510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K172129 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K172084 | Delta III Lithotripter | Dornier Medtech America, Inc. | LNS | Class II | |
| K171881 | JAZZ Passer Band | Implanet | OWI | Class II | |
| K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set | C.R. Bard Inc | PTI | Class II | |
| K171707 | Ga-B, Ga-C, Ga-E, Ga-I, Ga-S, Ga-W3a, Ga-F3a, Ga-Il, Ga-Sl, Ga-W3b, Ga-F1a | Gowoonsesang Cosmetics Co., Ltd. | GEI | Class II | |
| K171451 | Ahmed Glaucoma Valve Model FP8 | New World Medical, Inc. | KYF | Class II | |
| K171444 | YUKON OCT Spinal System | K2M, Inc | NKG | Class II | |
| K171389 | EVOLUTION Revision CCK System | Microport Orthopedics Inc. | JWH | Class II | |
| K170939 | Supplemental Instrument Trays | Nuvasive Specialized Orthopedics, Incorporated | KCT | Class II | |
| K170888 | Renovis S141 Lumbar Interbody Fusion System | Renovis Surgical Technologies, LLC | MAX | Class II | |
| K170845 | MiniMAX | Medacta International SA | LZO | Class II | |
| K170588 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II | |
| K170529 | Delight, Delight ortho, B&Lite S | Dentall, Inc. | EBZ | Class II | |
| K170272 | TruMatch CMF Titanium 3D Printed Implant System | Materialise N.V. | JEY | Class II | |
| K163446 | AxoGen Nerve Cap | Axogen Corporation | JXI | Class II | |
| K163390 | iC-GPC Assay TM for use on the iC-SystemTM | Icubate, Inc. | PAM | Class II | |
| K163225 | AFIAS iFOB with AFIAS-50 | Immunostics, Inc. | OOX | Class II | |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA | Immco Diagnostics, Inc. | DBM | Class II | |
| K162948 | Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials | Sybron Dental Specialties, Inc. | MVL | Unclassified | |
| K171712 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach | William Cook Europe ApS | DTK | Class II | |
| K171684 | Epix Electrosurgical Probe with Smoke Evacuation | Applied Medical Resources Corp | GEI | Class II | |
| K171386 | dpl SpectraLite | LED Technologies, Inc. | OHS | Class II | |
| K171362 | Merit Syringe | Merit Medical Systems, Inc. | FMF | Class II | |
| K170851 | Anterior Spine Truss System (STS) Interbody Fusion Device | 4WEB Inc. | MAX | Class II | |
| K170738 | InMode Diolaze XL | Inmode MD, Ltd. | GEX | Class II | |
| K170038 | FuzeFix Screw System | Fusion Orthopedics, LLC | HWC | Class II | |
| K172081 | Maestro Microcatheter | Merit Medical Systems, Inc. | KRA | Class II | |
| K171596 | ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle | Wilson-Cook Medical Inc. | FCG | Class II | |
| K171366 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit | Stimwave Technologies Inc., dba Stimq, LLC | GZF | Class II | |
| K171345 | Cellvizio 100 Series Systems with Confocal Miniprobes | Mauna Kea Technologies | OWN | Class II | |
| K171147 | REVEAL Bulk | Bisco Inc | EBF | Class II | |
| K170861 | Premier | Shandong Weigao Orthopaedic Device Co.,Ltd | NKB | Class II | |
| K163393 | Hi-Dow Wireless TENS/EMS System (Model HD-5N) | Hi-Dow International Inc. | NUH | Class II | |
| K163251 | Life Essence Universal Porcelain System | Blue Sky Bio, LLC | EIH | Class II | |
| K160850 | Nucleoss Tpure Implant System | Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti | DZE | Class II | |
| K152300 | Glucommander | Glytec, LLC | NDC | Class II | |
| K172039 | CATHTONG II PICC Catheter | L & z US, Inc. | LJS | Class II | |
| K172036 | Medrobotics Flex Robotic System | Medrobotics Corporation | FDF | Class II | |
| K171456 | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems | Choicespine, LP | NKB | Class II | |
| K171390 | dpl II Panel | LED Technologies, Inc. | OHS | Class II | |
| K171356 | Clarity Reveal | Ceevra, Inc. | LLZ | Class II | |
| K171322 | eCareManager 4.1 | Visicu, Inc. | MSX | Class II | |
| K171164 | U-Lite EXP | Sonoscanner | IYN | Class II | |
| K170928 | CADence System | Aum Cardiovascular, Inc. | DQD | Class II | |
| K170919 | The TiBow Expandable Spacer System | Life Spine | MAX | Class II | |
| K162744 | Everyway OTC EMS, Model EV-805 | Everyway Medical Instrument Co., Ltd. | NGX | Class II | |
| K162507 | Arzzt 3.5 / 4.5 Small & Large Fragments System | Truemed Group, LLC | HRS | Class II | |
| K161358 | Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds | Medline ReNewal | JCX | Class II | |
| K172004 | truSculpt | Cutera Inc | PBX | Class II | |
| K171717 | Autocon III 400 | Karl Storz Endoscopy-America, Inc. | GEI | Class II |