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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 | Maquet Critical Care AB | BSZ | Class II | |
| K170493 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K170476 | Nio Color 5.8MP (MDNC-6121) | Barco N.V. | PGY | Class II | |
| K163565 | MR8 Drill System | Medtronic Powered Surgical Solutions | HBC | Class II | |
| K162789 | Foresight Intracardiac Echocardiology (ICE) System | Conavi Medical Inc | DQO | Class II | |
| K162405 | Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) | Comfort Rubber Gloves Industries Sdn Bhd | LZA | Class I | |
| K161816 | BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO | bioMerieux, Inc. | MDB | Class I | |
| K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | Abbott Medical | FRN | Class II | |
| K163248 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | Boston Scientific Corporation | EOQ | Class II | |
| K161812 | Freedom Syringe | Procedure Products, Inc. | FMF | Class II | |
| K161731 | Cleveland Multiport Ventricular Catheter Set | Parker Hannifin Corp. | HCA | Class II | |
| K161667 | Sapphire Infusion Pump | Q Core Medical, Ltd. | FRN | Class II | |
| DEN160028 | ipsogen JAK2 RGQ PCR Kit | Qiagen | PSU | Class II | |
| K162784 | Silk'n HST | Home Skinovations, Ltd. | OHS | Class II | |
| K170701 | GEN_2 and GEN_3 Mechanical Wheelchairs | Free Wheelchair Mission | IOR | Class I | |
| K170335 | Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens | Valley Contax, Inc | HQD | Class II | |
| K170329 | Basic, Dominant Flex | Modela AG | QPB | Class II | |
| K170204 | FFR Link, FFR Signal Processing Module | Boston Scientific Corporation | DRG | Class II | |
| K163587 | VERIFY Incubator for Assert Self Contained Biological Indicators | STERIS Corporation | OWP | Class II | |
| K163491 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | ODP | Class II | |
| K163425 | NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System | Narang Medical USA Corporation | HRS | Class II | |
| K163297 | Scan&GO | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K163290 | INFINITT ULite | Infinitt Co., Ltd. | LLZ | Class II | |
| K163267 | Nitrile Examination Glove | Brightway Holdings Sdn. Bhd. | LZA | Class I | |
| K163249 | GoSpiro | Monitored Therapeutics, Inc. | BZG | Class II | |
| K162979 | Veloxion System | Corinth Medtech, Inc. | FJL | Class II | |
| K162967 | nuance UNIVERSAL | Den-Mat Holdings, LLC | EBF | Class II | |
| K162850 | GuideMia Ortho+ | Guidemia Technologies, LLC | PNN | Class II | |
| K162701 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | OWP | Class II | |
| K162615 | Mould Applicator Set | Varian Medical Systems, Inc. | JAQ | Class II | |
| K162556 | Lightfusion LED System | Vitage Led, Ltd. | GEX | Class II | |
| K162503 | Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software | Cardiac Insight, Inc. | DSH | Class II | |
| K162342 | Stellaris Elite Vision Enhancement System | Bausch+Lomb | HQC | Class II | |
| K162235 | Luvena Vaginal Moisturizer & Lubricant | Laclede, Inc. | NUC | Class II | |
| K162028 | PREMIUM - SHELTA Prosthetic Components | Sweden & Martina Inc | NHA | Class II | |
| K162023 | CardioDay V2.5 | Getemed Medizin- und Informationstechnik AG | DQK | Class II | |
| K161835 | iovera system | Myoscience, Inc. | GXH | Class II | |
| K161680 | MEDICON Spinal Spreading Systems | Medicon, E.G. | GZT | Class II | |
| K160581 | K3PRO Konus Additional Abutments and Implants | Argon Med. Productions Vertriebs Gesellschaft mbH CO KG | DZE | Class II | |
| K170277 | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K163558 | Synapsys Ulmer Video Nystagmograph | Synapsys, Inc. | GWN | Class II | |
| K163314 | Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter | Boston Scientific Corporation | DQY | Class II | |
| K163182 | Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories | Medtronic Powered Surgical Solutions | HBB | Class II | |
| K163103 | Tranberg CLS Diffusor Laser Fiber | Clinical Laserthermia Systems AB | GEX | Class II | |
| K162217 | Loyon | Sonoma Pharmaceuticals, Inc. | FRO | Unclassified | |
| K162037 | Eclipse with VEMP | Interacoustics a/S | GWJ | Class II | |
| K161428 | PerfectSmooth | Shen Zhen Cosbeauty Co., Ltd. | OHT | Class II | |
| K170636 | Fathom-16 Steerable Guidewires | Boston Scientific Corporation | DQX | Class II | |
| K170530 | Butrex Lumbar Buttress Plating System | Xtant Medical Holdings, Inc. | KWQ | Class II | |
| K170520 | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ | Alcon Laboratories | MLZ | Class II |