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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K241673 | Denture Base Resin (PN-Denture (Red, White)) | Shenzhen Piocreat 3D Technology Co., Ltd | EBF | Class II | |
| K240385 | Vint | Mediimg Corporation | LLZ | Class II | |
| K240192 | Single-use Extraction Baskets | Scivita Medical Technology Co., Ltd. | LQR | Class II | |
| K231997 | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) | Cure Point Therapeutics, Inc | ILY | Class II | |
| K242812 | NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) | Nb Medical Co., Ltd. | LZA | Class I | |
| K242833 | Legend® Acetabular Shell | Ortho Development Corp. | LPH | Class II | |
| K242779 | Hood (DH-083ST) | FUJIFILM Corporation | FDS | Class II | |
| K242778 | X Sensor (Model: IOS-A15IF, HDI-15DGF) | Qpix Solutions, Inc. | MUH | Class II | |
| K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | STERIS Corporation | ODC | Class II | |
| K242387 | Mobility Scooter (N3473) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | INI | Class II | |
| K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) | Centerline Biomedical | DQK | Class II | |
| K242095 | Access Toxo IgM II | Siemens Healthcare Diagnostics Inc. | LGD | Class II | |
| K242035 | Accure Laser System | Accure Acne, Inc | GEX | Class II | |
| K241971 | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co., Ltd | OHS | Class II | |
| K241569 | syngo Application Software | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K241163 | SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | OBO | Class II | |
| K241153 | Progressive Orthodontics App | Progressive Aligners | PNN | Class II | |
| K240826 | Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter | Sterilmed Inc | NLH | Class II | |
| K240797 | PPH Saliva Collection Kit | Permantis Public Health | QBD | Class II | |
| K240501 | Spark™ Clear Aligner System | Ormco Corporation | NXC | Class II | |
| K240499 | ARTAIRA Arterial Compression Device (AACD01) | Airos Medical Inc | JOW | Class II | |
| K240472 | PBM Hair Therapy Cap | Dongguan Tutamen Metalwork Co.,LTD. | OAP | Class II | |
| K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) | Anhui Deepblue Medical Technology Co., Ltd. | LCX | Class II | |
| K240143 | JDZygoma dental implants | Jdentalcare SRL | DZE | Class II | |
| K234110 | Belun Ring BLR-200 (BLR-200) | Belun Technology Company Limited | DQA | Class II | |
| K233265 | Monotime and Optime R | Peters Surgical | GAM | Class II | |
| K232779 | Quex Ed; Quex S | Qx World, Ltd. | OMC | Class II | |
| K232565 | UriSponge™ | Copan Italia | JSM | Class I | |
| DEN230078 | Versius Surgical System | CMR Surgical Inc. | SCV | Class II | |
| K242515 | uDR 380i Pro | Shanghai United Imaging Healthcare Co., Ltd. | IZL | Class II | |
| K242400 | Dental porcelain powder | Yilink (Tianjin) Biotechnology Co., Ltd. | EIH | Class II | |
| K242389 | EyeGility™ Inserter for Preloaded enVista IOLs | Bausch & Lomb Incorporated | MSS | Class I | |
| K241951 | Lasya-Trinity | BLUECORE Company Co., Ltd. | GEX | Class II | |
| K241735 | ProSeal™ In Line Pump Set (423850) | Epic Medical Pte., Ltd. | ONB | Class II | |
| K241491 | Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed Glenoid | Stryker Corporation (Tornier, S.A.S.) | PHX | Class II | |
| K241430 | EchoMeasure | Icardio.Ai | QIH | Class II | |
| K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT | Quanta System Inc. | GEX | Class II | |
| K240992 | eMVFit (MVF-10M) | Weero Co., Ltd. | IPF | Class II | |
| K240848 | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance | Ambu A/S | FAJ | Class II | |
| K240786 | AutoChamber | Heartlung Corporation | QIH | Class II | |
| K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) | Siemens Healthcare Diagnostics Products Limited | QLU | Class II | |
| K240262 | BTI Interna 3.0 Dental Implant System UnicCa® | B.T.I. Biotechnology Institute, S.L. | DZE | Class II | |
| K233947 | KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System | CTL Medical Corporation | MAX | Class II | |
| K230325 | GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System | Greens Surgicals Pvt., Ltd. | NKB | Class II | |
| K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | OsteoCentric Technologies,Inc | HWC | Class II | |
| K242029 | Trap Easy | H.S. Hospital Service S.p.A. | KNW | Class II | |
| K242021 | The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. | Thermo Fisher Scientific Oy | JWY | Class II | |
| K241837 | Limbus Contour | Limbus AI | QKB | Class II | |
| K241485 | TruAbutment DS; TruBase | TruAbutment Inc. | NHA | Class II |