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 |
|---|---|---|---|---|---|
| K221468 | Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants | Acuitive Technologies | MAI | Class II | |
| K213757 | Endocem MTA Premixed Regular | Maruchi | KIF | Class II | |
| K230207 | ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K230196 | syngo.via View&GO VA40A | Siemens Healthcare GmbH | LLZ | Class II | |
| K223859 | Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl | Rhino Health, Inc. | LZA | Class I | |
| K223779 | EMPOWR™ blade stem | Encore Medical, LP | LPH | Class II | |
| K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System | Stryker Leibinger GmbH & Co. KG | OLO | Class II | |
| K223761 | OIC Intramedullary Screw System | The Orthopaedic Implant Company | HWC | Class II | |
| K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF) | AmeriWater LLC. | FIP | Class II | |
| K223439 | SIGNA Victor | GE Healthcare (Tianjin) Company Limited | LNH | Class II | |
| K223387 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K223370 | NeatNick Heel Safety Lancet | Facet Technologies, LLC. | FMK | Class II | |
| K223263 | Prevena Plus 125 Therapy Unit | 3M | QFC | Class II | |
| K223186 | Indigo® Aspiration System – Lightning Bolt Aspiration Tubing | Penumbra Inc. | QEW | Class II | |
| K222341 | Arrow 0.2 Micron Flat Filter, GVS | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | Class II | |
| K222327 | Bloomlife MFM-Pro | Bloom Technologies NV | HGM | Class II | |
| K221875 | Sterilization Pouch and Roll | Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. | FRG | Class II | |
| K213030 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | ODP | Class II | |
| K212635 | Sofjec | Hwajin Medical Co., Ltd. | FMF | Class II | |
| K213629 | Smile | NU Eyne Co., Ltd. | QGL | Class II | |
| K223786 | Orthex External Fixation System | Orthopediatrics Corp | KTT | Class II | |
| K223680 | Eneka Pro | Termosalud | GEX | Class II | |
| K223467 | Disposable Isolation Gown | Nanning Tecbod Biological Technology Co.,Ltd | FYC | Class II | |
| K223438 | TELIGEN System Peripheral Motor Nerve Stimulation Indications | Medos International SARL | PDQ | Class II | |
| K223425 | MD.ai Viewer | Mdai, Inc. | LLZ | Class II | |
| K223413 | Pisces™-SA STANDALONE ALIF Interbody System | Osseus Fusion Systems LLC | OVD | Class II | |
| K223249 | Pro-Tx Endorectal Balloon (PROT-25) | Dxtx Medical Inc. | PCT | Class II | |
| K223208 | Safety Lancet | Suzhou Zhenwu Medical Co., Ltd. | FMK | Class II | |
| K223194 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. | EIH | Class II | |
| K222596 | S90 Exp Series Digital Color Doppler Ultrasound System | Sonoscape Medical Corp. | IYN | Class II | |
| K222513 | Glass Ceramics | Yilink (Tianjin) Biotechnology Co., Ltd. | EIH | Class II | |
| K222129 | Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim | Top Glove Medical (Thailand) Co., Ltd. | LZA | Class I | |
| K221476 | Perifit | X6 Innovations | HIR | Class II | |
| K221474 | PRIMUS Healthcare Sterilizer (Model PSS11-HC) | PRIMUS Sterilizer Company LLC | FLE | Class II | |
| K221452 | DiLumen C1, EZ1 and Tool Mount | Lumendi, LLC | FDF | Class II | |
| K220715 | ARTSMedia In Vitro Culture Medium (AM-IVC Medium) | Artsmedia Denmark ApS | MQL | Class II | |
| K220657 | Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) | Zhejiang Rongsheng Industrial Co., Ltd. | FLL | Class II | |
| K220435 | SEJONG Surgical Gown Soft | Sejong Healthcare Co., Ltd. | FYA | Class II | |
| K213853 | RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large | Smith & Nephew Medical Ltd | OMP | Class II | |
| K230089 | ETHICON LINX® Esophagus Sizing Tool | Torax Medical, Inc. | QJN | Class II | |
| K230073 | Okti | Compumedics Limited | GWQ | Class II | |
| K230063 | G Surgical Marksman Spinal Deformity System | G Surgical Co., Ltd. | NKB | Class II | |
| K223678 | Sterile Syringes for Single Use | Shanghai Kindly Enterprise Development Group Co., Ltd. | FMF | Class II | |
| K223559 | Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) | Nephron SC, LLC. | LZA | Class I | |
| K223338 | Toothsi, Smilealigners | Makeo Healthcare Technologies Private Limited | NXC | Class II | |
| K222073 | VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) | bioMerieux, Inc. | LON | Class II | |
| K222041 | CYGNUS-C Standalone ACIF System | GS Medical Co., Ltd. | OVE | Class II | |
| K221694 | External Drainage System | Jmed(Shenzhen) Technology Limited | JXG | Class II | |
| K221400 | hygh-tec drainage | Creative Balloons GmbH | KNT | Class II | |
| K221223 | extriCARE® 3000 Negative Wound Pressure Therapy System | Alleva Medical Devices | OMP | Class II |