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 |
|---|---|---|---|---|---|
| K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F | Interrad Medical Inc | KMK | Class I | |
| K191580 | BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device | Varian Medical Systems, Inc. | JAQ | Class II | |
| K191384 | RayCare 2.3 | RaySearch Laboratories AB (publ) | MUJ | Class II | |
| K190485 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | Kawasumi Laboratories Co., Ltd. | JKA | Class II | |
| K190286 | Materialise Glenoid Positioning System | Materialise N.V. | KWS | Class II | |
| K190277 | ProVate Vaginal Support | Contipi Medical Ltd | HHW | Class II | |
| K190064 | nView system 1 | Nview Medical | OWB | Class II | |
| K183153 | Microwave Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | NEY | Class II | |
| K183050 | GLISSANT Intimate Lubricant | Vjuvenate, LLC | NUC | Class II | |
| K182615 | Surgikor Dental Implant System | Surgikor, LLC | DZE | Class II | |
| K181456 | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves | Tuttnauer Ltd. | FLE | Class II | |
| K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) | C.R. Bard Inc | LJT | Class II | |
| K180365 | PRAMA White Implant Systems | Sweden & Martina Inc | DZE | Class II | |
| K191367 | Harrier-SA Lumbar Interbody System | Choice Spine LLC | MAX | Class II | |
| K191238 | Zimmer Guide Wire Devices | Zimmer GmbH | HSB | Class II | |
| K190924 | Revitive Medic Plus, Revitive Advanced 2 | Actegy Ltd. | NGX | Class II | |
| K190645 | Arthrex NanoScope System | Arthrex GmbH | GCJ | Class II | |
| K190594 | AngioVac C20, AngioVac C180 | Boston Scientific Corporation | DWF | Class II | |
| K190548 | BIOMONITOR III, Remote Assistant III | BIOTRONIK AG | MXD | Class II | |
| K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System | Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) | MAX | Class II | |
| K190456 | Btl 799-2L | BTL Industries, Inc | NGX | Class II | |
| K190324 | OrthoPediatrics Cannulated Screw System | Orthopediatrics Corp | HWC | Class II | |
| K190254 | Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask | SleepNet Corporation | BZD | Class II | |
| K190174 | Miethke Shunt System GAV 2.0 and SA 2.0 Valves | Aesculap Inc | JXG | Class II | |
| K182904 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K182901 | Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE | Canon Medical Systems Corporation | JAK | Class II | |
| K182414 | Aesculap® SterilContainer(TM) S2 System | Aesculap Inc | KCT | Class II | |
| K190950 | Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) | MEDLINE INDUSTRIES, LP - Northfield | FYA | Class II | |
| K183149 | Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim | Central Medicare Sdn Bhd | LZC | Class I | |
| K191495 | Biopsy Positioner | FUJIFILM Corporation | IZH | Class II | |
| K191468 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K191451 | CMDR 2CW (Multiple models) | Minxray Inc | IZL | Class II | |
| K191204 | Infinity Fixation System | ConMed Corporation | MBI | Class II | |
| K191169 | NuVasive® Camber Laminoplasty System | Nu Vasive, Incorporated | NQW | Class II | |
| K191018 | Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors | Medline ReNewal | NLF | Class II | |
| K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology | Medtronic Sofamor Danek USA Inc | MAX | Class II | |
| K190915 | OsteoFab Suture Anchors | Oxford Performance Materials, Inc. | MBI | Class II | |
| K190724 | MD-Temp Plus | Meta Biomed Co., Ltd. | EBG | Class II | |
| K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments | Cochlear Americas | PFO | Class II | |
| K190442 | Koios DS for Breast | Koios Medical, Inc. | POK | Class II | |
| K190272 | Bluephase PowerCure | Ivoclar Vivadent, Inc. | EBZ | Class II | |
| K183058 | Arm-type Electronic Blood Pressure Monitor | Shenzhen BSX Technology Electronics Co.,Ltd | DXN | Class II | |
| K182780 | XP Composite | S&C Polymer Silicon- und Composite Spezialitaeten | EBF | Class II | |
| K182580 | Novidia Flowable Composite | Nobio, Ltd. | EBF | Class II | |
| K180968 | AlphaDent Implants Dental Implants System | Alphadent Implants, Ltd. | DZE | Class II | |
| K191460 | PWD Platform Wound Dressing 3” x 5” Oblong | Applied Tissue Technologies, LLC | OMP | Class II | |
| K191137 | 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 | JVCKENWOOD Corporation | PGY | Class II | |
| K191008 | iLab Polaris Multi-Modality Guidance System | Boston Scientific Corporation | DQK | Class II | |
| K190687 | Twilite Appliance | Stephen J Harkins, Dds, PC | LRK | Class II | |
| K190634 | Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System | Cardiovascular Systems Incorporated | MCW | Class II |