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 |
|---|---|---|---|---|---|
| K170300 | Restrata Wound Matrix | Acera Surgical, Inc. C/O Linda Braddon, PhD | QSZ | Unclassified | |
| K170069 | AmCAD-UV | Amcad Biomed Corporation | LLZ | Class II | |
| K163332 | Apex Revision Knee System | Omni Life Science, Inc. | JWH | Class II | |
| K163149 | VisualEyes | Interacoustics a/S | GWN | Class II | |
| K162732 | Exactech® Alteon® HA Femoral Stem | Exactech, Inc. | MEH | Class II | |
| K162271 | Pro-Lock CT Safety Infusion Set | Medcomp ( Medical Components) | PTI | Class II | |
| K170936 | Cutera enlighten III Laser System | Cutera Inc | GEX | Class II | |
| K170511 | NeoFuse HA Enhanced PLIF/TLIF | Ht Medical, LLC | MAX | Class II | |
| K170260 | BC-001+ Acne Purifier | Oriental Inspiration Limited | OLP | Class II | |
| K170132 | MyoCycle Home, MyoCycle Pro | Myolyn Inc. | GZI | Class II | |
| K163675 | Processor VP-7000, Light Source BL-7000 | FUJIFILM Healthcare Americas Corporation | FET | Class II | |
| K163507 | Triton Sponge System | Gauss Surgical, Inc. | PBZ | Class II | |
| K162799 | Cliniview | Palodex Group Oy | LLZ | Class II | |
| K162661 | SavDenTM MTA Root Canal Filling Materials | Tyds Biotech Incorporation | KIF | Class II | |
| K162237 | XO1 Knee Balancing System | Xpandortho, Inc. | ONN | Class II | |
| K160670 | ET US SS Prosthetic system | OSSTEM Implant Co., Ltd. | NHA | Class II | |
| K170887 | EVOS Small Fragment Plating System | Smith & Nephew, Inc. | HRS | Class II | |
| K170858 | Fdr Aqro (Dr-Xd 1000) | FUJIFILM Healthcare Americas Corporation | IZL | Class II | |
| K170536 | ECG Disposable Lead Wire | Apk Technology Co., Ltd | DSA | Class II | |
| K170012 | Foot and Hand Motion | Newclip Technics | HWC | Class II | |
| K163650 | ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension | Wrightmedicaltechnologyinc | HRS | Class II | |
| K162748 | MindMotionPRO | Mindmaze SA | LXJ | Class II | |
| K162441 | PowerPICC Provena Catheters with SOLO Valve Technology | C.R. Bard Inc | LJS | Class II | |
| K162154 | Pantheon Medical Balanced Plating System | Pantheon Medical | HRS | Class II | |
| K162104 | C-Flex Ureteral Stent Set | Cook Incorporated | FAD | Class II | |
| K162067 | VX130 Ophthalmic Diagnostic Device | Luneau SAS | HKX | Class II | |
| K160499 | Apnea Risk Evaluation System (ARES), Model 620 | WATERMARK MEDICAL Inc | MNR | Class II | |
| DEN160030 | Oculeve Intranasal Tear Neurostimulator Device | Oculeve, Inc. | PQJ | Class II | |
| K170953 | Tomcat Cervical Spinal System | Choicespine, LP | OVE | Class II | |
| K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated | Medtronic, Inc. | GEI | Class II | |
| K170865 | EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories | Intuitive Surgical, Inc. | NAY | Class II | |
| K170721 | Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil | Precision Surgical, LLC | GEI | Class II | |
| K170716 | PercuNav Image Fusion and Interventional Navigation | Philips North America LLC | JAK | Class II | |
| K170537 | Nexxis OR, Nexxis | Barco N.V. | DXJ | Class II | |
| K170358 | joimax Endovapor 2 | Joimax GmbH | GEI | Class II | |
| K170221 | syngo.CT Cardiac Planning | Siemens Healthcare GmbH | JAK | Class II | |
| K163645 | DERMABOND PRINEO Skin Closure System | Ethicon, Inc | OMD | Class II | |
| K163537 | Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga | Medtronic, Inc. | EOQ | Class II | |
| K163516 | Braun No Touch + Forehead NTF3000 Thermometer | Kaz USA, Inc., A Helen of Troy Company | FLL | Class II | |
| K163255 | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor | Caretaker Medical | DXN | Class II | |
| K163088 | TSIII BA Fixture | OSSTEM Implant Co., Ltd. | DZE | Class II | |
| K162930 | Aero Chrome* Select Breathable Performance Surgical Gowns | Halyard Health | FYA | Class II | |
| K162655 | StealthConnect Remote Viewing, Planning and Collaboration System | Medtronic Navigation, Inc | HAW | Class II | |
| K162294 | Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Purple] Tested for Use with Chemotherapy Drugs | Brightway Holdings Sdn. Bhd. | LZA | Class I | |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP) | Randox Laboratories, Limited | CJE | Class II | |
| K162063 | Steri-Cassette and Steri-Cage Sterilization Packaging System | Sybron Dental Specialties, Inc. | KCT | Class II | |
| K160179 | VivaChek Ino Blood Glucose Monitoring System | Vivachek Laboratories, Inc. | NBW | Class II | |
| K163708 | QiF Blood and Fluid Warmer | Quality in Flow Ltd. | LGZ | Class II | |
| K163690 | DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K163677 | Ortho System | 3Shape A/S | PNN | Class II |