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 |
|---|---|---|---|---|---|
| K230003 | Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Topzir Biotech Co., Ltd | EIH | Class II | |
| K223778 | Diode Laser Hair Removal System (RD-SLD600) | Shanghai Omni Laser Skinology Co., Ltd. | GEX | Class II | |
| K223570 | SonoAir Series Digital Color Doppler Ultrasound System | CHISON Medical Technologies Co., Ltd. | IYN | Class II | |
| K223017 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 | Canon Medical Systems Corporation | IYN | Class II | |
| K220780 | ROVO Mechanical Thrombectomy Device | 2mg, Inc. | QEW | Class II | |
| K220068 | Butterfly iQ/iQ+ Ultrasound System | Butterfly Network, Inc. | IYO | Class II | |
| K213660 | RadAlly | Imaging Wave, LLC | LLZ | Class II | |
| K213272 | Formus Hip | Formus Labs, Ltd. | QIH | Class II | |
| K211059 | CereFlow™ V1.2 | Translational Mri, LLC | LLZ | Class II | |
| DEN200011 | Masimo SafetyNet | Masimo Corporation | QVT | Class II | |
| K230636 | Maestro Microcatheter | Merit Medical System, Inc. | KRA | Class II | |
| K230590 | ARDO Bellis | Ardo Medical AG | HGX | Class II | |
| K230555 | Cemented Tibia Baseplate no Taper with JRNY Lock | Smith & Nephew, Inc. | JWH | Class II | |
| K230161 | ONLINE TDM Phenytoin - Free Phenytoin application | Roche Diagnostics GmbH | MOJ | Class II | |
| K223923 | HOPKINS Telescopes | Karl Storz Endoscopy-America, Inc. | GCJ | Class II | |
| K223853 | Medartis APTUS® Ulna Plates | Medartis AG | HRS | Class II | |
| K223422 | Emory Cardiac Toolbox 4.3 | Syntermed, Inc. | KPS | Class II | |
| K223377 | BIASURGE Advanced Surgical Solution | Rochal Technologies LLC | FRO | Unclassified | |
| K223342 | MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System | Crossroads Extremity Systems LLC | HRS | Class II | |
| K223326 | Axiom PSR System | restor3d, Inc. | OYK | Class II | |
| K222112 | Comfort Marker 2.0 | Medical Precision BV | QRN | Class II | |
| K221872 | ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System | Nova Eye Inc. (Business Name Nova Eye Medical) | MPA | Class II | |
| K221324 | ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) | Camber Spine Technologies | OVD | Class II | |
| K221320 | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX | Nidek Co., Ltd. | OBO | Class II | |
| K220088 | Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Professional Latex Sdn Bhd | LZA | Class I | |
| DEN210039 | SNOO Smart Sleeper | Happiest Baby, Inc | QTG | Class II | |
| K230527 | WishBone Medical Plate and Screw System | Wishbone Medical, Inc. | HRS | Class II | |
| K230243 | ROSA® Knee System | Orthosoft D/B/A Zimmer Cas | OLO | Class II | |
| K223916 | PUMA-G System | CoapTech, Inc. | KGC | Class II | |
| K223915 | Tactoset | Anika Therapeutics, Inc. | MQV | Class II | |
| K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | MAX | Class II | |
| K223305 | Trevo NXT ProVue Retriever | Stryker Corp. | POL | Class II | |
| K222871 | Stethophone v1 | Sparrow Acoustics Inc. | DQD | Class II | |
| K222485 | SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser | Ids, Limited | GEX | Class II | |
| K222397 | KLS Martin Level One Rib Fixation System | KLS-Martin L.P. | HRS | Class II | |
| K222312 | RayStation 12A | RaySearch Laboratories AB (publ) | MUJ | Class II | |
| K221984 | InterView XP; InterView FUSION | Mediso Medical Imaging Systems, Lttd. | LLZ | Class II | |
| K213815 | SiJoin®T3 | VGI medical, LLC | OUR | Class II | |
| K212423 | EndoDrill® Model X | Bibbinstruments AB | FCG | Class II | |
| DEN220030 | RemeOs™ Screw LAG Solid | Bioretec Ltd. | QJD | Class II | |
| K230582 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | MED | Class II | |
| K230271 | ISOLIS Cryoprobe | Varian Medical Systems, Inc. | GEH | Class II | |
| K230255 | Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 | Stryker Sustainability Solutions | GEI | Class II | |
| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | Stryker Sustainability Solutions | NUJ | Class II | |
| K230026 | Squale | Implanet | ODP | Class II | |
| K223928 | Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K | Shenzhen Fansizhe Science and Technology Co., Ltd. | OHT | Class II | |
| K223625 | CapnoSpot™ Pneumothorax Decompression Indicator | Pneumeric, Inc. | GAA | Class I | |
| K223343 | MAGNETOM Amira; MAGNETOM Sempra | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K222729 | Electrical Scooter, WT-T4QP2 | Wu's Tech Co., Ltd. | INI | Class II | |
| K222268 | Annalise Enterprise CXR Triage Trauma | Annalise-Ai Pty, Ltd. | QFM | Class II |