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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K133087 | Abbvie Peg | AbbVie Inc | KNT | Class II | |
| K132891 | Hydrolyzed Collagen/ag Wound Gel with Silver | The Hymed Group Corp. | FRO | Unclassified | |
| K132869 | Sildent | Hrs Co., Ltd. | ELW | Class II | |
| K130694 | Jr Implant System | LK Consulting Group USA, Inc. | DZE | Class II | |
| K141363 | Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis Catheter | Merit Medical Systems, Inc. | MSD | Class II | |
| K141313 | Reverse Medical Micro Vascular Plug System | Reverse Medical Corporation | KRD | Class II | |
| K141029 | Tornier Aequalis Adjustable Reverse Shoulder System | TORNIER Inc. | PHX | Class II | |
| K140583 | Digital Automatic Blood Pressure Monitor Bpm20 Series | Grandway Technology (Shenzhen) Limited | DXN | Class II | |
| K140067 | Qardioarm | Qardio, Inc. | DXN | Class II | |
| K133295 | Qualis | Menicon Co., Ltd. New Business Division | MQK | Class II | |
| K133096 | Abb Vie J | AbbVie Inc | KNT | Class II | |
| K130733 | Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored) | Benteng Plastic Co., Ltd. | LYZ | Class I | |
| K130581 | Konix Sterile Gel | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | MUI | Class II | |
| K140450 | Keeler Kapture Software | Keeler Ltd. | HKI | Class II | |
| K140441 | Bi-Flex Ureteral Access Sheath | Promepla S.A.M | KNY | Class II | |
| K140159 | S9 Wanda Vpap St | ResMed Corp | BZD | Class II | |
| K133635 | Easypoint Needle | Retractable Technologies, Inc. | FMI | Class II | |
| K132833 | Ultra Renew Plus | Accord Media | OLP | Class II | |
| K140992 | Arthrocare Nasastent Cmc Nasal Dressing | ArthroCare Corporation | LYA | Class I | |
| K140760 | Bonastent Biliary | Boston Scientific Corporation | FGE | Class II | |
| K140713 | Planmeca Romexis | Planmeca Oy | LLZ | Class II | |
| K140708 | Verify V24 Self-Contained Biological Indicator | STERIS Corporation | FRC | Class II | |
| K140623 | Nxstage Express Fluid Warmer | NxStage Medical Inc | FLA | Class II | |
| K140570 | Chairside Attachment Processing Material | Zest Anchors LLC | EBI | Class II | |
| K140562 | Wijay Ez-Void External Catheter Valve | Leomed, LLC | KNY | Class II | |
| K140519 | Recovery Pump 737R | MEGO AFEK AC Ltd. | IRP | Class II | |
| K140443 | Arietta 60/Ariettas60/ariettav60 | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | IYN | Class II | |
| K140317 | Embryogen | CooperSurgical, Inc. | MQL | Class II | |
| K140215 | One Step Single/multi-Drug Test Cup/dipcard | Co-Innovation Biotech Co.,Ltd. | DIS | Class II | |
| K140134 | Esophageal Stethoscope with Temperature Sensor (Non-Sterile),esophageal Stethoscope Temperature with Attached Ear Piece | Starboard Medical, Inc. | BZT | Class II | |
| K140073 | U2 Femoral Component, Cr, Cemented | United Orthopedic Corp. | JWH | Class II | |
| K140006 | Endoshield Burn Protection System | Encision, Inc. | GEI | Class II | |
| K133965 | OTC Ems Stimulator | Shenzhen Dongdixin Technology Co., Ltd. | NGX | Class II | |
| K133439 | Pilling Esophageal Bougies | Teleflexmedical, Inc. | FAT | Class II | |
| K132289 | Gemss Medical Systems Surgical Mobile Fluoroscopic X-Ray System | Gemss Medical Systems Co., Ltd. | JAA | Class II | |
| K132566 | Reprocessed Harmonic Shear | Sterilmed Inc | NLQ | Unclassified | |
| K141520 | Alere I Influenza a & B | Alere Scarborough, Inc D/B/A Binax, Inc. | OCC | Class II | |
| K141383 | Acumed Hand Fracture System | Acumed LLC | HRS | Class II | |
| K141055 | Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5Ml), (15Ml); Controls; (5Ml), (15Ml) | Lin-Zhi International Inc | DJG | Class II | |
| K140960 | Picture Archiving and Communications System | Hologic, Inc. | LLZ | Class II | |
| K140799 | Celerity Sysyem | Medcomp ( Medical Components) | LJS | Class II | |
| K140759 | Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar, Cougar System, Cougar Ls Lateral | Medos International SARL | MAX | Class II | |
| K140666 | Mr Elastography | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K140462 | Matrixneuro Preformed Mesh (Part of the Matrixneuro Cranial Plating System) | Synthes (USA) Products LLC | GWO | Class II | |
| K140437 | Su-Por Surgical Implant | Poriferous, LLC | KKY | Class II | |
| K140430 | 740 Select | Cas Medical Systems, Inc. | MWI | Class II | |
| K140312 | Ev1000 Clinical Platform with Clearsight Tm Finger Cuff or Clearsight Tm System | Edwards Lifesciences LLC | DXN | Class II | |
| K140075 | U2 Femoral Component, Cr, Porous Coated | United Orthopedic Corp. | MBH | Class II | |
| K133884 | Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5mm | Biodenta Swiss AG | DZE | Class II | |
| K133661 | Chair Sensing Unit for Earlysense System | Earlysense, Ltd. | BZQ | Class II |