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 |
|---|---|---|---|---|---|
| K070630 | Health Line International Corporation's Primary IV Solution Administration Set with Check Valve | Health Line International Corporation (Hlic) | FPA | Class II | |
| K070623 | Pharmapac Lubricating Jelly | Pharmapac, LLC | NUC | Class II | |
| K070549 | Straumann P.004 Rc Gold Abutment | Straumann USA, LLC | NHA | Class II | |
| K070419 | Opaciden Opa Reagent Strips | Hach Company | JOJ | Class II | |
| K072353 | Portable Ecscope | Dyansys, Inc. | DPS | Class II | |
| K072285 | Aloka Ssd-Alpha 7 Ultrasound System | Aloka Co., Ltd. | ITX | Class II | |
| K072217 | ECG-1250A Series Cardiofax S and ECG-1350A Series Cardiofax M | Nihon Kohden America Inc | DPS | Class II | |
| K072147 | Den Tek Comfort Fit Nightguard | Den Tek Oral Care, Inc. | OBR | Unclassified | |
| K072132 | Ldr Spine Roi-T System | Ldr Spine USA | MQP | Class II | |
| K072106 | 150W Ceralas D 980Nm Diode Laser | Biolitec, Inc. | GEX | Class II | |
| K071848 | Ips Inline Pom System | Ivoclar Vivadent, Inc. | EIH | Class II | |
| K071846 | Modification to Ez Huber Safety Infusion Set | PFM Medical GmbH | FPA | Class II | |
| K071555 | Fortagen Oral Membrane | Organogenesis, Inc. | NPL | Class II | |
| K071551 | Quickbridge Tm Cylinder and Cap | ZimVie US Corp LLC | NHA | Class II | |
| K071538 | Arrow, Arrowg+ard and Arrowg+ard Blue Plus Pressure Injectable Central Venous Catheter | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | Class II | |
| K071427 | Diamondback 360 Degree Orbital Atherectomy System for Treatment of a-V Shunt Stenosis | Cardiovascular Systems Incorporated | MCW | Class II | |
| K071072 | Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination Glove | Shanghai China Star Corp | LZA | Class I | |
| K070579 | Storz Slx-F2 Storm Touch | Karl Storz Endoscopy-America, Inc. | LNS | Class II | |
| K070206 | Diagnostic Hybrids D3 Dfa Varicella-Zoster Virus Identification Kit, 01-020000 | Ortho-Clinical Diagnostics, Inc. | GQW | Class II | |
| K070057 | Easyra Clinical Chemistry Analyzer | Medica Corp. | CGA | Class II | |
| K063453 | Vertefix Pedicle Screw Spinal System | Elite Surgical Supplies (Pty) Ltd | MNI | Class II | |
| K072266 | Acuson P50 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | ITX | Class II | |
| K072205 | Visage Pacs/cs, Release Version 5.0 | Mercury Computer Systems, Inc. | LLZ | Class II | |
| K072088 | Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable Endosheath Systems | Cogentix Medical, Inc. | EOX | Class II | |
| K072075 | Modification to Ge Logiq A3 | General Electric Co. | IYN | Class II | |
| K072073 | Vision-Sciences ENT-5000 and ENT-5100 Video ENT Scope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor | Cogentix Medical, Inc. | EOB | Class II | |
| K072047 | Mhi-Tm2000 Linear Accelerator System | Mitsubishi Heavy Industries, Ltd. | IYE | Class II | |
| K071852 | Aap Aps System | AAP Implantate AG | KTT | Class II | |
| K071367 | Flexcel Carotid Shunt (Inlying), Model 2020-05 | LeMaitre Vascular Inc. | MJN | Class II | |
| K070661 | Vitalcor Featherweight Vascular Clamps | Vitalcor, Inc. | DXC | Class II | |
| K063635 | Sbi Forefoot Set | Small Bone Innovations, Inc. | HWC | Class II | |
| K071806 | Eclos Computed Tomography X-Ray System | FUJIFILM Healthcare Americas Corporation | JAK | Class II | |
| K071492 | Firstview | Riverain Technologies | LLZ | Class II | |
| K071485 | Tpc Advancecam Intra Oral Camera System, Model Aic 888 | TPC Advanced Technology, Inc. | EIA | Class I | |
| K070338 | Rainbow, Rainbow Light,rainbow Blue, Rainbow Plus | Rainbow Communications, Inc. | ILY | Class II | |
| K072196 | Angiodynamics, Inc Morpheus Picc and Procedure Kit | Boston Scientific Corporation | LJS | Class II | |
| K072157 | Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) | GE Healthcare | FMT | Class II | |
| K071751 | Lifesync Adapter, Model Ls-302 | LifeSync Corporation | DSA | Class II | |
| K071656 | Sbi Artfix | Small Bone Innovations, Inc. | HWC | Class II | |
| K071373 | Stryker Spine Xia III Spinal System | Howmedica Osteonics Corp | NKB | Class II | |
| K072210 | Chison, Model 8300 | Chison Medical Imaging Co., Ltd. | IYO | Class II | |
| K071913 | Immunocap Allergen F338, Scallop with Model(s): 14-4895-01 | Phadia AB | DHB | Class II | |
| K071902 | Ams Miniarc Sling System | American Medical Systems, Inc. | PAH | Class II | |
| K071811 | Etoh Flex Reagent Cartridge (Df22) | Siemens Healthcare Diagnostics Inc. | DIC | Class II | |
| K071530 | Karl Storz Video Flexible Video ENT Endoscope System | Karl Storz Endoscopy-America, Inc. | EOQ | Class II | |
| K071476 | Synthes (USA) 2Nd Generation Pelvic C-Clamp | Synthes (USA) Products LLC | JEC | Class II | |
| K071424 | Pmax Newtron Xs | Satelec-Acteon Group | ELC | Class II | |
| K071336 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307 | Possis Medical, Inc. | QEZ | Class II | |
| K071274 | Gso Gs1 Spacer | Gold Standard Orthopedics, LLC | MQP | Class II | |
| K071263 | Nxstage Travel Warmer, Models Tw-400 & Fws-500 | NxStage Medical Inc | KDI | Class II |