69 | 0 |
| K013732 | GELZONE | Implantech Associates, Inc. | 2002-02-07 | 90 | 0 |
| K012419 | CONFORM SHEETING, MODEL IGEL | Implantech Associates, Inc. | 2001-10-24 | 86 | 0 |
| K010675 | ENSIL FABRIC | Gottfried Medical, Inc. | 2001-05-30 | 85 | 0 |
| K010245 | ACTIVHEAL SCAR MANAGEMENT DRESSING | Advanced Medical Solutions, Ltd. | 2001-04-25 | 90 | 0 |
| K003979 | MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD | Medtrade Products , Ltd. | 2001-03-19 | 87 | 0 |
| K003948 | EPI-DERM SILICONE GEL SHEETING | Biodermis Corp. | 2001-01-29 | 39 | 0 |
| K002488 | KELO-COTE TOPICAL GEL | Advanced Bio-Technologies, Inc. | 2001-01-05 | 144 | 0 |
| K002109 | OLEEVA FOAM | Bio Med Sciences, Inc. | 2000-08-31 | 50 | 0 |
| K001608 | BLAINE SCARCARE PATCH | Blaine Labs, Inc. | 2000-07-25 | 62 | 0 |
| K992522 | SPECTRUM DESIGNS SPECTRAGEL | Spectrum Designs, Inc. | 1999-10-26 | 90 | 0 |
| K991970 | SCAREASE SHEETS & SCAREASE GEL | Pillar Surgical | 1999-10-25 | 136 | 0 |
| K991312 | SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING | Library Medical, Inc. | 1999-08-20 | 126 | 0 |
| K990651 | SKIN 2 FORTE SILICONE SHEETING | United Hospital Technologies, Inc. | 1999-08-13 | 165 | 0 |
| K984029 | SILGEL STC-S | Nagor , Ltd. | 1999-08-05 | 266 | 0 |
| K991968 | CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL. | Smith & Nephew, Inc. | 1999-07-30 | 49 | 0 |
| K992146 | SCARAID SILICONE GEL SHEETING | Biodermis Corp. | 1999-07-30 | 36 | 0 |
| K991957 | CICACARE MANAGEMENT FOR SCARS | Smith & Nephew, Inc. | 1999-07-20 | 40 | 0 |
| K991478 | TENDER TOUCH SILICONE GEL PADS | Capital Marketing Technologies, Inc. | 1999-06-21 | 54 | 0 |
| K991630 | ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEE | Advanced Medical Solutions Group Plc | 1999-06-11 | 31 | 0 |
| K991604 | EPI-FOAM SILICONE SHEETING | Biodermis Corp. | 1999-06-09 | 30 | 0 |
| K981353 | AVOGEL | Avocet Polymer Technologies, Inc. | 1999-06-01 | 413 | 0 |
| K984213 | NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS | Capital Marketing Technologies, Inc. | 1999-04-14 | 141 | 0 |
| K984115 | SCAREASE & SCAREASE ADHESIVE GEL | Scarease, Inc. | 1999-02-12 | 87 | 0 |
| K982036 | SILON SCAR STRIPS | Bio Med Sciences, Inc. | 1998-08-06 | 57 | 0 |
| K982051 | KELOCATE SHEETING | Allied Biomedical Corp. | 1998-08-05 | 55 | 0 |
| K981902 | SPENCO SILICONE GEL SHEET | Spenco Medical Corp. | 1998-06-25 | 24 | 0 |
| K981387 | EVANESCE SCAR MANAGEMENT SYSTEM | Medical Scientific, Inc. | 1998-06-10 | 55 | 0 |
| K980563 | SKAR-KARE SHEET | Life Medical Sciences, Inc. | 1998-05-20 | 96 | 0 |
| K974380 | REJUVENESS | Rejuveness Pharamceuticals, Inc. | 1998-04-03 | 164 | 0 |
| K974172 | SILGEL TOPICAL GEL SHEET | Nagor , Ltd. | 1998-03-30 | 145 | 0 |
| K974143 | KMC NEWSKIN | Kmc Intl. Co. | 1998-03-27 | 144 | 0 |
| K974354 | MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE | Sca Molnlycke | 1998-03-05 | 106 | 0 |
| K973271 | SKAR-KARE | Target Health, Inc. | 1997-11-19 | 78 | 0 |
| K973572 | KELOCOTE SCAR GEL AND KELOCOTE LASER GEL | Hanson Medical, Inc. | 1997-10-21 | 32 | 0 |
| K972597 | PMT NEW BEGINNINGS GELSHAPES & AMEND | Pmt Corp. | 1997-10-01 | 82 | 0 |
| K971916 | MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL | Medical Z, S.A. | 1997-07-29 | 67 | 0 |
| K971009 | SCAR CARE | Target Health, Inc. | 1997-07-29 | 131 | 0 |
| K971482 | DEGANIA SILICONE SIL-K | Degania Silicone , Ltd. | 1997-06-24 | 64 | 0 |
| K971468 | SCAR HEAL | Specialty Systems, Inc. | 1997-06-10 | 49 | 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