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 |
|---|---|---|---|---|---|
| K062636 | Osseotite, Osseotite Ny, Certain, Certain Nt, Prevail, Certain Prevail, Xp, Microminiplant, Dental Implants | ZimVie US Corp LLC | DZE | Class II | |
| K061954 | Artelon Cmc Spacer Arthro | Artimplant AB | KYI | Class II | |
| K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft Substitute | Apatech Ltd. | MQV | Class II | |
| K070716 | Image 1 Video Imaging System with Optional Insufflators Control | Karl Storz Endoscopy-America, Inc. | FET | Class II | |
| K070074 | Lubrina, Model Him-1 | J. Morita USA, Inc. | EFB | Class I | |
| K062149 | Sp02 Sensor Fs and Ps 'Silc-Touch' Series; Sp02 Sensor Fc, Fp and Y Series | International Business Strategies | DQA | Class II | |
| K071362 | Vital Connect 4.1 | Canon Medical Informatics, Inc. | LLZ | Class II | |
| K071235 | Zimmer One Piece Implant, 3.0Mm Angled, Models Zop30a10, Zop30a11 and Zop30a13 | ZimVie US Corp LLC | DZE | Class II | |
| K071193 | Vidar Vision 3000 and 4000 X-Ray Systems | Vidar Systems Corp. | MQB | Class II | |
| K071185 | Modification to: Ambu Neuroline, Disposable Monopolar Needle Electrode | Ambu A/S | GXZ | Class II | |
| K071181 | Direct Digitizer, Regius Model 110 | Konica Minolta Medical & Graphic, Inc. | MQB | Class II | |
| K070862 | Powder Free Nitrile Examination Gloves (Blue, Wihte) | Purtech Cleanroom Products Co., Ltd. | LZA | Class I | |
| K070814 | Modification to Confluent Surgical Micromyst Applicator and Air Pump | Confluent Surgical,Inc | FMF | Class II | |
| K070793 | Sbi Distal Radius Volar Plating System | Small Bone Innovations, Inc. | HRS | Class II | |
| K070692 | Dukal N95particulate Respirator/surgical Face Mask | Dukal Corp. | MSH | Class II | |
| K070651 | Aragon Surgical Lapcap | Aragon Surgical, Inc. | HIF | Class II | |
| K070638 | Theken Atoll Cervico-Thoracic System | Theken Companies LLC | KWP | Class II | |
| K070382 | Vista -S Device | Zimmer Trabecular Metal Technology, Inc. | MQP | Class II | |
| K063042 | Cardiomem Cm 3000-12Bt | Getemed Medizin- und Informationstechnik AG | MWJ | Class II | |
| K062979 | Thyrosampler | Acd Medical Innovation Corp. | FCG | Class II | |
| K061385 | Osstaple, Ossplate, Ossforce | Biomedical Enterprises, Inc. | KWQ | Class II | |
| K071338 | Flex Arm Retractor System | Koros USA, Inc. | GZT | Class II | |
| K070575 | Evicel Application Device | Omrix Biopharmaceuticals, Ltd. | FMF | Class II | |
| K070416 | Neopeep Neonatal Resuscitation Circuit with PEEP | Neoforce Group, Inc. | BYE | Class II | |
| K070264 | 50 Ml Terumo Syringe for Administration of UV Sensitive Medicines, Model Bs-50Lb | Terumo Europe N.V. | FMF | Class II | |
| K062823 | Aos Interstitial Templates, Needles & Accessories | Alpha Omega Services Inc | JAQ | Class II | |
| K062025 | Aspirinworks Test Kit (11-Dehydro Thromboxane B2), Model 12136 | Corgenix, Inc. | OBW | Class II | |
| K071331 | Vitrea Version 4.0 | Canon Medical Informatics, Inc. | LLZ | Class II | |
| K071222 | Infusor Sv and Lv Elastomeric Infusion Devices | Baxter Healthcare Corporation | MEB | Class II | |
| K071216 | Vitros Chemistry Products Crsc Slides, Vitros Chemistry Products Dt Calibrator Kit, Model 680 2721, 195 7927 | Ortho-Clinical Diagnostics, Inc. | JFY | Class II | |
| K071215 | Vitros Chemistry Products Urcr Slides, Vitros Chemistry Products Dt Calibrator Kit, Model 680 2722, 195 7927 | Ortho-Clinical Diagnostics, Inc. | JFY | Class II | |
| K071173 | Resolve Tongs, Small/medium, Resolve Tongs, Medium/large, Model Jt-200D, Jt-100D | Ossur Americans (Formerly the Jerome Group) | HAX | Class II | |
| K071152 | Palomar Erbium Handpiece | Palomar Medical Products, Inc. | GEX | Class II | |
| K071075 | Terumo Digital Blood Pressure Monitor Es-H55a | Terumo Corp. | DXN | Class II | |
| K071018 | Monarch Nasal Implant | Hanson Medical, Inc. | FZE | Class II | |
| K070910 | Sysmex Model Uf1000i | Sysmex America, Inc. | LKM | Class II | |
| K070887 | Endopath Linear Cutters and Staplers and Echelon60 Endoscopic Linear Cutters and Staplers (and Reloads) | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K070825 | Ld8 Digital Wrist Blood Pressure Monitor | Little Doctor (Shanghai) Electronic Manufacturing | DXN | Class II | |
| K070739 | Allient Sorbent Hemodialysis System, Model# 1500 | Renal Solutions, Inc. | FKT | Class II | |
| K070585 | Accu-Chek Performa System | Roche Diagnostics GmbH | NBW | Class II | |
| K070568 | Dio Protem Implant System | Dio Department Dsi, Inc. | DZE | Class II | |
| K070561 | Kmedic Internal/external Fixation Devices | Teleflex Medical | HTY | Class II | |
| K070547 | Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) | Terumo Europe N.V. | FPA | Class II | |
| K070408 | Duramax Reusable Oximetry Sensor | Medtronic, Inc. | DQA | Class II | |
| K070327 | Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch Snorinator | Sybron Dental Specialties, Inc. | LRK | Class II | |
| K070239 | Maximed Exichek Td-4224 Blood Glucose Monitoring System | Exir Pharmaceutical Co. | NBW | Class II | |
| K070070 | Ascent Dental Cleanser | Cao Group, Inc. | LBH | Class II | |
| K070014 | Auto Detect for Telaheart Dr200/e-a | North East Monitoring, Inc. | MWJ | Class II | |
| K063868 | Masstrak Immunosuppressants Kit | Waters Corporation | MLM | Class II | |
| K063661 | Renu Reprocessed Nellcor Oxysensor, Models D-20 and I-20 | Renu Medical, Inc. | NLF | Class II |