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 |
|---|---|---|---|---|---|
| K253598 | InjecSURE Injection System | Carbon Medical Technologies, Inc. | FBK | Class II | |
| K253029 | Rw-1 | Mediott, Inc. | LLZ | Class II | |
| K260812 | Francisella tularensis Real-time PCR Assay | Centers for Disease Control and Prevention | SGA | Class II | |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (Hunan) Co.,Ltd. | EIH | Class II | |
| K260037 | implantcast Packaging System Update | implantcast GmbH | LZO | Class II | |
| K254207 | AiORTA - Plan v2.0 | Vitaa Medical Solutions Inc | QIH | Class II | |
| K254122 | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | GEI | Class II | |
| K253950 | Avatar Medical Vision | Avatar Medical | LLZ | Class II | |
| K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Boblingen GmbH | MSX | Class II | |
| K252269 | FINDER Flu A&B/SARS-CoV-2 Test | Baebies Inc. | QOF | Class II | |
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine Inc | ODP | Class II | |
| K252158 | Sagami Original 002 Polyurethane Male Condom | Mayer Laboratories | MOL | Class II | |
| K260257 | CO2 Laser System | Sanhe Meditech Co., Ltd | GEX | Class II | |
| K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana Inc. | SAT | Class II | |
| K260746 | S-scan Open (100001800) | Esaote S.p.A. | LNH | Class II | |
| K260697 | VyPlate™ Anterior Cervical Plate System | VY Spine, LLC | KWQ | Class II | |
| K260294 | SF Push-in Anchor | SURGICAL FUSION TECHNOLOGIES GmbH | MAI | Class II | |
| K260271 | Strauss Surgical cystoscope, hysteroscope and accessories Instruments | American Medical Endoscopy | FAJ | Class II | |
| K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical Inc | GEI | Class II | |
| K260240 | SYMPHONY Navigation Ready Instruments | Medos International SARL | OLO | Class II | |
| K260041 | MDx-Chex for BCP | Streck LLC | PMN | Class II | |
| K254239 | CyClean Cord | SS Global | MVL | Unclassified | |
| K254206 | Power wheelchair (ZS-EW8026) | Ningbo Zhishan Medical Technology Co., Ltd. | ITI | Class II | |
| K254161 | Automated Aortic Stenosis Software (AutoAS) | GE Healthcare | POK | Class II | |
| K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K253980 | Electrically Powered Wheelchair (Model YC-01) | Yurob Rehabilitation Medical Co.,Ltd | ITI | Class II | |
| K253822 | GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | Zhuhai Fitlens Medical Technology Co., Ltd | HQD | Class II | |
| K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies Ltd. | JAK | Class II | |
| K253625 | Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | |
| K253595 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K253572 | STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device | Ethicon, Inc | GAW | Class II | |
| K253392 | Synergy Disc Instruments | Synergy Spine Solutions Inc | QLQ | Class II | |
| K253307 | Electric wheelchair | Foshan Dahao Medical Technology Co.,Ltd. | ITI | Class II | |
| K253270 | Contour ProtégéAI+ | MIM Software Inc | QKB | Class II | |
| K252893 | ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) | Aneuvo | SDO | Class II | |
| K252295 | Ryurei | Terumo Corp. | LOX | Class II | |
| K252195 | ARTICOR planner | Artiness S.R.L | LLZ | Class II | |
| K252148 | Butterfly Gestational Age Tool | Butterfly Network, Inc. | IYN | Class II | |
| K252081 | SportLinc Syndesmosis Device | Lincotek Medical LLC | HTN | Class II | |
| K252064 | MedCAD® AccuStride™ System | MedCAD | PBF | Class II | |
| K252006 | OTTO™ Disinfecting Cap | Abbott Medical | QBP | Class II | |
| K251273 | Asurys Fluid Management System | Boston Scientific Corporation | HIG | Class II | |
| K260626 | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | DYB | Class II | |
| K260601 | Real Intelligence™ Cori™ | Blue Belt Technologies, Inc. | OLO | Class II | |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | bioMerieux, Inc. | LON | Class II | |
| K260273 | Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) | Shenzhen Urion Technology Co., Ltd. | DXN | Class II | |
| K253796 | Lunit INSIGHT DBT (V1.2) | Lunit Inc. | QDQ | Class II | |
| K253775 | SwiftMR | AIRS Medical Inc. | QIH | Class II | |
| K253627 | Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) | Surgify Medical Oy | HBE | Class II | |
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | Sunrise Medical, Inc. | CAW | Class II |