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 |
|---|---|---|---|---|---|
| K251192 | Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8) | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems LLC | DQY | Class II | |
| K243692 | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.r.l. | EKX | Class I | |
| K243685 | MammoScreen BD | Therapixel | QIH | Class II | |
| K243660 | Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoject™ 6mL Syringe, Luer-Lock Tip (1180600777); Monoject™ 12mL Syringe, Luer-Lock Tip (1181200777); Monoject™ 20mL Syringe, Luer-Lock Tip (1182000777); Monoject™ 35mL Syringe, Luer-Lock Tip (1183500777); Monoject™ 60mL Syringe, Luer-Lock Tip (1186000777); Monoject™ 3mL Syringe, Luer-Lock Tip (8881513934); Monoject™ 6mL Syringe , Luer-Lock Tip (8881516937); Monojec | Cardinalhealth | FMF | Class II | |
| K252356 | The Acumed Wrist Fixation System - 2.4mm Screws | Acumed LLC | HRS | Class II | |
| K252244 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid | Ever Global (Vietnam) Enterprise Corporation | LZA | Class I | |
| K251647 | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System | Dentsply Sirona Inc | DZE | Class II | |
| K251588 | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) | Shenzhen Fittop Health Technology Co., Ltd. | OHS | Class II | |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | bioMerieux, Inc. | LON | Class II | |
| K251135 | Treace Medical Concepts (TMC) Implant Fixation System | Treace Medical Concepts, Inc. | HRS | Class II | |
| K251130 | Portable Oxygen Concentrator (JM-P50A) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd | CAW | Class II | |
| K251029 | Vista OS, Vista AI Scan, RTHawk | Vista AI Inc. | LNH | Class II | |
| K250994 | ClearTip FNA and FNB Types | Finemedix | FCG | Class II | |
| K250923 | Fine Osteotomy™ | Bodycad Laboratories, Inc. | HRS | Class II | |
| K250784 | Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) | Shenzhen Yicai Health Technology Co., Ltd | NUH | Class II | |
| K243965 | Origin™ | Nerv Technology Inc. (D.B.A.) Fluidai Medical | SFO | Class II | |
| K241152 | InSee | Tidal Medical Technologies, LLC | BWF | Class II | |
| K252104 | T1d1 | Comerge AG | NDC | Class II | |
| K252061 | Distal Xtremities System | Trimed Inc | HRS | Class II | |
| K251837 | Salix Coronary Plaque (V1.0.0) | Artrya | QIH | Class II | |
| K251590 | Methinks CTA Stroke | Methinks Software, S.L | QAS | Class II | |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | Liofilchem S.r.l. | JWY | Class II | |
| K251563 | WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test | Wondfo USA Co., Ltd. | SCA | Class II | |
| K251481 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K251471 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | NHA | Class II | |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | Stryker Corp. | HSB | Class II | |
| K251229 | EndoFix™Tissue Fixation System | Softac Medical Technologies | FGE | Class II | |
| K250721 | LOCATOR® Angled Abutment | Zest Anchors LLC | NHA | Class II | |
| K250417 | Remanufactured EndoWrist Cobra Grasper (420190) | Rebotix | QSM | Class II | |
| K250383 | Wearable Breast Pump (Model W6) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) | Siemens Healthcare Diagnostics Inc. | LTT | Class II | |
| DEN250002 | Delphi-MD System | Quantalx Neuroscience | SFN | Class II | |
| K252316 | Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) | Venclose, Inc. | GEI | Class II | |
| K252022 | OSSIOfiber® Interference Screw | OSSIO, Ltd. | MAI | Class II | |
| K250539 | Remanufactured EndoWrist Tenaculum Forceps (420207) | Rebotix | QSM | Class II | |
| K250399 | Remanufactured EndoWrist Cadiere Forceps (420049) | Rebotix | QSM | Class II | |
| K250387 | Remanufactured EndoWrist Long Tip Forceps (420048) | Rebotix | QSM | Class II | |
| K250313 | Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid | Harps Europe Manufacturing | KGO | Class I | |
| K243713 | Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) | Agnes Medical Co.,Ltd | GEI | Class II | |
| K251161 | ANTHEM® Fracture System | Globus Medical, Inc. | HRS | Class II | |
| K251086 | PnueAira (PNCU-01) | Biotab LLC | JOW | Class II | |
| K250271 | Neodent Implant System - Zirconia Implant System | JJGC Industria e Comercio de Materiais Dentarios SA | DZE | Class II | |
| K250167 | Evolution Spine Navigation Instruments | Evolution Spine, LLC | OLO | Class II | |
| K243604 | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid | O&M Halyard, Inc. | LZA | Class I | |
| K243539 | Apollo TMS Therapy System | Mag & More GmbH | OBP | Class II | |
| K251913 | OsteoCentric® UnifiMI® TCS Plating System | OsteoCentric Technologies,Inc | HRS | Class II | |
| K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup | Assure Tech LLC | NFT | Class II | |
| K252236 | CP Relief Wand Rx - TENS/NMES | N & C Holdings, LLC | GZJ | Class II | |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180) | Healgen Scientific LLC | DJG | Class II |