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 |
|---|---|---|---|---|---|
| K200752 | DB-Orthopedics | Dimensional Bioceramics, LLC | MQV | Class II | |
| K200585 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K200185 | Sylfirm X | VIOL Co., Ltd. | GEI | Class II | |
| K200168 | Dermapose Access | Puregraft, LLC | QPB | Class II | |
| K192517 | Psychemedics Microplate EIA for Cotinine in Hair | Psychemedics Corp. | MKU | Class I | |
| K191997 | FAICO CMF System | Faico Medical, LLC | JEY | Class II | |
| K191882 | Masimo Centroid System | Masimo Corporation | MWI | Class II | |
| K190984 | Infrared Forehead Thermometer | Xiamen Ants Bro Technology Co., Ltd. | FLL | Class II | |
| K200745 | Lariat, Hot/Cold Snare | United States Endoscopy Group, Inc. | FDI | Class II | |
| K200744 | Instylla Microcatheter | Instylla, Inc. | KRA | Class II | |
| K200162 | Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) | Wuhan Greentek Pty Ltd. | GXY | Class II | |
| K200053 | DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) | Dannik | GCJ | Class II | |
| K193351 | NinesAI | Nines, Inc. | QAS | Class II | |
| K193161 | Pristine Scope | Pristine Surgical LLC | GCJ | Class II | |
| K193074 | Bevel Up Holder | NSP Tech Pte Ltd | JKA | Class II | |
| K192701 | DIBS (Digital Indirect Bonding System) | Orthoselect | PNN | Class II | |
| K192609 | Globalcare Blood Pressure Monitor | Globalcare Medical Technology Co., Ltd | DXN | Class II | |
| K192492 | EL CAPITAN Anterior Lumber Interbody System | Astura Medical | OVD | Class II | |
| K192145 | Galileo Vertebral Body Replacement Device | Bright Spine | PLR | Class II | |
| K192082 | Droplet Pen Needle 34G | HTL-Strefa S.A. | FMI | Class II | |
| K192034 | HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc | Pathway, LLC | EZL | Class II | |
| K200600 | Sentinel | C-Rad Positioning AB | IYE | Class II | |
| K200559 | CarpX | Pavmed, Inc. | GEI | Class II | |
| K200122 | MOTO PFJ System | Medacta International SA | KRR | Class II | |
| K200024 | uMR 570 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K193343 | Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) | VitalConnect, Inc. | DRG | Class II | |
| K193197 | QuickClear Mechanical Thrombectomy System | Volcano Atheromed, Inc. | QEZ | Class II | |
| K193032 | KY Grosz Liquid | Rb Health (Us), LLC | NUC | Class II | |
| K192382 | CapKlenZ | Star Mountain Medical, Inc. | QBP | Class II | |
| K192154 | Rio Vial-to-Bag Drug Reconstitution Device | Abbott Medical | LHI | Class II | |
| K200121 | Route 92 Medical 088 Access System, 110 cm | Route 92 Medical, Head Quarters | QJP | Class II | |
| K191995 | S4 Screw System | Subchondral Solutions | HWC | Class II | |
| K200868 | SI-Restore Sacroiliac Joint Fixation System | Biofusion Medical | OUR | Class II | |
| K200733 | Opticross 35 15 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | ITX | Class II | |
| K200712 | Rumble Tuff Electric Breast Pump | A Cute Baby, Inc. | HGX | Class II | |
| K200709 | Kyocera Bipolar Hip System | Kyocera Medical Technologies, Inc. | KWY | Class II | |
| K200338 | ProLift Lateral Fixated | Life Spine | OVD | Class II | |
| K200257 | WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System | Boston Scientific Corporation | MQR | Class II | |
| K200158 | Logiq E10 | GE Healthcare | IYN | Class II | |
| K200118 | Diode Laser Therapy Device | Shanghai Apolo Medical Technology Co.,Ltd. | GEX | Class II | |
| K192552 | Irradiation Cosmetic Device | Chongqing Peninsula Medical Technology Co., Ltd. | OAP | Class II | |
| K191720 | BRUIS Software Suite | Mechanodontics, Inc. | PNN | Class II | |
| K200755 | Caption Guidance | Caption Health | QJU | Class II | |
| K200729 | HydroCision SpineJet System | Hydrocision, Inc. | HRX | Class II | |
| K200670 | EON Portable RO Water Purification System | Evoqua Water Technologies LLC | FIP | Class II | |
| K200547 | Traxcess 14 SELECT Guidewire | Terumo Cardiovascular Systems Corporation | MOF | Class II | |
| K193588 | DD Contrast | Dental Direkt GmbH | EIH | Class II | |
| K193549 | SIGMA High Performance (HP) Partial Knee System | Depuy Ireland UC | HRY | Class II | |
| K193326 | ARTIS Icono | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K193124 | Unicel DxH 800 Coulter Cellular Analysis System | Siemens Healthcare Diagnostics Inc. | GKZ | Class II |