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 |
|---|---|---|---|---|---|
| K201286 | 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch | Nurse Assist, LLC | NGT | Class II | |
| K200981 | Mega Plus MIS Spine System | BK Meditech Co., Ltd. | NKB | Class II | |
| K200740 | HD Video Rhino Laryngoscope | Karl Storz Endoscopy-America, Inc. | EOB | Class II | |
| K200359 | NuEra Tight, NuEra Tight EMS | Bios S.r.l. | PBX | Class II | |
| K193264 | Disposable High Speed Air Turbine Handpiece | Ningbo Hpdove Dental Instruments Co., Ltd. | EFB | Class I | |
| K193175 | Lateralized Glenosphere | Medacta Inernational SA | PHX | Class II | |
| K191296 | Pointe Scientific Creatinine Kinase (CK) Reagent Set | Medtest DX | CGS | Class II | |
| K201585 | Monterey AL Interbody System | Stryker Corp. | OVD | Class II | |
| K201567 | Precice® Bone Transport System | NuVasive Specialized Orthopedics, Inc. | HSB | Class II | |
| K200592 | GS Medical AnyPlus PEEK Cage System | GS Medical Co., Ltd. | ODP | Class II | |
| K193626 | Masimo Rad-97 Pulse CO-Oximeter and Accessories | Masimo Corporation | MWI | Class II | |
| K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik a/S | QCI | Class II | |
| K201938 | LZI Fentanyl II Enzyme Immunoassay | Lin-Zhi International Inc | DJG | Class II | |
| K201932 | X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) | Careray Digital Medical System Co., Ltd. | MQB | Class II | |
| K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System | CarboFix Orthopedics Inc. | NKB | Class II | |
| K201883 | 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor | Medos International SARL | MBI | Class II | |
| K201619 | EndoTool IV System | Monarch Medical Technologies | NDC | Class II | |
| K201310 | Accipiolx | Maxq AL, Ltd. | QAS | Class II | |
| K201244 | Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices | Transmed7, LLC | KNW | Class II | |
| K201067 | CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed)) | Cupid Limited | HIS | Class II | |
| K201006 | K2M Navigation Instruments | K2M, Inc | OLO | Class II | |
| K200990 | VIDAvision | Vida Diagnostics | JAK | Class II | |
| K200809 | D-Lux+ | Diadent Group International | EBZ | Class II | |
| K193278 | MedSource CathMED IV Catheter | MedSource Labs, LLC | FOZ | Class II | |
| K193207 | TaiChiA | Our United Corporation | IYE | Class II | |
| K193130 | MVP Aligner System | Mvp Aligners, LLC | NXC | Class II | |
| K193082 | Fountain ValveTip Infusion Catheter | Merit Medical Systems, Inc. | KRA | Class II | |
| K192657 | Sterile High-pressure Angiographic Syringes for Single-use | Shenzhen Boon Medical Supply Co., Ltd. | DXT | Class II | |
| K192075 | ProSeal™ Closed System drug Transfer Device (CSTD) | Epic Medical Pte., Ltd. | ONB | Class II | |
| DEN200001 | Cell-Free DNA BCT | Streck LLC | QMA | Class II | |
| K201907 | ClariVein IC | Merit Medical Systems, Inc. | KRA | Class II | |
| K201750 | Pentaray Nav eco High-Density Mapping Catheter | Biosense Webster Inc | MTD | Class II | |
| K201667 | Midmark Extraoral Imaging System (EOIS) | Midmark Corp | OAS | Class II | |
| K201641 | Disposable Laparoscope Trocar | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | GCJ | Class II | |
| K201521 | Medina Anterior Cervical Plate System | Alliance Partners, LLC | KWQ | Class II | |
| K201502 | Vitra 810 | Quantel Medical | HQF | Class II | |
| K201143 | VICRYL Mesh | Ethicon, Inc | FTL | Class II | |
| K201076 | Anchor Dual Lumen Guidewire Catheter | Aqure Medical, Inc. | QJP | Class II | |
| K200890 | Invacare Perfecto2V Oxygen Concentrator | Invacare GmbH | CAW | Class II | |
| K200858 | Mini Sterilizable Tray | Implant Direct Sybron Manufacturing LLC | KCT | Class II | |
| K200353 | ManaFlow | Manamed LLC | JOW | Class II | |
| K200324 | NHancer Rx | IMDS Operations B.V. | DQY | Class II | |
| K193066 | Steripack cases and Tray Systems | AVALIGN TECHNOLOGIES, Inc. | KCT | Class II | |
| K191644 | TK Safety Needle | Anhui Tiankang Medical Technology Co., Ltd. | FMI | Class II | |
| K201952 | CrossGlide ETS Plus | Crossbay Medical | HHK | Class II | |
| K201715 | Smart Toe II, X Fuse | Stryker Corp. | HTY | Class II | |
| K201531 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Hartalega Sdn Bhd | LZA | Class I | |
| K201530 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) | Hartalega NGC Sdn Bhd | LZA | Class I | |
| K201251 | CarboClear Navigated Instruments | CarboFix Orthopedics Inc. | OLO | Class II | |
| K201240 | Mariner Cap System | SeaSpine Orthopedics Corporation | OWI | Class II |