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 |
|---|---|---|---|---|---|
| K193629 | Disposable NIBP Cuff | Shenzhen Changke Connect Electronics Co., Ltd. | DXQ | Class II | |
| K193619 | Cry-Ac®, Cry-Ac-3®, Cry-Baby | Brymill Cryogenic Systems | GEH | Class II | |
| K193615 | NorthStar™ OCT Spinal System | SeaSpine Orthopedics Corporation | NKG | Class II | |
| K193614 | FINE Osteotomy around the knee | Bodycad Laboratories, Inc. | HRS | Class II | |
| K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | OVD | Class II | |
| K193328 | IPL + Diode Laser Machine | Beijing Globalipl Development Co., Ltd. | ONF | Class II | |
| K193311 | Aluna | Knox Medical Diagnostics | BZH | Class II | |
| K193078 | MIS CONNECT Conical Connection System | Dentsply Sirona Inc | NHA | Class II | |
| K192967 | Medacta Shoulder System | Medacta International SA | PHX | Class II | |
| K192854 | MammoScreen | Therapixel | QDQ | Class II | |
| K192534 | CrossBay Endometrial Tissue Sampler (ETS) | Crossbay Medical | HHK | Class II | |
| K192437 | Arterys MICA | Arterys Inc. | QIH | Class II | |
| K192284 | DiaFil Flow | Diadent Group International | EBF | Class II | |
| K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | Ethicon, Inc | NEW | Class II | |
| K192008 | LaserShot M, NaviLase | Vitrolife Inc. | MRX | Class II | |
| K200337 | FloPatch (FP120) | Flosonics Medical (R/A 1929803 ONTARIO Corp.) | DPW | Class II | |
| K200224 | SEA-LINK Anterior Cervical Plate System | Indius Medical Technologies Pvt. Ltd. | KWQ | Class II | |
| K200209 | Persona Personalized Knee System | Zimmer GmbH | JWH | Class II | |
| K193579 | PlasmaBlade X 3.0S LIGHT | Medtronic Navigation, Inc | GEI | Class II | |
| K193335 | Sherlock | Open Implants | NHA | Class II | |
| K193145 | Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch | Megadyne Medical Products, Inc | GEI | Class II | |
| K193100 | RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System | Orthopediatrics Corp | NKB | Class II | |
| K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | Nexxt Spine LLC | OVE | Class II | |
| K200485 | RadiForce RX1270, RadiForce RX1270-AR | Eizo Corporation | PGY | Class II | |
| K200436 | Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit | Hologic, Inc. | QEP | Class II | |
| K200043 | Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range | Field Orthopaedics | HRS | Class II | |
| K193479 | Sternal Cable System | A & E Medical Corporation | JDQ | Class II | |
| K193453 | TruDi Probe | Acclarent Inc | PGW | Class II | |
| K191909 | HepaShield Bacterial Viral Breathing System Filter | Flexicare Medical Ltd. | CAH | Class II | |
| K191788 | CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA Inc | MAX | Class II | |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC | CooperVision, Inc. | LPL | Class II | |
| K191716 | Somryst | Pear Therapeutics, Inc. | QVO | Class II | |
| K200493 | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover | Stryker Corp. | FXY | Class II | |
| K200474 | Symbia 6.7 | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K200180 | MTS Omadacycline 0.002 - 32 ug/mL | Liofilchem S.r.l. | JWY | Class II | |
| K200036 | AI-ECG Tracker | Shenzhen Carewell Electronics Co., Ltd. | DPS | Class II | |
| K193659 | iTero Element 5D | Align Technology, Inc. | NTK | Class II | |
| K193609 | Q Switched Nd: YAG Laser machine | Beijing Lead Beauty S & T Co., Ltd. | GEX | Class II | |
| K193581 | Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster | SRI Trang Gloves (Thailand) Public Company Limited. | LZA | Class I | |
| K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner | Materialise N.V. | QHE | Class II | |
| K193366 | T2 Icf | Stryker Corp. | HWC | Class II | |
| K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve | Cardinal Health200, LLC | FYA | Class II | |
| K193281 | Hepatic VCAR | GE Medical Systems SCS | JAK | Class II | |
| K193211 | Nano FortiFix® System | Nanovis Spine, LLC | NKB | Class II | |
| K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter | Acist Medical Systems, Inc. | OBJ | Class II | |
| K193121 | GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims | Eco Medi Glove Sdn Bhd | LZA | Class I | |
| K193089 | MULTIX Impact | Siemens Medical Solutions USA, Inc. | KPR | Class II | |
| K192897 | icotec Cervical Cage | Icotec AG | ODP | Class II | |
| K192510 | DIAFIL & DIAFIL Capsule | Diadent Group International | EBF | Class II | |
| K192300 | EnlightenVue Microendoscopy System | Enlightenvue, Inc. | GCJ | Class II |