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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K201002 | Safey Pocket Spirometer | Safey Medical Devices Pvt, Ltd. | BZG | Class II | |
| K200832 | Safey Peak Flow Meter | Safey Medical Devices Pvt, Ltd. | BZH | Class II | |
| K200678 | PENTAX Medical Video Bronchoscope EB-J10 Series | PENTAX of America, Inc. | EOQ | Class II | |
| K200280 | MEDRAD Imaging Bulk Package Transfer Spike | Medrad, Inc. | PQH | Class II | |
| K200142 | SpeediCath Soft | MEDLINE INDUSTRIES, LP - Northfield | GBM | Class II | |
| K200082 | BD Univia RightFit Enteral Extension Sets and Transitional Adapters | MPS Medical Inc. | PIF | Class II | |
| K200060 | Reprocessed NRG Transseptal Needle | Innovative Health, LLC. | QLZ | Class II | |
| K193660 | OSSIOfiber™ Compression Screws | OSSIO, Ltd. | HWC | Class II | |
| K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | QBS | Class II | |
| K193321 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | LXC | Unclassified | |
| K193283 | AI-Rad Companion Prostate MR | Siemens Medical Solutions USA, Inc. | QIH | Class II | |
| K192663 | Joimax Intracs System | Joimax GmbH | OLO | Class II | |
| DEN200015 | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | Roche Molecular Systems Inc | QLX | Class II | |
| K201760 | Zoom 14 Guidewire | Scientia Vascular | DQX | Class II | |
| K201361 | Pneumoclear | Novanta Medical GmbH | HIF | Class II | |
| K201040 | Bioflux Software II | Biotricity | DSH | Class II | |
| K200959 | Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling | Biomet U.K., Ltd. | LZO | Class II | |
| K200824 | Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown | Cardinal Health200, LLC | FYA | Class II | |
| K200518 | Pitkar External Fixation System - Rail Mechanism | S.H.Pitkar Orthotools Pvt., Ltd. | KTT | Class II | |
| K200504 | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote | Med-el Elektromedizinische Geraete, GmbH | PFO | Class II | |
| K200413 | Symphony | AROA Biosurgery Inc. | KGN | Unclassified | |
| K193647 | Superpipe Angiographic Catheter | Suzhou Hengrui Disheng Medical Co., Ltd. | DQO | Class II | |
| K182759 | BoniPlus Dental G-Mesh System | Montjade Engineering Co., Ltd. | JEY | Class II | |
| K201794 | Jade | OrbusNeich Medical (Shenzhen) Co., Ltd. | LIT | Class II | |
| K201792 | TRUSELECT Microcatheter | Boston Scientific Corporation | KRA | Class II | |
| K201616 | SyMRI | Syntheticmr AB | LNH | Class II | |
| K201434 | Connected OR Hub with Voice Control, Connected OR Hub with Device Control | Stryker Corp. | GCJ | Class II | |
| K200805 | Neocis Guidance System (NGS) with Patient Splints | Neocis Inc. | PLV | Class II | |
| K200801 | Quantisal Oral Fluid Collection Device | Immunalysis Corporation | PJD | Class II | |
| K192681 | Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) | Jiangsu Kangbao Medical Equipment Co., Ltd | FPA | Class II | |
| K192481 | AccelFix Lumbar Plate System | L&K Biomed Co.,Ltd. | KWQ | Class II | |
| K201280 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K201132 | Arthrex Compression Screws | Arthrex GmbH | HRS | Class II | |
| K200785 | Stratum™ Reduced Size Foot Plating System | Medartis AG | HRS | Class II | |
| K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland Ltd. | BZG | Class II | |
| K200242 | StaClear Syringe | Tribofilm Research, Inc. | QLY | Class II | |
| K201479 | DemeMASK | Demetech Corp. | FXX | Class II | |
| K201321 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System | DePuy Synthes | HRS | Class II | |
| K201293 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd | FGB | Class II | |
| K200927 | Transept Cervical Plate System | Neurostructures, Inc. | KWQ | Class II | |
| K200849 | Tempus LS - Manual | Remote Diagnostic Technologies, Ltd. A Philips Company | LDD | Class II | |
| K200742 | JUSHA-CP610 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K200643 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K200496 | Aer X | 3B Medical Inc | CAW | Class II | |
| K193625 | Disposable Temperature Probe | Shenzhen Changke Connect Electronics Co., Ltd. | FLL | Class II | |
| K193601 | Single Use Electrosurgical Knife | Micro-Tech (Nanjing) Co., Ltd. | GEI | Class II | |
| K193575 | Arthrex SutureTape | Arthrex GmbH | GAT | Class II | |
| K192669 | Extremely Thin 003, ZERO ZERO THREE | Okamoto U.S.A., Inc. | HIS | Class II | |
| K201796 | 1717Scv, 1717Sgv | Rayence Co., Ltd. | MQB | Class II | |
| K201713 | AVVIGO Guidance System | Boston Scientific Corporation | DQK | Class II |