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 |
|---|---|---|---|---|---|
| K061991 | Plateletworks Arachidonic Acid, Model Pw-Aca | Helena Laboratories, Corp. | GHR | Class II | |
| K061775 | Wako L-Type Creatinine-M Test, and Wako Creatinine Calibrator | FUJIFILM Healthcare Americas Corporation | JFY | Class II | |
| K061629 | Certain Prevail Dental Implant | ZimVie US Corp LLC | DZE | Class II | |
| K061497 | Syrex Heparin Lock Flush Syringe, 1 Unit/ml & 2 Units/ml | Excelsior Medical LLC | NZW | Class II | |
| K070266 | 560 High Definition Camera System | Smith & Nephew, Inc. | GCJ | Class II | |
| K070076 | Powder Free Vinyl Patinet Examination Gloves, Clear (Non-Colored) | Jiangsu Cureguard Glove Co., Ltd. | LYZ | Class I | |
| K063713 | Ams Smart Sling System | American Medical Systems, Inc. | OTN | Class II | |
| K063639 | Aquamantys Ss4.0 Bipolar Sealer, Model 23-121-1 | Medtronic Navigation, Inc | GEI | Class II | |
| K063596 | Perioglas Putty-Bioactive Bone Graft Gel | Novabone Products, LLC | LYC | Class II | |
| K063540 | BIPAP Autosv | Respironics, Inc. | MNS | Class II | |
| K063531 | Series 3 Lotus Laparoscopic Ultrasound Surgery System | SRA Developments Ltd | LFL | Unclassified | |
| K063488 | Maxo2 Cu | Maxtec, LLC | CCL | Class II | |
| K062444 | Hi-Slip and Hi-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit | Oasis Medikal Urunler Kimya Sanayi ve Tic A.S. | EZD | Class II | |
| K062432 | Nanotite Dental Implants | ZimVie US Corp LLC | DZE | Class II | |
| K062388 | Anesthesia Information and Digital-Drug Management System | Docusys | BSZ | Class II | |
| K070236 | Sbi Lateral Radio Capitellum | Small Bone Innovations, Inc. | JDB | Class II | |
| K070189 | Accu-Chek Ultraflex Infusion Set | Disetronic Medical Systems | FPA | Class II | |
| K062952 | C300 Series Air Nebulizer Compressor | Choice Smart Health Care Co., Ltd. | CAF | Class II | |
| K070102 | Sopro 162 Camera | Sopro | GCJ | Class II | |
| K070037 | Powder Free Vinyl Patient Examination Glove | Shijiazhuang Lianhe Shunda Plastic Products Co., L | LYZ | Class I | |
| K063704 | Britewhite Teeth Whitening System, Model Bw1101 | Beks Incorporated | EEG | Class I | |
| K063614 | Altra Fx Hip System | Biomet Manufacturing Corp | KWA | Class III | |
| K063533 | BIPAP Synchrony | Respironics, Inc. | MNS | Class II | |
| K062756 | Pathiam Imaging Software for Her2/neu | Bioimagene, Inc. | NOT | Class II | |
| K062565 | Status Ds Nicotine, Accusign Nicotine, Biosign Nicotine | Princeton BioMeditech Corp. | MKU | Class I | |
| K062527 | Blue Powder Free Latex Examination Gloves, Non-Sterile | Multisafe Sdn Bhd | LYY | Class I | |
| K070246 | Down Pak | Endo Twinn B.V. | EKM | Class I | |
| K070088 | Assure 4 Blood Glucose Monitoring System | Apex Biotechnology Corp. | NBW | Class II | |
| K070030 | Powder Free Vinyl Patient Examination Glove | Super Safe Plastic Products Co., Ltd. | LYZ | Class I | |
| K063523 | Zimmer One Piece Implant, 3.7Mm and 4.7Mm, Models Zop37s10, 11, 13, 16; Zop37a10, 11, 13, 16; Zop47s10, 11, 13, 16; Zop4 | ZimVie US Corp LLC | DZE | Class II | |
| K063520 | Roche Total Mycophenolic Acid Assay, Calibrators and Controls | Roche Diagnostics GmbH | OAV | Class II | |
| K063517 | Healadex-P | Healagenics, Inc. | FRO | Unclassified | |
| K063349 | Cormatrix Patch for Cardiac Tissue Repair | Cormatrix Cardiovascular, Inc. | DXZ | Class II | |
| K063236 | Beta-Powder | Brainbase Corporation | KOJ | Class II | |
| K062689 | Sidestream Plus | Respironics, Inc. | CAF | Class II | |
| K062567 | Rightest Blood Glucose Monitoring System | Bionime Corporation | NBW | Class II | |
| K062464 | Modification to Autocon II 400 Electrosurgical Generator | Karl Storz Endoscopy-America, Inc. | GEI | Class II | |
| K062445 | Monitoring Ear Thermometer, Model Btm-D1a | Rio Flexon Technology Co., Ltd. | FLL | Class II | |
| K062437 | Disposable Hypodermic EMG Needle Electrode Technomed Europe Version and Private Labeled | Technomed Europe | IKT | Class II | |
| K061379 | Infinity Telesmart Telemetry System | Draeger Medical Systems, Inc. | MHX | Class II | |
| K070323 | Temporary Limb Salvage Shunt | Vascutek, Ltd. | DXC | Class II | |
| K070161 | Quattro Catheter Model Ic4593 | Alsius Corp. | NCX | Class II | |
| K070150 | Vascupuncture Picc Guidewire | Neometrics, Inc. | DQX | Class II | |
| K070131 | Radiforce Gx220 and Gs220 Monochrome Lcd Monitors | Eizo Nanao Corporation | LLZ | Class II | |
| K070128 | CO2 Easy | Westmed Inc | CCK | Class II | |
| K063655 | Dimension Vista; Cer Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control Medium, Protein 1 Control High | Siemens Healthcare Diagnostics Inc. | CHN | Class II | |
| K063650 | Ventilator with Respiratory Mechanics, Model 840 | Medtronic, Inc. | CBK | Class II | |
| K063425 | Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control Medium, and Protein 1 Control High | Siemens Healthcare Diagnostics Inc. | DGC | Class II | |
| K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | CBK | Class II | |
| K063183 | Prisma M10 Pre Set | Gambro Renal Products | KDI | Class II |