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 |
|---|---|---|---|---|---|
| K220387 | Disposable Blood Lancets | Suzhou Kyuan Medical Apparatus Co., Ltd. | QRL | Class II | |
| K212273 | Cross Protection ResQ300 Plus Surgical Face Mask | Cross Protection M Sdn Bhd | FXX | Class II | |
| K212033 | Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle | Shandong Zhushi Pharmaceutical Group Co., Ltd | FMF | Class II | |
| K210678 | implaFit® hip stems | implantcast GmbH | LZO | Class II | |
| K222169 | FairFix Adjustable Button System | Medacta International SA | MBI | Class II | |
| K221852 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Shockwave Medical, Inc. | PPN | Class II | |
| K221190 | ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K220433 | syngo Application Software (VE21) | Siemens Medical Solution USA, Inc. | LLZ | Class II | |
| K220329 | G-Cam | Graphenano Dental, SL | EBF | Class II | |
| K213937 | Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution | O&M Halyard, Inc. | LZA | Class I | |
| K213426 | HemosIL ReadiPlasTin | Instrumentation Laboratory Co. | GJS | Class II | |
| K213026 | Clear Aligner | Shenzhen Meiming Dentistry Technology Co., Ltd. | NXC | Class II | |
| K212385 | YUWELL Finger Pulse Oximeter | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | DQA | Class II | |
| K221302 | Recon Steerable Sheath | Serpex Medical, Inc. | EOQ | Class II | |
| K220163 | Her-2, ER, PR IHControls | Boston Cell Standards Inc | NJW | Class II | |
| K214095 | da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments | Intuitive Surgical, Inc. | NAY | Class II | |
| K213845 | HeRO Graft | Merit Medical Systems, Inc. | DSY | Class II | |
| K213527 | Forum | Carl Zeiss Meditec Inc | NFJ | Class II | |
| K212790 | XLase Plus | Biotec Italia, SRL | GEX | Class II | |
| K222145 | EzDent-i / E2 / Prora View/ Smart M Viewer | Ewoosoft Co., Ltd | LLZ | Class II | |
| K222082 | aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices | Carlsmed, Inc. | MAX | Class II | |
| K221466 | IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 | Shenzhen Century Dongyuan Technology Co. Ltd | OHT | Class II | |
| K221131 | Tasso+ | Tasso Inc | FMK | Class II | |
| K221126 | Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets | Owen Mumford Limited | FMK | Class II | |
| K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | OVE | Class II | |
| K221027 | Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) | Allmed Medical (Hubei) Protective Products Co., Ltd | FYC | Class II | |
| K220835 | Arkligners | Arklign Laboratories | NXC | Class II | |
| K220680 | Denture Base Polymers | Shandong Huge Dental Material Corporation | EBI | Class II | |
| K220434 | Blue Eye (TS-905) | The Standard Co., Ltd. | PLL | Class II | |
| K220403 | Vibe SF Self-Fitting Hearing Aid | Wsaud A/S | QDD | Class II | |
| K220385 | Intense Pulsed Light Equipment | Beijing Globalipl Development Co., Ltd. | ONF | Class II | |
| K220349 | TeraRecon Neuro | Terarecon, Inc. | LLZ | Class II | |
| K220090 | Visibly Digital Acuity Product | Visibly | QTO | Class I | |
| K213686 | SKOUT Software | Iterative Scopes, Inc. | QNP | Class II | |
| K202739 | Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System | Bioland Technology Ltd. | NBW | Class II | |
| K202508 | Hemo-Lyte C Cartridge | Di-Chem, Inc. | KPO | Class II | |
| K202461 | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System | Smisson-Cartledge Biomedical, LLC | LGZ | Class II | |
| K222414 | Tera Harz Denture | Graphy Inc. | EBI | Class II | |
| K222161 | Arthrex Knotless FiberTak Biceps Suture Anchor | Arthrex GmbH | MBI | Class II | |
| K221737 | InstaFill Graft Delivery System, SIGNIFY Bioactive | Globus Medical, Inc. | FMF | Class II | |
| K221385 | LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) | Ovesco Endoscopy AG | PLL | Class II | |
| K221177 | Erbe's Tubing/Cap Sets | Erbe USA Inc | OCX | Class II | |
| K220910 | Medical image processing software | Hangzhou Deepwise & League of PHD Technology Co., Ltd. | JAK | Class II | |
| K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker Corp. | MEH | Class II | |
| K220648 | OMF ASP System | Vha Dean | DZJ | Class II | |
| K220472 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | NEY | Class II | |
| K220308 | Patient Monitor: RespArray | Edan Instruments, Inc. | MHX | Class II | |
| K220050 | KLS Martin IPS Distraction | KLS-Martin L.P. | MQN | Class II | |
| K213713 | AI-Rad Companion (Pulmonary) | Siemens Healthcare GmbH | JAK | Class II | |
| K212361 | Novo | Pathai | QKQ | Class II |