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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K073526 | Amicas Vision Series Pacs, Model 5.5 | Amicas, Inc. | LLZ | Class II | |
| K073023 | Sterils Single-Use I/a Handpieces | Bausch & Lomb Incorporated | HQC | Class II | |
| K072256 | Hf54 Combination Ultrasound Interferential and Premodulated Stimulation System with Optional Hands-Free Operation, Model | Hill Laboratories | PFW | Class II | |
| K072197 | Powder-Free Latex Examination Gloves - 18 Mils at Finger, Blue Color; 9 and 10 Mils at Finger, Natural Color | Metacure Surgical Gloves Sdn Bhd | LZC | Class I | |
| K071666 | Slendertone Enervive, Model 561 | Bio-Medical Research, Ltd. | NGX | Class II | |
| K080423 | Integre, Model Lp581 | Ellex Medical Pty Ltd | HQF | Class II | |
| K080272 | Atlantis Pvimaging Catheter, Model H749364560 | Boston Scientific Corporation | ITX | Class II | |
| K080087 | Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, Models Lite, Basic, Pro, II, II Pro and Vascular | Edan Instruments, Inc. | KNG | Class II | |
| K073709 | Modification to Viewmate System | Abbott Medical | IYN | Class II | |
| K073605 | Atricure Coolrail Linear Pen | AtriCure, Inc. | OCL | Class II | |
| K073515 | Trans1 Facet Screw | Trans1 Incorporated | MRW | Unclassified | |
| K073064 | Graftys Bcp | Graftys | MQV | Class II | |
| K073041 | Relieva and Relieva Acella Sinus Balloon Catheter | Acclarent Inc | KAM | Class I | |
| K073008 | Kfh Energy, Model: E1 | Kingfisher Healthcare NV | GZJ | Class II | |
| K063443 | Draeger Alcotest 6510 | Drager Safety | DJZ | Class I | |
| K080422 | 5 Megapixel Monochrome Lcd Monitor, Model Radiforce Gs520 | Eizo Nanao Corporation | LLZ | Class II | |
| K080406 | Ipulse, Model I400 | Cyden Limited | GEX | Class II | |
| K080349 | Kimba Mini | Signus Medizintechnik GmbH | MQP | Class II | |
| K080258 | Modification to Endius Minit Posterior Cervical and Upper Thoracic Fixation System | Endius, Inc. | NKB | Class II | |
| K080120 | Hfo Shoulder Coil | Philips Medical Systems MR Finland | MOS | Class II | |
| K080098 | Mrj Extended | Paramed S.r.l. | LNH | Class II | |
| K073484 | Ethicon Endo Surgery Sheath and Articulating Accessory Channel - Gastroscope, Model In0431; Colonoscope, Model In0432 | Ethicon Endo-Surgery Inc | ODC | Class II | |
| K073475 | System Plus | Continental Dental Laboratory | ELW | Class II | |
| K073062 | Omni-Vue System | Genesis Digital Imaging, Inc. | LLZ | Class II | |
| K072425 | Jne Implant System | GC America Inc. | DZE | Class II | |
| K063385 | Durex Play Massage Gel Lubricant | Ssl Americas, Inc. | NUC | Class II | |
| K063157 | Merries K-Phate Bone Graft Substitute | Merries International, Inc. | MQV | Class II | |
| K080415 | Device Modification to Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | DYB | Class II | |
| K080387 | Hu II / Hs II Fixture System | OSSTEM Implant Co., Ltd. | DZE | Class II | |
| K080318 | Alma Laser Nir Module | Alma Lasers Ltd. | ILY | Class II | |
| K080286 | Cementable Abuntments; Temporary Copings; Protective Caps | Straumann USA, LLC | NHA | Class II | |
| K073506 | Luminex Lx 100/200 Instrument | Luminex Corporation | NSU | Class II | |
| K073488 | Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model Dzxxx | Diazyme Laboratories, Inc. | MSJ | Class I | |
| K073476 | Compact Auto-Safety Injector (Casi) | Medical House (Asi) Limited | KZH | Class II | |
| K073374 | Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set | William Cook Europe ApS | DTK | Class II | |
| K073345 | Certain Contoured Margin Ceramic Abutment | ZimVie US Corp LLC | NHA | Class II | |
| K073286 | Gender Solutions Natural-Knee Flex System | Zimmer GmbH | JWH | Class II | |
| K073247 | Us/ss/gs System | OSSTEM Implant Co., Ltd. | DZE | Class II | |
| K073161 | Replus Dental Implants (Ha) | Implant Direct, LLC | DZE | Class II | |
| K073028 | Venowave Models Vw5-6, Vw5-10, Vw5-20 and Vw5-30 | Venowave, Inc. | JOW | Class II | |
| K072719 | Convoy Advanced Delivery Sheath | Boston Scientific Corporation | DYB | Class II | |
| K072481 | Jet Port Plus Hp Catheter System | PFM Medical GmbH | LJT | Class II | |
| K072212 | Jet-X Bar System Clamps, Bars and Posts-Mr Safe | Smith & Nephew, Inc. | KTT | Class II | |
| K072144 | Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software - Administrator | Abbott Medical | MEA | Class II | |
| K071869 | Tens/if 14 | Emsi | GZJ | Class II | |
| K071763 | Amadeus Adaptive Compression Therapy | ConvaTec Limited | JOW | Class II | |
| K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | KWA | Class III | |
| K080171 | Sanarus Incore Rotational Core Biopsy Device, Models Cb3010, Cb3012 | Sanarus Medical, Inc. | KNW | Class II | |
| K080155 | Modification To:intuitive Surgical Stereo View Endoscopic System | Intuitive Surgical, Inc. | GCJ | Class II | |
| K073470 | Avs Pl Peek Spacers, Models 48351Xxx and 48353Xxx | Howmedica Osteonics Corp | MAX | Class II |