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 |
|---|---|---|---|---|---|
| K223717 | Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack | STERIS Corporation | FRC | Class II | |
| K223715 | Celerity Incubator | STERIS Corporation | FRC | Class II | |
| K223469 | WallFlex™ Biliary RX Stent System | Boston Scientific Corporation | FGE | Class II | |
| K223258 | TNI Clear-Guard™ 3 angled breathing filter (1545020) | Intersurgical Ltd. | CAH | Class II | |
| K222861 | EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 | Olympus Medical Systems Corp. | EOQ | Class II | |
| K231406 | ClearumTM HS | BELLCO SRL | KDI | Class II | |
| K230761 | TRIGEN META-NAIL Nail System | Smith & Nephew, Inc. | JDS | Class II | |
| K230731 | Zavation ALIF System | Zavation Medical Products, LLC | OVD | Class II | |
| K230536 | Single-use Flexible Rhinolaryngoscope; Digital Video Monitor | Hunan Vathin Medical Instrument Co., Ltd. | EOB | Class II | |
| K223291 | Electronic Blood Pressure Monitor | Shenzhen Pango Medical Electronics Co., Ltd | DXN | Class II | |
| K223067 | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | MUM | Class II | |
| K222822 | VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) | Draegerwerk AG & Co. KGaA | BZE | Class II | |
| K222790 | F65 Laser System | Lumenis Ltd | OAP | Class II | |
| K222144 | IR SLA Type Implant System | Biotem Co., Ltd. | DZE | Class II | |
| K221540 | Synexis Sphere Rx | Synexis, LLC | FRA | Class II | |
| K231145 | Axis Anterior Cervical Plate System | Southern Medical (Pty) Ltd | KWQ | Class II | |
| K230759 | SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) | Bosungmeditech Co., Ltd. | QRK | Class II | |
| K230573 | Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) | Kossan International Sdn Bhd | LYY | Class I | |
| K230567 | OptiVu™ ROSA® MxR | Orthosoft Inc (D/B/A Zimmer Cas) | SBF | Class II | |
| K230112 | CAC Software | Imbio, Inc. | JAK | Class II | |
| K223518 | iOrtho | Shanghai EA Medical Instruments Co., Ltd. | PNN | Class II | |
| K223517 | Clear Aligner | Wuxi EA Medical Instruments Technologies Limited | NXC | Class II | |
| K201153 | Tisuthes e-PTFE Surgical Patch | Shanghai Suokang Medical Implants Co., Ltd. | OWR | Class II | |
| K231466 | RxSight Insertion Device | RxSight Inc. | MSS | Class I | |
| K231022 | Pounce™ Thrombectomy System | Surmodics, Inc. | QEW | Class II | |
| K230397 | Cut Screw - Percutaneous Compression Screw | GM dos Reis Industria e Comercio Ltda | HWC | Class II | |
| K223669 | SecurePortIV Advanced Catheter Securement Adhesive | Adhezion Biomedical, LLC | NZP | Class II | |
| K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) | Siemens Healthcare Diagnostics Inc. | CIG | Class II | |
| K221888 | Genadyne Hybrid Foam Dressings | Genadyne Biotechnologies, Inc. | OMP | Class II | |
| K213754 | SpiroHome Personal, SpiroHome Clinic | Inofab Saglik Teknolojileri A.S | BZG | Class II | |
| K223361 | Bmr 1900 Phisio | Corcym Inc. | DTN | Class II | |
| K231368 | Bemer Therapy System Evo | BEMER Int. AG | NGX | Class II | |
| K231359 | RODIN™ Expandable Lumbar Cage System | CTL Medical Corporation | MAX | Class II | |
| K231347 | BruxZir™ TintEFX Coloring Liquid | Prismatik Dentalcraft, Inc. | EIH | Class II | |
| K231037 | MyKnee UNI-ST | Medacta International SA | JWH | Class II | |
| K230992 | DJF Intravascular Administration Set | Yangzhou Wei de LI Trade Co., Ltd. | FPA | Class II | |
| K230905 | OrthoPulse 2.0E (OPi2E-100) | Biolux Technology GmbH | PLH | Class II | |
| K230892 | Fixone Biocomposite Anchor | Aju Medical Co., Ltd. | MAI | Class II | |
| K230779 | Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Shanxi Hongjin Plastic Technology Co., Ltd | LZA | Class I | |
| K230776 | Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro) | Shenzhen Lutejiacheng Technology Co., Ltd. | HGX | Class II | |
| K230768 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K230744 | Acumed Acutrak 3 Headless Compression Screw System | Acumed LLC | HWC | Class II | |
| K230728 | JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K230709 | Auryon Atherectomy System | Eximo Medical Ltd | MCW | Class II | |
| K230586 | Renuvion® Micro Handpiece | Apyx Medical Corporation | GEI | Class II | |
| K230512 | Gamma4 System | Stryker Corp. | HSB | Class II | |
| K230505 | Orthopantomograph™ OP 3D LX | Palodex Group Oy | OAS | Class II | |
| K230502 | Ear Pressure Relief Device(Model:ER813B) | Ningbo Albert Novosino Co., Ltd. | MJV | Unclassified | |
| K230293 | TheraFace Mask | Therabody, Inc. | OHS | Class II | |
| K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor | Edwards Lifesciences LLC | DQK | Class II |