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 |
|---|---|---|---|---|---|
| K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter | Abbott Medical | DRF | Class II | |
| K151616 | At235 | Interacoustics a/S | ETY | Class II | |
| K151418 | Monster Screw System | Paragon 28 | HWC | Class II | |
| K151021 | OsteoMed Cannulated Screw System | Osteomed | HWC | Class II | |
| K150903 | EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural | Maanshan Bond Medical Instruments Co., Ltd. | MQX | Class II | |
| K150878 | Ilumien Optis | Lightlab Imaging, Inc. | NQQ | Class II | |
| K150700 | ACP 1 Anterior Cervical Plating System | Stryker Corp. | KWQ | Class II | |
| K150611 | MedSource ClearSafe Safety IV Catheter | Medsource International, LLC | FOZ | Class II | |
| K150555 | BA400 14mm Abutment | Cochlear Americas | MAH | Class II | |
| K143115 | The VersaJet II Hydrosurgery System | Smith & Nephew, Inc. | FQH | Class II | |
| K151330 | Microlife Wrist Watch Blood Pressure Monitor | Microlife Intellectual Property GmbH, Switzerland | DXN | Class II | |
| K151196 | Nautilus Spinal System | Life Spine | NKB | Class II | |
| K151184 | InFill Interbody Fusion Devices | Pinnacle Spine Group, LLC | MAX | Class II | |
| K150983 | Pyrenees Cervical Plate System | K2M, Inc | KWQ | Class II | |
| K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Reusable Inner Cannula | Medtronic, Inc. | JOH | Class II | |
| K150349 | Rapid Hair Removal Pads | Full Power Aed | LDD | Class II | |
| K142398 | Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow | Ellex Medical Pty Ltd | HQF | Class II | |
| K142190 | Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs | PT. Medisafe Technologies | KGO | Class I | |
| K151091 | Vitrea Software Toshiba Package, VSTP-001A | Toshibamedical Systems Corporation | LLZ | Class II | |
| K151014 | Aura DR 43C-AG flat panel detector | Abyzr Co., Ltd. | MQB | Class II | |
| K150919 | ArgenZ Esthetic Plus | The Argen Corporation | EIH | Class II | |
| K150367 | Neodent Implant System | Jjgc Industria E Comercio de Materiais Dentarios S | NHA | Class II | |
| K150321 | EVOS Lumbar Interbody System | Cutting Edge Spine | MAX | Class II | |
| K150084 | Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector | Medtronic, Inc. | PIF | Class II | |
| K142468 | Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System | Cardiac Insight, Inc. | DSH | Class II | |
| K151572 | Penumbra Smart Coil | Penumbra Inc. | HCG | Class II | |
| K151566 | Abbott ARCHITECT Total T4 Calibrators | Abbott Medical | JIT | Class II | |
| K151340 | HARMONIC Focus Long Shears + Adaptive Tissue Technology | Ethicon Endo-Surgery Inc | LFL | Unclassified | |
| K150912 | Houva-NET Control System | National Biological Corp. | FTC | Class II | |
| K150834 | Atrax Anterior Cervical Plating System | Xtant Medical Holdings, Inc. | KWQ | Class II | |
| K150590 | CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear, | Contamac Ltd. | LPL | Class II | |
| K143719 | Aeroneb USB Contoller System | Aerogen Ltd. | CAF | Class II | |
| K143355 | The Simple Locking IntraMedullary (SLIM) System | Orthopediatrics Canada ULC | HSB | Class II | |
| K143345 | SIGNA Pioneer | GE Healthcare Japan Corporation | LNH | Class II | |
| K143275 | IOLMaster700 | Carl Zeiss Meditec Inc | HJO | Class II | |
| K143213 | INOmax DSIR Plus MRI | Ino Therapeutics/Ikaria | MRN | Class II | |
| K142005 | SpineFab Vertebral Body Replacement (VBR) System | Oxford Performance Materials, Inc. | MQP | Class II | |
| K151755 | OASYS(r) System | Stryker Corp. | NKG | Class II | |
| K151581 | Leva Spacer System | Spine Wave Inc | MAX | Class II | |
| K151451 | Aplio 500/400/300 Diagnostic Ultrasound System V6.0 | Toshibamedical Systems Corporation | IYN | Class II | |
| K151143 | EndoLIF On-Cage | Joimax GmbH | MAX | Class II | |
| K151037 | GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle | ConMed Corporation | MBI | Class II | |
| K150655 | OIC Intramedullary Nail System | The Orthopaedic Implant Company | HSB | Class II | |
| K150484 | Penguin In-Line Warmer | Creche Innovations | LGZ | Class II | |
| K150313 | Ablation Confirmation | Neuwave Medical, Inc. | LLZ | Class II | |
| K143656 | StarCeram® Z-Nature, StarCeram® Z-Smile | H.C. Starck Ceramics GmbH | EIH | Class II | |
| K143340 | Powder Free Vinyl Patient Examination Gloves, Yellow Color | Zibo Ling Yun Medical Products Co., Ltd. | LYZ | Class I | |
| K142799 | Model BT-220L and BT-220C | Bistos co., Ltd. | HGM | Class II | |
| K142764 | KYOLING CPR Mask with Oxygen Port and Without Oxygen Port | Hangzhou Jinlin Medical Appliances Co., Ltd. | CBP | Class II | |
| K141725 | Bongold Bone Graft Material | Beijing Allgens Medical Science & Technology Co, L | MQV | Class II |