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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| DEN220082 | Breast Implant Removal Device (BIRD) | Gaylord Solutions, LLC | QVS | Class II | |
| K230766 | Altus Spine Monaco Pedicle Screw System | Altus Spine | NKB | Class II | |
| K230090 | Diode Laser Hair Removal | Wuhan Lotuxs Technology Co.,Ltd. | OHT | Class II | |
| K230053 | SimpliFix Hip System | Stabiliz Orthopaedics | HWC | Class II | |
| K230023 | ART-Plan | Therapanacea SAS | QKB | Class II | |
| K223552 | Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | Brainlab, Inc. | HAW | Class II | |
| K223201 | TAP Lancet | Yourbio Health | FMK | Class II | |
| K223168 | Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface | Medtronic, Inc. | QWF | Class II | |
| K221220 | Montross Extremity Medical Hemi Implant System | Montross Extremity Medical | KWD | Class II | |
| K221042 | Renova RP Centesis Pump | Gi Supply | BTA | Class II | |
| K220288 | NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector | NP Medical | FPA | Class II | |
| K211748 | Selux AST System; Model AST Gen 1.0 | Selux Diagnostics, Inc. | LON | Class II | |
| K230820 | SofWave System | Sofwave Medical Ltd. | OHV | Class II | |
| K230764 | OsteoCentric Integrated Hip Fastener System | OsteoCentric Technologies,Inc | JDO | Class II | |
| K230698 | Anivia SG1000 Pump Console | Apmtd, Inc. | DWA | Class II | |
| K230494 | ClotTriever BOLD Catheter | Inari Medical, Inc. | QEW | Class II | |
| K223784 | Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 | Deltronix Equipamentos Ltda | GEI | Class II | |
| K223513 | UniVy™ OsteoVy™-Ti Cervical IBF System | VY Spine, LLC | ODP | Class II | |
| K221895 | Terumo Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | DTQ | Class II | |
| K213170 | SENSOSEEG Depth Electrodes | Sensomedical Labs Ltd | GZL | Class II | |
| K230772 | Quantib Prostate | Quantib B.V. | LLZ | Class II | |
| K230749 | TriMed Threaded Intramedullary Nail System | Trimed Inc | HWC | Class II | |
| K230544 | SnugFit All-Suture Anchor extension | Medacta International SA | MBI | Class II | |
| K230429 | Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device | Rapid Medical Inc. | NRY | Class II | |
| K223577 | Localite TMS Navigator TS | Localite GmbH | HAW | Class II | |
| K223564 | X-Cube 50, X-Cube 60 | ALPINION MEDICAL SYSTEMS Co., Ltd. | IYN | Class II | |
| K223454 | Custom-made Invisible Aligners | Zhejiang Yinchili Medical Technology Co.,Ltd | NXC | Class II | |
| K222829 | Curian® Shiga Toxin | Meridian Bioscience Inc | GMZ | Class I | |
| K222469 | TIB Abutments | Southern Implants, (Pty.) Ltd. | NHA | Class II | |
| DEN220059 | NTX100 Tonic Motor Activation (NTX100 ToMAc) System | Noctrix Health, Inc. | QWD | Class II | |
| K221974 | EpiFinder | Omeq Medical, Ltd. | FMF | Class II | |
| K213676 | Masimo Rad-G with Temperature | Masimo Corporation | DQA | Class II | |
| K230685 | AutoContour Model RADAC V3 | Radformation, Inc. | QKB | Class II | |
| K230411 | Dragonfly OpStar™ Imaging Catheter | Abbott Medical | DQO | Class II | |
| K223785 | N9+ | Nonagon Ltd. | DQD | Class II | |
| K223705 | EndoflipTM 300 | Medtronic, Inc. | FFX | Class II | |
| K223566 | ELITA™ Femtosecond Laser System, ELITA™ Patient Interface | Advanced Medical Optics, Inc. | OOE | Class II | |
| K223509 | Compremium Compartment Compressibility Monitoring System (CPM#1) | Compremium AG | LXC | Unclassified | |
| K223018 | OSPREY PERIPHERAL IV Catheter System | Skydance Vascular, Inc. | FOZ | Class II | |
| K222066 | LINK MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | LPH | Class II | |
| K221865 | Btl-094 | BTL Industries, Inc | ISA | Class I | |
| K220854 | TrachCuff Cuff Controller | Aw Technologies ApS | BSK | Class II | |
| K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co., Ltd. | MLR | Class II | |
| K230868 | SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control | Maine Molecular Quality Controls, Inc. | PMN | Class II | |
| K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini | BioFire Diagnostics, LLC | QOF | Class II | |
| K230694 | NaviCam Xpress Stomach System, NaviCam Xpress System | Anx Robotica Corp. | QKZ | Class II | |
| K230412 | Symmed Elite Aesthetic | Termosalud | PBX | Class II | |
| K230393 | UniCam Evo Software | Inter Medical Medizintechnik GmbH | LLZ | Class II | |
| K230387 | ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) | Ethicon Endo-Surgery Inc | GEI | Class II | |
| K230264 | Ezra Flash | Ezra AI, Inc. | LLZ | Class II |