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 |
|---|---|---|---|---|---|
| K190452 | Aptima BV Assay | Hologic, Inc. | PQA | Class II | |
| K190441 | Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit | Cepheid | QEP | Class II | |
| K190436 | KATANA Zirconia Block | Kuraray Noritake Dental, Inc. | EIH | Class II | |
| K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs | Ansell Healthcare Products LLC | KGO | Class I | |
| K183654 | PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus | PENTAX of America, Inc. | EOQ | Class II | |
| K183639 | Mariner Outrigger Revision System | SeaSpine Orthopedics Corporation | NKB | Class II | |
| K183560 | Luna 3D GEN2 Interbody Fusion System | Benvenue Medical, Inc. | MAX | Class II | |
| K183054 | SYNMESH System | Depuy Synthes Spine | MQP | Class II | |
| K182937 | Upstream GoBack Crossing Catheter | Upstream Peripheral Technologies Ltd. | DQY | Class II | |
| K182458 | Longterm NPWT Foam Dressing Kit | Zhejiang Longterm Medical Technology Co., Ltd | OMP | Class II | |
| K182390 | IMPEDE-FX Embolization Plug | Shape Memory Medical Inc | KRD | Class II | |
| K182362 | MaxCap Ped and MaxCap Neo | Maxtec, LLC | CCK | Class II | |
| DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA | Inbios International, Inc. | QFO | Class II | |
| DEN180032 | Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit | CD Diagnostics, Inc | QGN | Class II | |
| K191080 | Ambu aScope 4 RhinoLaryngo Slim | Ambu A/S | EOB | Class II | |
| K190902 | RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope | Wenzhou Renhua Instruments Co.,Ltd | DXQ | Class II | |
| K190823 | Erbe ESU Model VIO 3 with Accessories | ERBE Elektromedizin GmbH | GEI | Class II | |
| K190769 | Bladder Scanner (Models: M2, M2-W, M1, M1-W) | Suzhou Lischka Medtech Co., Ltd. | IYO | Class II | |
| K190751 | Connector System | Orthofix SRL | NKG | Class II | |
| K190444 | HERA I10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K190433 | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit | Roche Molecular Systems Inc | QEP | Class II | |
| K183644 | Stealth-Midas MR8 System | Medtronic Powered Surgical Solutions | OLO | Class II | |
| K183611 | Soniquence RF Generator and Soniquence Electrodes | Soniquence, LLC | GEI | Class II | |
| K182374 | Liac S | Sit Sordina Iort Technologies SpA | IYE | Class II | |
| K182350 | Dental Ceramic | Baot Biological Technology Co., Ltd. | EIH | Class II | |
| K190367 | Smith & Nephew Tablet Application | Smith & Nephew, Inc. | QGY | Class II | |
| K183646 | Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure | Edwards Lifeciences, LLC | QAQ | Class II | |
| K183242 | ET IV SA Dental Implants | Hiossen, Inc. | DZE | Class II | |
| K182975 | Mako 7 | Boston Scientific Corporation | HIH | Class II | |
| K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | GWO | Class II | |
| K182576 | Solax Powered Wheelchair | Dongguan Prestige Sporting Goods Co., Ltd. | ITI | Class II | |
| K182342 | IntraLock Lapidus System | Fusion Orthopedics, LLC | HWC | Class II | |
| K190332 | Aperio AT2 DX System | Leica Biosystems Imaging, Inc. | PSY | Class II | |
| K190134 | Full Automatic (NIBP) Blood Pressure Monitor-HL158TB | Health & Life Corporation | DXN | Class II | |
| K183655 | VersaCross Transseptal Sheath | Baylis Medical Co., Inc. | DYB | Class II | |
| K182235 | OnSite Waste Sharps Container | Bluestone Medical, Inc. | MMK | Class II | |
| DEN180059 | Nerivio Migra | Theranica Bio-Electronics Ltd. | QGT | Class II | |
| K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | T.A.G. Medical Products Corporation Ltd | MBI | Class II | |
| K183597 | QIAstat-Dx Respiratory Panel | Qiagen | OCC | Class II | |
| K191029 | Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac | Medtronic, Inc. | DTZ | Class II | |
| K191025 | DRX-Revolution Mobile X-ray System | Eastman Kodak Company | IZL | Class II | |
| K191015 | Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) | Cook Incorporated | MQF | Class II | |
| K190675 | Dimension EXL High-Sensitivity Troponin I (TNIH) Assay | Siemens Healthcare Diagnostics Inc. | MMI | Class II | |
| K183618 | Revolution Radial Head | Ignite Orthopedics, LLC | KWI | Class II | |
| K183505 | KY Banksy Moisture | Rb Health (Us), LLC | NUC | Class II | |
| K183417 | iRestore Professional 282 | Freedom Laser Therapy Inc | OAP | Class II | |
| K183381 | Navigation Enabled Instruments | Stryker Corp. | OLO | Class II | |
| K183077 | Delta Xtend Reverse Shoulder System | Depuy (Ireland) | PHX | Class II | |
| K183035 | Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle | Cook Incorporated | LJE | Unclassified | |
| K182394 | WiZARD 310/320 Series CPAP Mask | Apex Medical, Inc. | BZD | Class II |