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 |
|---|---|---|---|---|---|
| K232285 | U-Lite PRO | Sonoscanner SARL | IYN | Class II | |
| K232250 | SurgiCount+ System | Stryker Corp. | PBZ | Class II | |
| K231774 | CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) | Macrolux Medical Technology Co., Ltd. | FGB | Class II | |
| K231633 | Disposable Hemoclip (AF series) | Alton Shanghai Medical Instruments Co Ltd | PKL | Class II | |
| K231088 | Copper Foam Dressing (Prescription and OTC) | Roosin Medical Co., Ltd. | FRO | Unclassified | |
| K222929 | ToxiSeal Vial Adapter with External Balloon | Epic Medical Pte., Ltd. | ONB | Class II | |
| DEN220066 | BrainSee | Darmiyan, Inc. | QWT | Class II | |
| K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | CarboFix Orthopedics Inc. | NKB | Class II | |
| K233903 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical Inc. | HAW | Class II | |
| K233902 | Centurion™ Vision System (Active Sentry™) (8065753057) | Alcon Laboratories | HQC | Class II | |
| K233364 | Axon Therapy | Neuralace Medical | QPL | Class II | |
| K232955 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort Neurotech (Shanghai) Co., Ltd. | HCG | Class II | |
| K232604 | LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) | Hangzhou Laihe Biotech Co.,Ltd. | LDJ | Class II | |
| K233327 | 1788 4K Camera System with Advanced Imaging Modality | Stryker Corp. | GCJ | Class II | |
| K232710 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | OAS | Class II | |
| K232597 | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) | Hangzhou Laihe Biotech Co.,Ltd. | DJG | Class II | |
| K232312 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | DSY | Class II | |
| K233615 | Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1 | Baisheng Medical Co.,Ltd. | GEI | Class II | |
| K233444 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc | MOS | Class II | |
| K233035 | Electronic Muscle Stimulator (Model MP01) | Shenzhen Hengbosi Industrial Co., Ltd. | NGX | Class II | |
| K232894 | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) | Owens & Minor (O&M) Halyard, Inc. | FXX | Class II | |
| K232412 | LungQ v3.0.0 | Thirona BV | JAK | Class II | |
| K232106 | Air Gap Fiber | WONTECH Co., Ltd. | GEX | Class II | |
| K231324 | DASI Dimensions (V1.0) | Dasi Simulations | QIH | Class II | |
| K232721 | Lifetech Cardio Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | DTE | Class II | |
| K231608 | Teleport XT Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | DQY | Class II | |
| K231068 | autoSCORE | Holberg EEG AS | OMB | Class II | |
| K233679 | IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K233316 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II | |
| K233229 | NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether | Anx Robotica Corp. | NEZ | Class II | |
| K232519 | ENDOCOLLECT Specimen Retrieval Bag | Ximedica | GCJ | Class II | |
| K231917 | VEA Align | EOS imaging | QIH | Class II | |
| K231273 | ArcherQA (V1.0) | Wisdom Technologies, Inc. | IYE | Class II | |
| K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT | Prevest Denpro Limited | EBF | Class II | |
| K231163 | HS Fiber Sutures | Riverpoint Medical, LLC | GAT | Class II | |
| K221766 | Solon | LMG Lasers Comercio Importacao e Exportacao Ltda | GEX | Class II | |
| K233671 | Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance | Ambu A/S | EOQ | Class II | |
| K233556 | LED Eye mask (EY-20R, A20, EY-20N) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OHS | Class II | |
| K232808 | Butterfly iQ3 Ultrasound System | Butterfly Network, Inc. | IYN | Class II | |
| K232330 | Lancing System | Ningbo Medsun Medical Co., Ltd. | QRK | Class II | |
| K232136 | syngo.CT Applications | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K231072 | Anthogyr FlexiBase® titanium bases for Axiom® BL | Anthogyr | NHA | Class II | |
| K231058 | Hudson RCI® AddiPak® Unit Dose Vial | MEDLINE INDUSTRIES, LP - Northfield | CAF | Class II | |
| K231033 | CEPTRE® Knotted UHMWPE Suture PEEK Anchor | Healthium MedTech Limited | MBI | Class II | |
| K230996 | Pursuant Health Kiosk (G1.D5) | Pursuant Health | DXN | Class II | |
| K230507 | Zimed Distal Medial Tibial Plate and Screw System | Zimed Medikal | HWC | Class II | |
| K230277 | Pulse Oximeter(Model OHT60,OXH78) | Cofoe Medical Technology Co.,Ltd | DQA | Class II | |
| K223228 | Dayspring | Koya Medical, Inc. | JOW | Class II | |
| K221110 | LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing | HuiZhou Foryou Medical Devices Co., Ltd. | FRO | Unclassified | |
| K233395 | Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) | Alliage S/A Industrias Medico Odontologica | EHD | Class II |