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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K233768 | Papacarie Duo | Elevate Oral Care, LLC | LBH | Class II | |
| K233482 | Equinoxe® Central Screw Baseplate System | Exactech, Inc. | PHX | Class II | |
| K221495 | SOLID CLIP™ Single Use Clip Applier | Medscope Biotech Co., Ltd. | FZP | Class II | |
| K212521 | Field Shield Wound Dressing | Kericure, Inc. | FRO | Unclassified | |
| K241467 | Stable-C Interbody System | Nexus Spine, L.L.C. | OVE | Class II | |
| K241413 | sagAlign Lumbar Cage System (Various PNs) | Acuity Surgical Devices, LLC | MAX | Class II | |
| K241121 | Micsi-Rmt | Microstructure Imaging, Inc | LLZ | Class II | |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | Topcon Corp. | OBO | Class II | |
| K240845 | Rayvolve | Azmed SAS | QBS | Class II | |
| K240705 | Vitrea Software Package, VSTP-002A V2.0 | Canon Medical Systems Corporation | LLZ | Class II | |
| K240609 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | DZE | Class II | |
| K240503 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | KNF | Class II | |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | Acist Medical Systems, Inc. | DXO | Class II | |
| K241741 | SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel | Guangzhou Wondfo Biotech Co., Ltd. | NGL | Class II | |
| K241740 | Finesse Injectable™ PTA Balloon Dilatation Catheter | Summa Therapeutics, LLC | LIT | Class II | |
| K241441 | RadiForce RX670; RadiForce RX670-AR | Eizo Corporation | PGY | Class II | |
| K241056 | Light Cure Adhesive | Sincera Technology (Changchun) Co., Ltd | KLE | Class II | |
| K241050 | CrossRoads Modular Tray System | Crossroads Extremity Systems LLC | KCT | Class II | |
| K240944 | Swoop® Portable MR Imaging® System | Hyperfine, Inc | LNH | Class II | |
| K240272 | Electric Scooter (M2085, S2091) | Guangdong Prestige Technology Co., Ltd. | INI | Class II | |
| K233778 | Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) | Zhuhai Pusen Medical Technology Co., Ltd. | FGB | Class II | |
| DEN230061 | allay Nerve Cap | Tulavi Therapeutics | SBG | Class II | |
| K241751 | NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat | Positrigo AG | KPS | Class II | |
| K241739 | Endoscopic Applicator, 41 cm | Micromedics, Inc. | GCJ | Class II | |
| K241032 | BellaTek Bars | ZimVie US Corp LLC | NHA | Class II | |
| K240616 | Faq™ (102) | Foreo Inc | PAY | Class II | |
| K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00) | Huxley Medical | MNR | Class II | |
| K240178 | Rfg-01 | Zimmer Medizinsysteme GmbH | PBX | Class II | |
| K233460 | CM00622 LINC Skin Closure System (CM00622 LINC) | Connexicon Medical, Ltd. | OMD | Class II | |
| K233458 | CM005 Standard (CM005); CM004 Mini (CM004) | Connexicon Medical, Ltd. | MPN | Class II | |
| K233449 | Avantik VTM | Hanchang Medic Co., Ltd. (Han Chang Medic) | JSM | Class I | |
| DEN230092 | Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) | DiaSorin Molecular LLC | SBT | Class II | |
| K241385 | Omnifix Syringe NRFit | B.Braun Medical, Inc. | QEH | Class II | |
| K241727 | BriefCase-Triage | Aidoc Medical Ltd. | QAS | Class II | |
| K241720 | VersaCross Connect™ Transseptal Dilator | Baylis Medical Co., Inc. | DRE | Class II | |
| K241715 | Dental Glass Ceramics Blocks (HT,LT,ST) | Aidite (Qinhuangdao) Technology Co., Ltd | EIH | Class II | |
| K241713 | HiRise (1040-230) | CurveBeam, LLC | JAK | Class II | |
| K241707 | OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ | Unicon Optical Co., Ltd. | LPL | Class II | |
| K241705 | MilkMate Breast Pump (A0006); MilkMate Kit (sterile, single-use only), 21 mm breast shield (A0005-21); MilkMate Kit (sterile, single-use only), 24 mm breast shield (A0005-24) | Milkmate Products, Inc. | HGX | Class II | |
| K241500 | Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) | Guangzhou Red Pine Medical Instrument Co.,Ltd. | FAJ | Class II | |
| K241378 | S.I.N. Instrument Kits | S.I.N. Implant System Ltda | KCT | Class II | |
| K241085 | Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) | Medtronic, Inc. | GEI | Class II | |
| K241031 | TMINI Miniature Robotic System (TMINI 1.1) | Think Surgical Inc. | OLO | Class II | |
| K241018 | KLS Martin Orthopedic Implants - MR Conditional | KLS-Martin L.P. | HRS | Class II | |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS) | Deka Research & Development Corp. | KPO | Class II | |
| K240661 | Geistlich Bio-Oss® | Geistlich Pharma AG | NPM | Class II | |
| K240651 | MRI Universal | Stryker Leibinger GmbH & Co. KG | JEY | Class II | |
| K240247 | “MoFi” Cell Culture Basal Medium | Duogenic Stemcells Corporation | NDS | Class II | |
| K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems | Prismatik Dentalcraft, Inc. | NHA | Class II | |
| K234124 | Single Use Hemoclips | Promisemed Hangzhou Meditech Co.,Ltd. | PKL | Class II |