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 |
|---|---|---|---|---|---|
| K070242 | Soundstar 3D Ultrasound Catheter, Model M-5723-05 | Biosense Webster Inc | OBJ | Class II | |
| K070003 | Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and Pre-Attached) | Medcomp | LJT | Class II | |
| K060968 | Stasis - I, II and III; Serathan - a, B; Intrin - Ea, Si Calcium Chloride 0.02M; Fibrinogen Control-Normal, Low | Wortham Laboratories, Inc. | GIZ | Class II | |
| K071068 | Biograph 6 Truepoint, Model Biograph 6 - P/n 10238197 | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K071000 | Myrian | Intrasense | LLZ | Class II | |
| K070427 | Dupel Transport Iontophoresis System | Empi | EGJ | Class II | |
| K070147 | Intergro Oral | ZimVie US Corp LLC | NUN | Class II | |
| K071092 | Asnis Micro Cannulated Screw | Howmedica Osteonics Corp | HWC | Class II | |
| K071073 | Solar 8000 and Transport Pro with Patient Data Module | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K071041 | Coaguchek Xs Plus System | Roche Diagnostics GmbH | GJS | Class II | |
| K070883 | Duracon X3 Cs Tibial Insert | Howmedica Osteonics Corp | MBH | Class II | |
| K070860 | Microscan Synergies Plus Gram-Positive Mic/combo Panels with Clindamycin | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K070677 | Colorise | Zhermack S.p.A. | ELW | Class II | |
| K070646 | Adhese One | Ivoclar Vivadent, Inc. | KLE | Class II | |
| K070591 | Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic Teeth | Union Dental S.A./Unidesa.Odi | ELM | Class II | |
| K070363 | Fetch Aspiration Catheter | Possis Medical, Inc. | QEZ | Class II | |
| K070347 | Allofix Push-in Anchor | Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | HWC | Class II | |
| K070318 | Skippi Powered Wheelchair for Children | Otto Bock Healthcare LP | ITI | Class II | |
| K070313 | Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator System | Misonix, LLC | LFL | Unclassified | |
| K063693 | Forsure One Step Fecal Occult Blood (Fob) Screen Card Test | New Bay Bioresearch Co., Ltd. | KHE | Class II | |
| K063638 | Modification to Proxis System, Model Eps 101 | Abbott Medical | DQY | Class II | |
| K063634 | Rtr Syringe | Septodont | LYC | Class II | |
| K062724 | Accupulse Pulse Oximeter | Eagle Medical Equipment Co. | DQA | Class II | |
| K062572 | Craniotech Bone Transport Reconstruction Plate | Custom Scientific | MQN | Class II | |
| K062011 | Modification to Flowscreen | Viasys Healthcare GmbH | BTY | Class II | |
| K071154 | Superstar 0.35T MRI System | Neusoft Medical Systems Co., Ltd. | LNH | Class II | |
| K071037 | Spy Intra-Operative Imaging System, Model Sp2000 | Novadaq Technologies ULC | IZI | Class II | |
| K071015 | Opdima Digital Mammographic X-Ray System | Siemens Medical Solutions USA, Inc. | IZL | Class II | |
| K070821 | Powdered Natural Rubber Latex Examination Gloves (Protein Label Claim) 200 Micrograms or Less of Total Water Extractable | Medtexx Manufacturing Sdn. Bhd. | LYY | Class I | |
| K070702 | Fusion Resin Cement and Core Kit | Denali Corporation | EBF | Class II | |
| K070086 | Sensacare Model Saa-102 Arm Type Digital Blood Pressure Monitor | Sensacare, Ltd. | DXN | Class II | |
| K063789 | Wn Synocta Gold Abutment | Straumann USA, LLC | NHA | Class II | |
| K071008 | Reprieve Endovascular Temperature Therapy System | Radiant Medical | NCX | Class II | |
| K070994 | Eagle + Anterior Cervical Plate System | DePuy Spine, Inc. | KWQ | Class II | |
| K070993 | Topas System | American Medical Systems, Inc. | FTL | Class II | |
| K070829 | Synepix 4600 Detector | Analogic Corp. | MQB | Class II | |
| K070693 | Auravue Pit & Fissure Sealant | Denali Corporation | EBF | Class II | |
| K070437 | Pro-Dense Bone Void Filler | Wrightmedicaltechnologyinc | MQV | Class II | |
| K063690 | Colin Press Mate, Model Bp S510 | Omron Healthcare Co., Ltd. | MHX | Class II | |
| K063680 | Sharpoint Pdo (Polydioxanone) Sutures | Surgical Specialties Corp | NEW | Class II | |
| K063584 | Sterling If Screw Eyelet, Model Cid3936 and Sterling Cross-Pin Eyelet, Model Cid3937 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | HWC | Class II | |
| K063454 | Pogs, Model 33C | On Site Gas Systems Inc. | CAW | Class II | |
| K062943 | Polysmith Sleep System, Model Nti5498 | Neurotronics, LLC | OLZ | Class II | |
| K062475 | Lma Stonebreaker Device; Probe Size 1.0Mm, 1.6Mm, 2.0Mm | The Laryngeal Mask Co., Ltd. | FFK | Class II | |
| K062395 | Accu-Chek Smart Pix | Roche Diagnostics GmbH | NBW | Class II | |
| K071162 | Agfa Computed Radiography System with Nx2.x Workstations | AGFA Healthcare Corp. | MQB | Class II | |
| K071134 | Sonosite Maxx Series Diagnostic Ultrasound System | FUJIFILM SonoSite,Inc. | IYO | Class II | |
| K071106 | Endorez Obturation Kit (with Accelerator), Model 403, Endorez Accelerator (Refill), Model 399 | Ultradent Products Inc. | KIF | Class II | |
| K070996 | 4 Fr Single Lumen (Sl) Powerpicc Catheter | C.R. Bard Inc | LJS | Class II | |
| K070830 | Male Natural Rubber Latex Condom (with Coloring and Flavoring) | Karex Industries Sdn Bhd | HIS | Class II |