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 |
|---|---|---|---|---|---|
| K182274 | Orbit Subretinal Delivery System | Orbit Biomedical | FMF | Class II | |
| K182265 | CodMan Certas Plus Programmable Valve | Integra LifeSciences Corporation | JXG | Class II | |
| K182133 | Infrared Thermometer | Shenzhen AOJ Medical Technology Co., Ltd. | FLL | Class II | |
| K181857 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Kossan International Sdn Bhd | LZA | Class I | |
| K181806 | ARIX Sternal System | Jeil Medical Corporation | HRS | Class II | |
| K181731 | MR Compatible Aspiration Kit | Mri Interventions, Inc. | GWG | Class II | |
| K181247 | Vitrea CT Brain Perfusion | Canon Medical Informatics, Inc. | LLZ | Class II | |
| K180917 | GC Acrylic Primer | GC America Inc. | KLE | Class II | |
| K180550 | NuVasive Monolith Cervical Corpectomy System | Nu Vasive, Incorporated | PLR | Class II | |
| K182772 | Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil | Medtronic, Inc. | GEI | Class II | |
| K182654 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | Safecare Biotech(hangzhou)co.,Ltd | NGG | Class II | |
| K182535 | R3 Anteverted Liners | Smith & Nephew, Inc. | MBL | Class II | |
| K180432 | AI-ECG Platform | Shenzhen Carewell Electronics Co., Ltd. | DQK | Class II | |
| DEN180030 | QMS Plazomicin Immunoassay | Microgenics Corporation | QDR | Class II | |
| K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary Stent | Cook Ireland Ltd. | FGE | Class II | |
| K182958 | 1.5T 16ch Breast Coil | NeoCoil, LLC | MOS | Class II | |
| K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr | LeMaitre Vascular Inc. | MJN | Class II | |
| K182626 | OEC One | GE Hualun Medical Systems Co., Ltd. | OXO | Class II | |
| K182562 | Hair Boom 69 | WONTECH Co., Ltd. | OAP | Class II | |
| K182298 | hemochroma PLUS System | Immunostics, Inc. | GKR | Class II | |
| K182201 | Stratum™ Foot Plating System | Medartis AG | HRS | Class II | |
| K182179 | AdvantageRib Anterior System | Sig Medical Corp. | HRS | Class II | |
| K182109 | REDAPT Modular Acetabular Shell | Smith & Nephew, Inc. | LPH | Class II | |
| K182090 | AposTherapy System | APOS Medical Assets Ltd | QDT | Class I | |
| K181948 | 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil | Rapid Biomedical GmbH | MOS | Class II | |
| K181921 | Solidity Vertebral Body Replacement | ulrich medical USA Inc | MQP | Class II | |
| K181709 | Serenity Piezo Sensor, Serenity Thermocouple Sensor | Neurotronics, LLC | OLV | Class II | |
| K181646 | Celesteion, PCA-9000A/3, V6.5 | Canon Medical Systems Corporation | JAK | Class II | |
| K181643 | SmartBag (SmartPouch) | 11 Health Technologies Limited | EXB | Class I | |
| K181396 | Oral Device OA, Oral Device S | Passion for Life Healthcare (Uk) Limited | LRK | Class II | |
| K181140 | Axis Chena Cervical PEEK Spacer System | Axis Orthopaedics | ODP | Class II | |
| K181137 | IT-III active System | Neobiotech Co., Ltd. | DZE | Class II | |
| K180979 | PureFlex Arterial Cannulae | Corcym Inc. | DWF | Class II | |
| K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure Cable | Edwards Lifesciences LLC | DQK | Class II | |
| K180645 | Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) | Hartalega Sdn Bhd | LZA | Class I | |
| K180528 | InstruSafe(R) Sterilization Container | Summit Medical, LLC | KCT | Class II | |
| K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Bonraybio Co., Ltd. | POV | Class II | |
| K180184 | Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System | Dentalpoint AG | NHA | Class II | |
| K173373 | SafeT T-Piece Resuscitator | Salter Labs | BTL | Class II | |
| K183117 | PathLoc-L MIS Spinal System | L&K Biomed Co.,Ltd. | NKB | Class II | |
| K182528 | Nitrile Glove Powder Free Black | Haining Medical Products Co., Ltd. | LZA | Class I | |
| K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) | Boston Scientific Corporation | FTM | Class II | |
| K182182 | YUKON OCT Spinal System | K2M, Inc | NKG | Class II | |
| K181998 | CardioBand ECG Event Recorder | Samsung Strategy and Innovation Center (Ssic) | DPS | Class II | |
| K181985 | Voluson E6, Voluson E8, Voluson E10 | GE Healthcare | IYN | Class II | |
| K181897 | Reprocessed Marinr Diagnostic EP Catheter | Innovative Health, LLC. | NLH | Class II | |
| K181831 | IntelliVue Multi-Measurement Module MMX | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | |
| K181750 | Sitzmarks | Konsyl Pharmaceuticals, Inc. | FFX | Class II | |
| K181689 | Nexcomp | Meta Biomed Co., Ltd. | EBF | Class II | |
| K181324 | FilmArray Pneumonia Panel plus | BioFire Diagnostics, LLC | QDS | Class II |