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 |
|---|---|---|---|---|---|
| K170700 | Inqwire Diagnostic Guide Wire | Merit Medical Systems, Inc. | DQX | Class II | |
| K170385 | CORE M2 Vascular System | Volcano Corporation | IYO | Class II | |
| K170171 | IOLMaster 700 | Carl Zeiss Meditec Inc | HJO | Class II | |
| K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film | Medela AG | OMP | Class II | |
| K163469 | ViziShot 2 FLEX | Olympus Surgical Technologies America | KTI | Class II | |
| K163256 | Dual Mode Infrared Thermometer | Intelliworks, LLC | FLL | Class II | |
| K163246 | Leva Anterior Expandable Spacer System | Spine Wave Inc | MAX | Class II | |
| K163233 | MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter | Mivi Neuroscience, Inc. | DQY | Class II | |
| K163220 | Atellica CH Phencyclidine (Pcp) | Siemens Healthcare Diagnostics Inc. | LCM | Unclassified | |
| K163101 | CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set | Microgenics Corporation | DJG | Class II | |
| K162927 | PRECICE UNYTE CoCr System | NuVasive Specialized Orthopedics, Inc. | HSB | Class II | |
| K162925 | AcQGuide Steerable Sheath | Acutus Medical, Inc. | DRA | Class II | |
| K162617 | NobleStitch EL | Nobles Medical Technologies II, Inc. | GAW | Class II | |
| K162488 | Optiflux dialyzer | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K162287 | Synapse 3D Perfusion Analysis | FUJIFILM Healthcare Americas Corporation | LLZ | Class II | |
| K162203 | POGO Automatic Blood Glucose Monitoring System | Intuity Medical, Inc. | NBW | Class II | |
| K161829 | Huvitz Imaging System | Huvitz Co., Ltd. | NFJ | Class II | |
| K161599 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | OMP | Class II | |
| K160323 | FlowKeepers | Dk Electronics, LLC | NGX | Class II | |
| K153763 | Howell Biliary Aspiration Needle | Wilson-Cook Medical Inc. | FCK | Class II | |
| DEN160026 | 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia | 23AndMe, Inc. | PTA | Class II | |
| K170837 | Nio Color 3MP (MDNC-3421) | Barco N.V. | PGY | Class II | |
| K170719 | Anzai Respiratory Gating System | Anzai Medical Co, Ltd. | LHN | Class II | |
| K170677 | Neurovision Nerve Locator Monitor (Nerveana), EMGView Software | Neurovision Medical Product, Inc. | GWF | Class II | |
| K170668 | HeartSpan Steerable Sheath Introducer | Merit Medical Systems, Inc. | DYB | Class II | |
| K170456 | Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology | Stryker Sustainability Solutions | NLQ | Unclassified | |
| K170377 | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM | Richard Wolf Medical Instruments Corp. | GEI | Class II | |
| K163711 | IQon Spectral CT | Philips North America LLC | JAK | Class II | |
| K163509 | XprESS ENT Dilation System | Entellus Medical, Inc. | PNZ | Class II | |
| K163435 | Entellus Medical Reinforced Anesthesia Needle | Entellus Medical, Inc. | BSP | Class II | |
| K163363 | SurgTech Thoracolumbosacral (TLS) Posterior Fixation System | Surgtech, Inc. | NKB | Class II | |
| K163274 | AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument | Aggredyne, Inc. | JOZ | Class II | |
| K163076 | Segment CMR | Medviso AB | LLZ | Class II | |
| K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | Blue Ortho | OLO | Class II | |
| K161982 | C-Reactive Protein Kit for use on SPAPLUS | The Binding Site Group Ltd. | DCN | Class II | |
| K161919 | UltraScan 650 | Cyberlogic, Inc. | MUA | Class II | |
| K161712 | Arm automatic blood pressure monitor | Shenzhen Pump Medical System Co., Ltd. | DXN | Class II | |
| K161341 | Lifesys Pacs | Lifetrack Medical Systems, Inc. | LLZ | Class II | |
| K161332 | NILE Proximal Fixation Spinal System | K2M, Inc | OWI | Class II | |
| K170781 | Mx50n(mx50yqs) | Wide Corporation | PGY | Class II | |
| K170731 | System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight | Vatech Co., Ltd. | MUH | Class II | |
| K170678 | Beta-CrossLaps CalCheck 5 | Roche Diagnostics GmbH | JJX | Class I | |
| K170560 | SAGE Vitrification Kit and SAGE Vitrification Warming Kit | CooperSurgical, Inc. | MQL | Class II | |
| K170411 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | MJN | Class II | |
| K170347 | CD HORIZON™ Fenestrated Screw Set | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K170315 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | IYN | Class II | |
| K170040 | BePOD Cannulated Arthrodesis Screws | Fournitures Hospitalieres Industrie | HWC | Class II | |
| K163613 | Bluephase Style 20i | Ivoclar Vivadent, Inc. | EBZ | Class II | |
| K163459 | Nihon Kohden Vital Sign Telemeter | Nihon Kohden Corp. | MHX | Class II | |
| K163458 | Zenysis Short-Term Dialysis Catheter | C.R. Bard Inc | MPB | Class II |