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 |
|---|---|---|---|---|---|
| K231411 | INNO SLA Submerged Hybrid Ti-Base System | Cowellmedi Co., Ltd. | NHA | Class II | |
| K231402 | HP PTA Balloon Dilatation Catheter | Kossel MedTech (Suzhou) Co., Ltd. | LIT | Class II | |
| K231354 | Pocket Ultrasound System (C10) | Beijing Konted Medical Technology Co., Ltd | IYN | Class II | |
| K231227 | SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath | Baylis Medical Co., Inc. | DYB | Class II | |
| K230955 | syngo Application Software | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K230855 | BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes | Becton Dickinson & Co | JKA | Class II | |
| K230850 | United Orthopedic Knee Patient Specific Instrumentation | Enhatch, Inc | OOG | Class II | |
| K230736 | MagnetOs Putty | Kuros Biosciences BV | MQV | Class II | |
| K230545 | Inessa System | Triple Jump Israel, Ltd. | QFG | Class II | |
| K223585 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear | Yung Sheng Optical Co., Ltd. | LPL | Class II | |
| K233551 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | DSY | Class II | |
| K233470 | Deka Lily | El.En S.p.A. | NGX | Class II | |
| K233448 | Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set | Integra LifeSciences Production Corporation | JXG | Class II | |
| K233163 | ZENEX Implant System_Short | Izenimplant Co., Ltd. | DZE | Class II | |
| K233132 | PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) | PRIMUS Sterilizer Company LLC | FLE | Class II | |
| K232560 | Angled Abutment | ARUM DENTISTRY Co., Ltd. | NHA | Class II | |
| K232458 | JETi™Hydrodynamic Thrombectomy System | Abbott Medical | QEZ | Class II | |
| K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | |
| K231526 | CORAIL Cemented Femoral Stem | Depuy Ireland UC | KWY | Class II | |
| K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | Providence Medical Technology, Inc. | MRW | Unclassified | |
| K222810 | TD-7301 Peak Flow meter | Gostar Co., Ltd. | BZH | Class II | |
| K221199 | Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) | Green Island International TCM Group Limited | GXY | Class II | |
| K233815 | ClotTriever Sheath | Inari Medical, Inc. | QEW | Class II | |
| K232984 | Ion Endoluminal System (IF1000) | Intuitive Surgical, Inc. | EOQ | Class II | |
| K232847 | SiOxD Wound Matrix | SiOxMed, LLC | QSZ | Unclassified | |
| K232780 | CC-Clip® Implant System | Cc-Instruments, Inc. | HTN | Class II | |
| K231929 | iQ-solutions | Sydney Neuroimaging Analysis Centre Pty Ltd | QIH | Class II | |
| K231587 | MAGNETOM Cima.X | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K231429 | S-Plant Dental Implant System | Idis Co., Ltd. | DZE | Class II | |
| K231066 | CuratOR EX3242-FD | Eizo Corporation | GCJ | Class II | |
| K222881 | Access hsTnI | Siemens Healthcare Diagnostics Inc. | MMI | Class II | |
| K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Applied Medical Technology Inc | KNT | Class II | |
| K233691 | FlexCath Cross Transseptal Solution | Acutus Medical, Inc. | DYB | Class II | |
| K233536 | Air Compression Recovery System | Shenzhen Dongjilian Medical Tech Co., Ltd | IRP | Class II | |
| K233682 | VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE | STERIS Corporation | OVY | Class II | |
| K233681 | ConFirm 20 Minute Incubator | STERIS Corporation | FRC | Class II | |
| K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000) | Eximo Medical Ltd | MCW | Class II | |
| K233607 | MagnetOs Easypack Putty | Kuros Biosciences BV | MQV | Class II | |
| K233564 | FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) | Fluoptics SAS (A Getinge Group Company) | QDG | Class II | |
| K233237 | xeo+ Family | Cutera Inc | GEX | Class II | |
| K233182 | Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) | Zibo Kaiyue Mould Technology Co., Ltd | LZA | Class I | |
| K232957 | Sterile and Non-Sterile Ultrasound Gels | Jianerkang Medical Co., Ltd. | MUI | Class II | |
| K232939 | IPL Hair Removal Device | Shenzhen Borria Technology Co.,Ltd | OHT | Class II | |
| K232892 | Hp Detect™ Stool Antigen ELISA | Biomerica | LYR | Class I | |
| K232887 | Invisalign Palatal Expander System | Align Technology, Inc. | NXC | Class II | |
| K232598 | Unscented Menstrual Tampon | Unibeauty (Hubei) Technology Co., Ltd. | HEB | Class II | |
| K232394 | Internal Locking Plate and Screw Fixation System | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd | HRS | Class II | |
| K232384 | Videa Dental Assist | VideaHealth, Inc. | MYN | Class II | |
| K232267 | Precice Max System | Nuvasive Specialized Orthopedics, Incorporated | HSB | Class II | |
| K232130 | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter | Surgical Instrument Services and Savings, Inc. | OWQ | Class II |