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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K150901 | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express | Edan Instruments, Inc. | HGM | Class II | |
| K150889 | Suture Wires and Wire Loops | Zimmer GmbH | JDQ | Class II | |
| K150873 | CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System | Accuray Incorporated | IYE | Class II | |
| K150724 | SculpSure | Cynosure, LLC | PKT | Class II | |
| K143688 | Asfora Anterior Cervical Plate System | Medical Designs, LLC | KWQ | Class II | |
| K143271 | CastleLoc-P Anterior Cervical Plate System | L&K Biomed Co.,Ltd. | KWQ | Class II | |
| K143227 | Magellan Robotic System, Magellan Robotic Catheter 10Fr | Hansen Medical, Inc. | DXX | Class II | |
| K142845 | SILKPRO laser hair removal system | Wuhan Lotuxs Technology Co.,Ltd. | OHT | Class II | |
| K151485 | Genesis | Dornier Medtech America, Inc. | JAA | Class II | |
| K151331 | The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch | Lumenis Ltd | GEX | Class II | |
| K151290 | Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff | Xuzhou Maicuff Technology Co., Ltd. | DXQ | Class II | |
| K151281 | AGE Automatic Wrist Blood Pressure Monitor | Dongguan Ageless Health Industrial Co., Ltd. | DXN | Class II | |
| K151246 | Aneroid Sphygmomanometer | Jiaxing Zhongfa Medical Products Co., Ltd. | DXQ | Class II | |
| K151224 | Lineum OCT Spine System | Highridge Medical, LLC | NKG | Class II | |
| K150591 | Besmed Reusable Jet Nebulizer | Besmed Health Business Corporation | CAF | Class II | |
| K150574 | Modular Power Positioning System | Motion Concepts LP | ITI | Class II | |
| K150493 | Sensis | Siemens Medi Cal Solutions, Inc. | DQK | Class II | |
| K150445 | ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K150320 | Compass | Centervue | MYC | Class II | |
| K150167 | V60 Anesthetic Vaporizer | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | CAD | Class II | |
| K143474 | Artemis Hand Held Imaging System | Quest Medical Imaging | OWN | Class II | |
| K142642 | Vitalograph Model 6600 Compact | Vitalograph Ireland Ltd. | BZG | Class II | |
| K141680 | AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws | Auxein Medical | HRS | Class II | |
| K151465 | AeroDR SYSTEM 2 | Konica Minolta, Inc. | MQB | Class II | |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | WHPM Inc. | DJR | Class II | |
| K151201 | Stryker ICONIX with Needles | Stryker Corp. | MBI | Class II | |
| K150925 | Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set | Immunalysis Corporation | DIO | Class II | |
| K150518 | Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm | Dupaco, Inc. | JXL | Class II | |
| K150363 | NOVA Dental Implants System | Nova Implants Ltd | DZE | Class II | |
| K150327 | Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 | Dunamis, LLC | GAT | Class II | |
| K143484 | BioZorb Marker | Focal Therapeutics | NEU | Class II | |
| K143411 | Traus Endo | Saeshin Precision Co., Ltd. | EKX | Class I | |
| K142812 | Vitalograph Model 6800 Pneumotrac | Vitalograph Ireland Ltd. | BZG | Class II | |
| K141933 | Filao Nc Rx Ptca Dilatation Catheter | Natec Medical Ltd | LOX | Class II | |
| K150494 | Proteus Digital Health Feedback Device | Proteus Digital Health, Inc. | OZW | Class II | |
| K151116 | CapLOX II/TowerLOX Pedicle Screw System | CAPTIVA SPINE, Inc. | MNH | Class II | |
| K150680 | Freedom Cementless Femoral Component | Maxx Orthopedics Inc. | MBH | Class II | |
| K150041 | CORA (Coagulation Resonance Analysis) System | Coramed Technologies, LLC | JPA | Class II | |
| K143581 | Arrow Epidural Catheter Kit | Teleflexmedical, Inc. | CAZ | Class II | |
| K143449 | ADH 200 Analyzer Software | Adams Meditech, LLC | DQK | Class II | |
| K143398 | Plato MICROCATH 27B Microcatheter | Scientia Vascular | DQO | Class II | |
| K143071 | Nacera Pearl | Doceram Medical Ceramics GmbH | EIH | Class II | |
| K142750 | JiveX | Visus Technology Transfer GmbH | LLZ | Class II | |
| K140820 | Xenomem Wound Matrix | Viscus Biologics, LLC. | KGN | Unclassified | |
| K151509 | GSI TympStar Pro Middle Ear Analyzer | Diagnostic Group, dba Grason-Stadler | ETY | Class II | |
| K151398 | K-Pack II Needle - 29G x 5/16 Thin Wall | Terumo Europe N.V. | FMI | Class II | |
| K151214 | ALIF Interfixated System | Nu Vasive, Incorporated | OVD | Class II | |
| K150975 | Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | |
| K150951 | aeris Balloon Dialation Catheter | Bryan Medical Inc | KTI | Class II | |
| K150538 | Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider | Stryker Sustainability Solutions | NUJ | Class II |