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 |
|---|---|---|---|---|---|
| K212839 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt. Ltd. | JWH | Class II | |
| K212455 | InZone Detachment System | Stryker Corp. | HCG | Class II | |
| K212344 | Surgical Mask | Xiantao Dingcheng Non-Woven Product Co., Ltd. | FXX | Class II | |
| K212265 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K212047 | Pantheris System | Avinger, Inc. | MCW | Class II | |
| K212029 | Disposable Medical Nitrile Examination Gloves (non-sterile) | Taizhou Kangjian Medical Equipments Co., Ltd. | LZA | Class I | |
| K211845 | Deploy Expandable Interbody System | Southern Spine, LLC | MAX | Class II | |
| K211697 | Esperance Aspiration Catheter System | Wallaby Medical | NRY | Class II | |
| K211286 | Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger | Pall Corporation | CAH | Class II | |
| K210854 | Enteral Feeding Set | KB Medical (Group) Inc. | PIF | Class II | |
| DEN210014 | EaseVRx | Appliedvr | QRA | Class II | |
| K213497 | ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) | H&abyz | MQB | Class II | |
| K213449 | DS Implants abutments provided with the EV connection | Dentsply Sirona Inc | NHA | Class II | |
| K213436 | Clarius Ultrasound Scanner | Clarius Mobile Health Corp | IYN | Class II | |
| K213254 | Axialis Ophthalmic Ultrasound System | Quantel Medical | IYO | Class II | |
| K213000 | Air Compression Massager (Model LF-FT003) | Wenzhou Lingfeng Electronic Technology Co., Ltd | IRP | Class II | |
| K212765 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (Hunan) Co.,Ltd. | EIH | Class II | |
| K212731 | Circul8 Pro | Precision Medical Products | JOW | Class II | |
| K212695 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy-America, Inc. | OWN | Class II | |
| K212607 | Darwin | Luvo Medical Technologies, Inc. | GEX | Class II | |
| K212301 | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device | Medtronic, Inc. | LFL | Unclassified | |
| K211754 | Vital Signs Monitor | Beijing Choice Electronic Technology Co., Ltd. | MWI | Class II | |
| K211483 | SofWave System | Sofwave Medical Ltd. | OHV | Class II | |
| K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle | Jiangsu Kangbao Medical Equipment Co., Ltd | MEG | Class II | |
| K212575 | Surgical Face Mask | Hubei Huanfu Plastic Products Co., Ltd | FXX | Class II | |
| K212109 | Spin Care Disposable Protective Mask Level 3 | Spintech, Inc. | FXX | Class II | |
| K212264 | Surgical Face mask | Nantong Taiweishi Medical Technology Co., Ltd. | FXX | Class II | |
| K210785 | Disposable Surgical Gowns | Chongqing Litai Fashion Group Limited Company | FYC | Class II | |
| DEN210006 | Hemolung Respiratory Assist System | Alung Technologies, Inc. | QOH | Class II | |
| K212984 | MiPACS HTML5 Web Viewer | Lead Technologies, Inc. | LLZ | Class II | |
| K212621 | MAMMOVISTA B.smart | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K212595 | Erchonia FX-405 | Erchonia Corporation | NHN | Class II | |
| K212448 | NightGuard Flex | Sprintray Inc. | MQC | Unclassified | |
| K212259 | Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Zirdent New Material Co.,Ltd | EIH | Class II | |
| K211876 | Intellijoint VIEW | Intellijoint Surgical Inc. | LLZ | Class II | |
| K211359 | Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation | TORNIER Inc. | PHX | Class II | |
| K210989 | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System | Brainlab, Inc. | HAW | Class II | |
| K210757 | ETEST Fosfomycin (FO) (0.032-512 µg/mL) | bioMerieux, Inc. | JWY | Class II | |
| K210383 | Wrap Accessory Electrodes | Hi-Dow International Inc. | GXY | Class II | |
| K203184 | HYDRASHIFT 2/4 isatuximab | Sebia, Inc. | CFF | Class II | |
| K202671 | DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) | Guangzhou Xinbo Electronic Co., Ltd | NUH | Class II | |
| K202319 | Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) | Tianjin Huahong Technology Co., Ltd. | FMI | Class II | |
| K213364 | EnSite X EP System | Abbott Medical | DQK | Class II | |
| K212532 | Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) | Crdlight Optoelectronic Technology Co., Ltd. | LZA | Class I | |
| K212497 | Nitrile Examination Glove (Powder free, Blue) | Jiangsu Jinlian Medical Technology Co., Ltd. | LZA | Class I | |
| K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System | ConforMIS, Inc. | JWH | Class II | |
| K213089 | Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector | Fresenius Kabi USA, LLC | FPA | Class II | |
| K212978 | Diode laser therapy system | Beijing Unt Technology Co.,Ltd | GEX | Class II | |
| K212887 | RTapp | Segana, Inc. | LLZ | Class II | |
| K212659 | More-Cell-System | Agency for Medical Innovations Inc. | PMU | Class II |