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 |
|---|---|---|---|---|---|
| K203454 | Infrared Thermometer | Shandong Zhushi Pharmaceutical Group Co., Ltd | FLL | Class II | |
| K202987 | Rescue Pulmonary Grasping Forceps | Anrei Medical (HangZhou) CO., Ltd. | EOQ | Class II | |
| K202619 | KardiFlex PTCA Balloon Dilatation Catheter | Medcaptain Life Science Co., Ltd. | LOX | Class II | |
| K202457 | M1 Surgical Face Mask | CHISON Medical Technologies Co., Ltd. | FXX | Class II | |
| K201024 | Expandable Titanium PLIF/TLIF System | Spectrum Spine Inc | MAX | Class II | |
| K210985 | 1717Fcc | Rayence Co., Ltd. | MQB | Class II | |
| K210982 | AMX Navigate | GE Healthcare | IZL | Class II | |
| K210925 | Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber | Boston Scientific Corporation | GEX | Class II | |
| K210621 | Oral/Enteral Syringe | Ningbo Tianyi Medical Appliance CO., Ltd. | PNR | Class II | |
| K210601 | Plato 17 Microcatheter | Scientia Vascular | DQY | Class II | |
| K210278 | Titan SGS | Standard Bariatrics | GDW | Class II | |
| K210242 | Astroglide X Silicone Personal Lubricant | Biofilm, Inc. | NUC | Class II | |
| K210020 | Medical Mask | Zhende Medical Co., Ltd. | FXX | Class II | |
| K203535 | Trinias | Shimadzu Corporation Medical Systems | OWB | Class II | |
| K203532 | BI-MENTUM™ ALTRX® Dual Mobility Liner | Depuy Ireland UC | LZO | Class II | |
| K203451 | TCL3 Motion Tracking System | TracInnovations A/S | LNH | Class II | |
| K203436 | Disposable Nitrile Examination Gloves | Shandong Zhushi Pharmaceutical Group Co., Ltd | LZA | Class I | |
| K203277 | Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps | Olympus Winter & Ibe GmbH | GEI | Class II | |
| K202757 | CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor | Contec Medical Systems Co., Ltd. | DXN | Class II | |
| K200391 | MPACT Extension | Medacta International SA | LPH | Class II | |
| K211072 | Safety Trocar Cannula | Boston Scientific Corporation | KNT | Class II | |
| K210964 | Resonic Rapid Acoustic Pulse Device | Soliton, Inc. | GEX | Class II | |
| K210660 | Stone Retrieval Balloon Catheter | Anrei Medical (HangZhou) CO., Ltd. | GCA | Class II | |
| K210609 | AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens | Vp Optics | LPL | Class II | |
| K203240 | AccelX Abutments | Integrated Dental Systems, LLC | NHA | Class II | |
| K203121 | Responsive Arthroscopy Thunderbolt System | Responsive Arthroscopy | MBI | Class II | |
| K203098 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | OAN | Class II | |
| K191951 | Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device | Avazzia, Inc | NFO | Class II | |
| K211010 | Illusion Aligners | Laxmi Dental Exports Pvt, Ltd. | NXC | Class II | |
| K210918 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | Intuitive Surgical, Inc. | NAY | Class II | |
| K210663 | Dermatological Diode Laser Systems | Beijing Huacheng Taike Technology Co., Ltd. | GEX | Class II | |
| K210347 | VSP System | 3D Systems, Inc. | DZJ | Class II | |
| K203512 | Powder Free Blue Nitrile Examination Glove | Vip Glove Sdn Bhd | LZA | Class I | |
| K203264 | MicroDose Injector | Medone Surgical, Inc. | FMF | Class II | |
| K202647 | Surgical Mask | Ningbo Green Textile Co., Ltd. | FXX | Class II | |
| K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | DRT | Class II | |
| K202258 | ERISE Laser handpiece | El.en. Electronic Engineering SpA | GEX | Class II | |
| K200260 | Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System | Boston Scientific Corporation | FAD | Class II | |
| K193070 | VIVACE Electrosurgical Device | ShenB Co., Ltd. | GEI | Class II | |
| K211190 | 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) | 3M Company, Unitek Orthodontic Products | NXC | Class II | |
| K210996 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing | Imperative Care Inc. | NRY | Class II | |
| K210890 | GPS Cervical Spacers | G Surgical Co., Ltd. | ODP | Class II | |
| K210885 | Dayspring | Koya Medical, Inc. | JOW | Class II | |
| K210626 | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter | Cordis US Corp. | LIT | Class II | |
| K210345 | 2MP Monochrome LCD Monitor MS-S200 | JVCKENWOOD Corporation | PGY | Class II | |
| K210312 | PlutoX Digital Intraoral X-Ray Imaging System | Iray Technology Taicang, Ltd. | MUH | Class II | |
| K210030 | Medical Surgical Mask | Tianjin Aoshang Outdoor Equipment Co., Ltd. | FXX | Class II | |
| K210007 | Face Mask | Jinhua Jingdi Medical Supplies Co.,Ltd | FXX | Class II | |
| K203854 | Pulse Oximeter | Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd | DQA | Class II | |
| K203835 | MIS Solution | Next Science, LLC | FRO | Unclassified |