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 |
|---|---|---|---|---|---|
| K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | Medtronic Xomed, Inc. | ETN | Class II | |
| K213473 | Antimicrobial Gelling Fiber Dressing with PHMB | Advanced Medical Solutions Limited | FRO | Unclassified | |
| K233210 | sam CS Long Duration Ultrasound Device | ZetrOZ Systems | PFW | Class II | |
| K233147 | PiXel8-RF | Rohrer Aesthetics, Inc. | GEI | Class II | |
| K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) | Starmed Co.,Ltd | KNS | Class II | |
| K233093 | Balanced Knee® System TriMax PS Plus Tibial Insert | Ortho Development Corp. | JWH | Class II | |
| K232436 | Rapid SDH | Ischemaview, Inc. | QAS | Class II | |
| K232235 | Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro | Magstim Inc. | OBP | Class II | |
| K231995 | AcuityUDR | RadmediX, LLC | KPR | Class II | |
| K231327 | POWERSEAL Sealer and Divider | Gyrus ACMI, Inc. | GEI | Class II | |
| K231069 | PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA | NKB | Class II | |
| K230842 | SignalHF (IM008) | Implicity | QNL | Class II | |
| K230645 | BeneHold™ Surgical Incise Drape with CHG antimicrobial II | Avery Dennison Medical Ltd. | KKX | Class II | |
| K230511 | K3900 Ultrasound Imaging System | Maui Imaging | IYO | Class II | |
| K230284 | Penumbra LP Coil System | Penumbra Inc. | HCG | Class II | |
| K222997 | VVR Generator system | Starmed Co.,Ltd | GEI | Class II | |
| K221615 | Newclip Patient-matched instrumentation non sterile PSI | Newclip Technics | PBF | Class II | |
| K221315 | UNIdental Symphony Implant System | Unidental Co., Ltd. | DZE | Class II | |
| K233348 | 16 Breast Coil | Philips Medical System Nederlands B.V. | MOS | Class II | |
| K233185 | MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System | C2Dx, Inc. | GEI | Class II | |
| K232683 | Knotilus+ PEEK Knotless Anchor | Stryker Corp. | MBI | Class II | |
| K232638 | FilteredFlo Warming Blankets | Iob Medical, Inc. | DWJ | Class II | |
| K232586 | Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System | K&J Consulting Corp. | NKB | Class II | |
| K232584 | Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter | Vein 360, LLC | OWQ | Class II | |
| K232570 | Steerant™ Super Stiff Guidewire | Medtronic, Inc. | DQX | Class II | |
| K232356 | Laser Cap, Model: Hat-01 | Hubei Yjt Technology Co.,Ltd | OAP | Class II | |
| K232223 | PlaDuo System | ShenB Co., Ltd. | GEI | Class II | |
| K232211 | REUNION Sacroiliac Joint Fusion System | Astura Medical | OUR | Class II | |
| K232086 | spineEOS | EOS imaging | LLZ | Class II | |
| K232051 | VISULAS green | Carl Zeiss Meditec Inc | HQF | Class II | |
| K231509 | Aco Apache Ultrasound System | Aco Healthcare Co., Ltd. | IYN | Class II | |
| K230919 | Acumen IQ finger cuff | Edwards Lifesciences LLC | DXN | Class II | |
| K230472 | Sonopuls 190 | Enraf-Nonius B.V. | IMI | Class II | |
| K233258 | Shadow Knotless All-Suture Anchors | Responsive Arthroscopy | MBI | Class II | |
| K232561 | Ripley Spinal Screw System by SAGICO | Sagico VA USA, LLC | NKB | Class II | |
| K232305 | AI-Rad Companion Brain MR | Siemens Medical Solutions USA, Inc. | QIH | Class II | |
| K232205 | Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set | Vesco Medical LLC | LZH | Class II | |
| K232201 | VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin | bioMerieux, Inc. | LON | Class II | |
| K232143 | Applanation Tonometer HT-5000 | Huvitz Co., Ltd. | HKY | Class II | |
| K231764 | Ultrasound System 1300 | BK Medical ApS | IYN | Class II | |
| K231732 | CleanSeal Advanced Bipolar Vessel Sealer Maryland | ConMed Corporation | GEI | Class II | |
| K231560 | MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K230893 | Swiss LthoClast Trilogy | E.M.S. - Electro Medical Systems SA | FEO | Class II | |
| K230281 | Picoclamp | Kono Seisakusho | DXC | Class II | |
| K232091 | JO Coconut Hybrid Cooling Personal Lubricant | CC Wellness LLC | NUC | Class II | |
| K231539 | pRESET LITE Thrombectomy Device | Phenox Inc | POL | Class II | |
| K233065 | V-PRO maX 2 Low Temperature Sterilization System | STERIS Corporation | MLR | Class II | |
| K232951 | BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) | STERIS Corporation | ODC | Class II | |
| K232922 | Pure-Vu EVS System | MOTUS GI Medical Technologies Ltd. | FDF | Class II | |
| K232552 | TuxDeluxe (Size 1 6100B, Size 2 6101B) | Tuxedo Imaging | MUH | Class II |