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 |
|---|---|---|---|---|---|
| K192404 | Patient Monitoring Cable (SpO2 Extension Cable) | Shenzhen Coreray Technology Co., Ltd. | DSA | Class II | |
| K192337 | Zeroveno | Dimedi Co., Ltd. | JOW | Class II | |
| K201430 | InFrame™ Cannulated Fixation System | Exsomed Corp. | HWC | Class II | |
| K191923 | EverLift Submucosal Lifting Agent | Gi Supply | PLL | Class II | |
| K201370 | Multiflex Tinnitus Technology | Starkey Laboratories, Inc. | KLW | Class II | |
| K201340 | Aquila 320 D / Aquila 320 S | Vmi Tecnologias Ltda | IZL | Class II | |
| K201339 | The NOxBOXi Nitric Oxide Delivery System | Praxair, Inc. | MRN | Class II | |
| K200671 | Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for | Ansell Healthcare Products LLC | LZA | Class I | |
| K200574 | EksoNR | Ekso Bionics | PHL | Class II | |
| K200471 | Infrared Thermometer Model Number RN-60A,RN-60B | Ningbo Ranor Medical Science & Technology Co., Ltd. | FLL | Class II | |
| K200438 | MPS 3 Myocardial Protection System | Quest Medical, Inc | DTR | Class II | |
| K193298 | BriefCase | Aidoc Medical Ltd. | QAS | Class II | |
| K193106 | SpineFrontier Lumbar Interbody Fusion Device System | SPINEFRONTIER, Inc. dba LESspine Innovations | MAX | Class II | |
| K192963 | Kogent Torus Ultrasonic Aspirator | Katalyst Surgical, LLC | LFL | Unclassified | |
| K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl | Comfort Rubber Gloves Industries Sdn Bhd | LZA | Class I | |
| K192910 | STATClave G4 Chamber Autoclave | Scican Ltd. | FLE | Class II | |
| K192024 | Cemented TSI Hip Stem | Signature Orthopaedics Pty Limited | LZO | Class II | |
| K191913 | TruAbutment DS | TruAbutment Inc. | NHA | Class II | |
| K190637 | Fit & Brilliant Dental Implant System | F&B Technology Co., Ltd. | DZE | Class II | |
| K201347 | DePuy ATTUNE™ Total Knee System | Depuy Orthopaedics Inc. | OIY | Class II | |
| K201337 | InPen System | Companion Medical, Inc. | NDC | Class II | |
| K201327 | NavLock Trackers | Medtronic Navigation, Inc | OLO | Class II | |
| K201311 | PF4 IgG assay | Immucor GTI Diagnostics, Inc. | LCO | Class II | |
| K200892 | Harvey(R) Surgical Assistant | OrthAlign, Inc. | OLO | Class II | |
| K200727 | TENS and Muscle Stimulator | Shenzhen Astec Technology Co., Ltd. | NUH | Class II | |
| K200481 | Andorate Biopsy Valve, Andorate Biopsy Irrigator | GA Health Company Limited | ODC | Class II | |
| K200424 | Giotto Class (Models - 3000X-YY and 4000X-YY) | IMS GIOTTO S.p.A. | MUE | Class II | |
| K200297 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | DXN | Class II | |
| K200283 | Medussa-PL Cage | Medyssey USA | MAX | Class II | |
| K193620 | OptoMonitor 3 | Opsens Inc. | DXO | Class II | |
| K193513 | SIGNAFUSE Bioactive Bone Graft | Bioventus LLC | MQV | Class II | |
| K193234 | NUVO IF Implant System | JJGC Industria e Comercio de Materiais Dentarios SA | DZE | Class II | |
| K192604 | Servo-air 4.0 Ventilator System | Maquet Critica Care AB | CBK | Class II | |
| K192274 | BV Dental Implant System | Bio Concept Co., Ltd. | DZE | Class II | |
| K201322 | Entuit Nasal Jejunal Feeding Tube | Wilson-Cook Medical Inc. | KNT | Class II | |
| K201319 | Medline UNITE Jones Fracture Screw System | Medline Industires, Inc. | HWC | Class II | |
| K201220 | Aerus Medical Guardian,model F170A | Aerus Medical, LLC | FRA | Class II | |
| K201029 | Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System | Spinal Elements, Inc | KWQ | Class II | |
| K200921 | qER | Qure.ai Technologies Inc | QAS | Class II | |
| K200875 | ArtiSential Laparoscopic Instruments - Electrodes | LivsMed Inc. | GEI | Class II | |
| K200389 | INOmax DSIR Plus | Mallinckrodt Manufacturing LLC | MRN | Class II | |
| K193399 | Miru 1day UpSide (midafilcon A) | Menicon Co. Ltd. | LPL | Class II | |
| K193290 | AI-Rad Companion Brain MR | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K193253 | Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 | Shenzhen Changkun Technology Co., Ltd. | FLL | Class II | |
| K192747 | Yxoss CBR® | Reoss GmbH | JEY | Class II | |
| K192478 | LT Antibacterial Alginate with Silver Dressing | Zhejiang Longterm Medical Technology Co., Ltd | FRO | Unclassified | |
| K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | ConforMIS, Inc. | JWH | Class II | |
| K200467 | Control-IQ Technology | Tandem Diabetes Care, Inc. | QJI | Class II | |
| K193540 | TRUMATCH Personalized Solutions | Depuy Orthopaedics Inc. | JWH | Class II | |
| K193288 | Koya Ripple | Koya, Inc. | JOW | Class II |