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 |
|---|---|---|---|---|---|
| K242458 | ArgenZ MTZ | The Argen Corporation | EIH | Class II | |
| K242086 | MagDI System (MAG-01, DS-01) | GT Metabolic Solutions, Inc. | SAH | Class II | |
| K242034 | Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery | PCB | Class II | |
| K241554 | Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) | Telefield Medical Imaging (Shenzhen) Limited | IYN | Class II | |
| K241089 | KeyPrint KeyDenture Base | Keystone Industries | EBI | Class II | |
| K241007 | Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) | Shenzhen Urion Technology Co., Ltd. | DXN | Class II | |
| K240543 | Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) | Medency SRL | GEX | Class II | |
| K240391 | MUTARS® femoral stem cemented 160 mm and 200 mm | implantcast GmbH | LZO | Class II | |
| K243057 | TrueFit Bolus; TrueFlex Bolus | Adaptiiv Medical Technologies, Inc. | MUJ | Class II | |
| K243012 | MIM – Symphony HDR Fusion | MIM Software Inc | LLZ | Class II | |
| K243007 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K242995 | OIC Small / Mini Fragment Plate System | The Orthopaedic Implant Company | HRS | Class II | |
| K242847 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); | DRTECH Corporation | KPR | Class II | |
| K242829 | BluEX Lumbar Expandable Cage System | L&K Biomed Co.,Ltd. | MAX | Class II | |
| K242589 | Scarlet® AL-T | Spineart SA | MAX | Class II | |
| K242513 | FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) | Guangdong Optomedic Technologies, Inc. | GCJ | Class II | |
| K242183 | Fractional CO2 Laser Therapy System (EXFU CO2) | Weifang Mingliang Electronics Co.,Ltd. | GEX | Class II | |
| K242073 | STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) | TSK Laboratory International Japan KK | QYM | Class II | |
| K241988 | ProSeal™ Closed System Bag Access | Epic Medical Pte., Ltd. | ONB | Class II | |
| K241876 | Vitesse (5.0) | Varian Medical Systems, Inc. | MUJ | Class II | |
| K241753 | Immediate Molar Implants | ZimVie US Corp LLC | DZE | Class II | |
| K241324 | LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system | Affinity Biosensors | SAN | Class II | |
| K240865 | IDS-iSYS Free Testosterone | Immunodiagnostic Systems Ltd. | CDZ | Class I | |
| K240289 | Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) | Scivita Medical Technology Co., Ltd. | EOQ | Class II | |
| K234060 | KIDNEYvault Portable Renal Perfusion System | Paragonix Technologies Inc. | KDN | Class II | |
| K243209 | nordicMEDiVA | NordicNeuroLab AS | LLZ | Class II | |
| K242250 | PuraStat | 3-D Matrix Europe SAS | QAU | Class II | |
| K242193 | Arm Type Blood Pressure Monitor (BPM82) | Avita Corporation | DXN | Class II | |
| K242099 | Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle | Sol-Millennium Medical, Inc. | FMF | Class II | |
| K241758 | Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) | Stryker Sustainability Solutions | NLF | Class II | |
| K241572 | ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) | Shanghai Seegen Photoelectric Technology Co., Ltd | FET | Class II | |
| K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | BrosMed Medical Co.,Ltd. | PNO | Class II | |
| K241398 | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses | Tianjin Mastervision Technology Co., Ltd. | HQD | Class II | |
| K240506 | KARL STORZ Holders | Karl Storz Endoscopy-America, Inc. | OCV | Class II | |
| K242554 | Arthrex VAL and VAL KreuLock™ Compression Screw System | Arthrex GmbH | HRS | Class II | |
| K242266 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | Stryker Corp. | GEI | Class II | |
| K242157 | Anovo Surgical System (Model 6Ne) | Momentis Surgical Ltd. | QNM | Class II | |
| K242058 | Digital Prism Correction Feature (DPCF) | Apple Inc. | SCW | Class I | |
| K241170 | Dynamic TiBase; TRI Screws | Talladium Espana, SL | NHA | Class II | |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Smith & Nephew, Inc. | JDI | Class II | |
| K240029 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | QYX | Class II | |
| K222740 | Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch | Speciality Fibres and Materials Limited | FRO | Unclassified | |
| K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) | Boston Scientific Corporation | GEH | Class II | |
| K243033 | dS Wrist coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | MOS | Class II | |
| K242879 | dS Knee Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | MOS | Class II | |
| K242868 | Kinos Total Ankle System | restor3d, Inc. | HSN | Class II | |
| K242864 | ROSA® Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | OLO | Class II | |
| K242837 | BriefCase-Triage | Aidoc Medical Ltd. | QAS | Class II | |
| K242828 | Corplex P/ Theracor P/ Allacor P | Stimlabs, LLC | KGN | Unclassified |