Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Unknown — Predicate Candidate Screening
3,119 FDA 510(k) clearances under this medical specialty; the 50 most recent screened below.
131 daysmedian FDA review time
322 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260120 | NaturaJel™ Oral Wound Care Kit | HCS Innovation, LLC | 2026-08-05 | 202 | 0 |
| K261504 | PuraStat-RM | 3-D Matrix, Inc. | 2026-08-03 | 89 | 0 |
| K261448 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC | 2026-07-30 | 90 | 0 |
| K251908 | Emanate Tray | Emanate Biomedical | 2026-07-29 | 404 | 0 |
| K260596 | Collagen Wound Powder | Ventris Medical | 2026-07-02 | 128 | 0 |
| K260790 | G-Series Grind Guard | ASESSO HEALTH, Inc. | 2026-06-25 | 106 | 0 |
| K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | 2026-06-24 | 86 | 0 |
| K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | 2026-06-24 | 366 | 0 |
| K260669 | Endoform Dermal Template | Aroa Biosurgery , Ltd. | 2026-06-24 | 114 | 0 |
| K253521 | ECMT-100 WMD | Ecm Therapeutics, Inc. | 2026-06-18 | 217 | 0 |
| K261638 | Bonvadis® | Oneness Biotech Co., Ltd. | 2026-06-17 | 30 | 0 |
| K260126 | Curajel™ Oral Gel | USpharma, Ltd. | 2026-06-15 | 151 | 0 |
| K261209 | Ion-L | SurGenTec, LLC | 2026-06-11 | 59 | 0 |
| K253204 | Catalyze | BioTissue Holdings, Inc. | 2026-06-05 | 252 | 0 |
| K253974 | Roosin Collagen Dressing | Roosin Medical Co., Ltd. | 2026-06-03 | 174 | 0 |
| K261439 | Permatage Flowable, Settable Hemostatic Bone Paste | Orthocon, Inc. | 2026-06-03 | 34 | 0 |
| K254034 | Roosin Collagen Powder | Roosin Medical Co., Ltd. | 2026-06-03 | 169 | 0 |
| K253816 | MuCover (proposed name) Oral Wound Dressing | MoleculeX Co., Ltd. | 2026-05-21 | 174 | 0 |
| K261224 | MatriDerm | Medskin Solutions Dr. Suwelack AG | 2026-05-14 | 30 | 0 |
| K253676 | CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PC | Providence Medical Technology, Inc. | 2026-05-14 | 174 | 0 |
| K254073 | StatSeal Disc | Merit Medical Systems, Inc. | 2026-05-13 | 146 | 0 |
| K253017 | BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. | 2026-04-30 | 223 | 0 |
| K260020 | Redermo Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-04-16 | 101 | 0 |
| K252485 | ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (La | 1987 Media Limited | 2026-04-10 | 246 | 0 |
| K252224 | Apex Locator (FindPex) | Changzhou Sifary Medical Technology Co., Ltd. | 2026-04-08 | 266 | 0 |
| K254191 | IWD-Gel™ | InnovaCorium, Inc. | 2026-04-07 | 105 | 0 |
| K254239 | CyClean Cord | SS GLOBAL | 2026-03-27 | 88 | 0 |
| K252023 | MiraChlor Antimicrobial Wound Solution | Letus Corporation | 2026-03-25 | 268 | 0 |
| K260532 | Derma-Gide | Geistlich Pharma AG | 2026-03-19 | 30 | 0 |
| K253432 | DiversiVy™ Facet Screw System | Vy Spine, LLC | 2026-03-19 | 169 | 0 |
| K251999 | Promogran Prisma™ Collagen Matrix with ORC and Silver | Solventum Germany GmbH | 2026-03-13 | 259 | 0 |
| K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 | 254 | 0 |
| K253798 | UltraPrint-Dental Hard Splint UV | Guangzhou Heygears IMC., Inc. | 2026-03-02 | 94 | 0 |
| K253797 | One-Stop | Mediclus Co., Ltd. | 2026-02-27 | 91 | 0 |
| K253778 | Allday Moisturizing Rinse | Elevate Oral Care | 2026-02-27 | 93 | 0 |
| K253641 | Owl Night Guard | Owl Dental Lab, Inc. | 2026-02-26 | 99 | 0 |
| K251700 | Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG1004 | Speciality Fibres and Materials Limited | 2026-02-26 | 269 | 0 |
| K260218 | LacertaMatrix | Lacerta Life Sciences | 2026-02-19 | 27 | 0 |
| K252751 | Earflo (EF001) | Earflo, Inc. | 2026-02-10 | 165 | 0 |
| K253140 | CollOvine™ Wound Powder | Ovigenex, LLC | 2026-02-10 | 138 | 0 |
| K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-02-02 | 255 | 0 |
| K252568 | New Day Skin Spray | Silk Holdings, Inc. | 2026-01-23 | 162 | 0 |
| K251323 | Device 104 Particulate | Geistlich Pharma AG | 2026-01-22 | 268 | 0 |
| K251714 | Ion-C | SurGenTec, LLC | 2026-01-16 | 227 | 0 |
| K251900 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2026-01-16 | 210 | 0 |
| K254126 | Natrelle 133S Tissue Expanders | AbbVie | 2026-01-16 | 28 | 0 |
| K250890 | SBC1 Cream | Sioxmed, LLC | 2026-01-12 | 293 | 0 |
| K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | 2026-01-08 | 132 | 0 |
| K253923 | PuraStat | 3-D Matrix Europe SAS | 2026-01-07 | 30 | 0 |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | 2026-01-05 | 210 | 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