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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K151344 | Cytoflex Tefguard Ti-Enforced Membrane | Unicare Biomedical, Inc. | NPK | Class II | |
| K151296 | Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) | Bios S.r.l. | PBX | Class II | |
| K150985 | Medihoney Wound Gel | Derma Sciences, Inc. | FRO | Unclassified | |
| K150799 | Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula | Innovacyn, Inc. | FRO | Unclassified | |
| K150645 | AN1087 Dosimeter | Andersen Sterilizers, Inc. | JOJ | Class II | |
| K150637 | Aerin Medical Wand Model FG011 | Aerin Medical, Inc. | GEI | Class II | |
| K150455 | RT2 Trabeculite Titanium Cervical Cage System | Rhausler, Inc. | ODP | Class II | |
| K150299 | Gmate SMART Blood Glucose Monitoring System | Philosys, Inc. | NBW | Class II | |
| K150094 | Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla | Good Clean Love, Inc. | NUC | Class II | |
| K143310 | MoisturemeterD | Delfin Technologies Ltd | OBH | Class II | |
| K153022 | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nethrlands BV | LLZ | Class II | |
| K152758 | Venue 50 | GE Healthcare | IYN | Class II | |
| K152695 | 8 CH Knee SPEEDER | Quality Electrodynamics | MOS | Class II | |
| K152514 | Clickfine AutoProtect Pen Needle | Ypsomed AG | FMI | Class II | |
| K152058 | Tyvek Sterilization Pouches with Chevron Seal | Andersen Sterilizers, Inc. | FRG | Class II | |
| K151585 | Andersen EOGas 4 SteriTest | Andersen Sterilizers, Inc. | FRC | Class II | |
| K151234 | R350 guidewire | Vascular Solutions LLC | DQX | Class II | |
| K150684 | WASTON General Spinal System | Changzhou Waston Medical Appliance Co., Ltd. | MNI | Class II | |
| K150646 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | FLF | Class II | |
| K150644 | AN85/AN86 EO Indicators | Andersen Sterilizers, Inc. | JOJ | Class II | |
| K143630 | Invisalign System | Align Technology, Inc. | NXC | Class II | |
| K153031 | RANGE/DENALI/MESA Spinal System | K2m, Incorporated | NKB | Class II | |
| K152848 | Autolap System | M.S.T Medical Surgery Technologies, Ltd. | GCJ | Class II | |
| K152847 | DIVA ZSP5812CMI with QUBYX PerfectLum bundle | Qubyx Limited | PGY | Class II | |
| K152678 | TYRX Neuro Antibacterial Envelope | Tyrx, Inc. | FTL | Class II | |
| K152318 | MD-2300S Ultrasonic A/B Scanner for Ophthalmology | Meda Co., Ltd. | IYO | Class II | |
| K152041 | Renaissance X System | Mazor Robotics Ltd | OLO | Class II | |
| K152004 | Nanova Universal Composite | Nanova Biomaterials Inc | EBF | Class II | |
| K151682 | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) | Daxwell, LLC | LYZ | Class I | |
| K151004 | PULLUP® Adjustable Juxtacortical Fixation Device | Sbm Sciences for Bio Materials | MBI | Class II | |
| K153073 | UroNav (Version 2.0) | Invivo Corporation | LLZ | Class II | |
| K152740 | Radifocus Glidewire | Ashitaka Factory of Terumo Corp. | DQX | Class II | |
| K152661 | HICAT Air | Hicat GmbH | LLZ | Class II | |
| K152298 | EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base | Microport Orthopedics Inc. | MBH | Class II | |
| K152255 | BoneCam Suture Anchors | Valeris Medical | MBI | Class II | |
| K152252 | Arthrex iBalance TKA System | Arthrex GmbH | MBH | Class II | |
| K152019 | HairMD | Trophy Skin, Inc. | OAP | Class II | |
| K151825 | Viradius Neurowire | Mivi Neuroscience, Inc. | MOF | Class II | |
| K151798 | Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System | Prismatik Dentalcraft, Inc. | NHA | Class II | |
| K151607 | Finessis Zero Flexylon Powder Free Sterile White Surgical Glove | Lucenxia Prescience AG | KGO | Class I | |
| K151605 | Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves | Lucenxia Prescience AG | KGO | Class I | |
| K151504 | ICS Impulse | Natus Medical Denmark ApS | GWN | Class II | |
| K151227 | KYPHON XPEDE Bone Cement | Medtronic, Inc. | NDN | Class II | |
| K150790 | REDAPT Porous Acetabular Shell and Cemented Liner | Smith & Nephew, Inc. | LPH | Class II | |
| K150612 | Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free) | Anhui Anyu Latex Products Co., Ltd. | LYY | Class I | |
| K150609 | Annuy Latex Surgeon's Gloves (Powdered and Powder Free) | Anhui Anyu Latex Products Co., Ltd. | KGO | Class I | |
| K150504 | GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor | Pci Medical, Inc. | PSW | Class II | |
| K153075 | Klassic Knee System | Total Joint Orthopedics, Inc. | JWH | Class II | |
| K153049 | LithoVue System | Boston Scientific Corporation | FGB | Class II | |
| K152936 | Sirius Max Dental Diode Curing Light | National Dental, Inc. | EBZ | Class II |