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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K212121 | VHT-200 Wound Treatment System | Vaporox, Inc. | KPJ | Class II | |
| K230583 | Tryptik Ti | Spineart SA | ODP | Class II | |
| K230533 | Motive™ Electrode | Cymedica Orthopedics, Inc. | GXY | Class II | |
| K230194 | HF Surgery Generator 400KHZ | Richard Wolf Medical Instruments Corp. | GEI | Class II | |
| K230191 | Arise™ UHP Dilatation Catheter | Creagh Medical Ltd. | LIT | Class II | |
| K230142 | Epi-Stop Nasal Gel/epistaxis pack | Biomed ENT, Inc | LYA | Class I | |
| K223889 | Stativ® Knotted UHMWPE Suture Anchor | Healthium MedTech Limited | MBI | Class II | |
| K223837 | SPIRA®-C Integrated Fixation System | Camber Spine Technologies | OVE | Class II | |
| K223824 | POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor | Boston Scientific Corporation | DRA | Class II | |
| K223593 | Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar | Taiwan Surgical Corporation | GCJ | Class II | |
| K223086 | Ceribell Instant EEG Headcap | Ceribell, Inc. | GXY | Class II | |
| K223049 | CardioSTAT® ECG Test Solution | ICENTIA Inc | DSH | Class II | |
| K222036 | Mpxa-2000 | Medipixel, Inc. | QIH | Class II | |
| K221402 | CEREC Tessera Abutment Block, CEREC Tessera Abutment System | Dentsply Sirona Inc | NHA | Class II | |
| K220464 | Tigon Medical Gryphon Anchor Line | Tigon Medical LLC | MBI | Class II | |
| K213362 | BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel | BioFire Defense, LLC | QVR | Class II | |
| K230561 | Syngo Carbon Space VA30A | Siemens Healthcare GmbH | LLZ | Class II | |
| K230520 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) | Barco N.V. | PGY | Class II | |
| K230471 | LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface | Waldemar Link GmbH & Co. KG | JWH | Class II | |
| K230054 | DSM Biomedical Calcium Phosphate Cement | DSM Biomedical, Inc. | MQV | Class II | |
| K223844 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) | Thermo Fisher Scientific Oy | JWY | Class II | |
| K223708 | Entasis 3D Dual-Lead Sacroiliac Implant System | Corelink, LLC | OUR | Class II | |
| K223672 | Instrument Case P1340904 | Cochlear Ltd | KCT | Class II | |
| K223490 | FlightPlan for Embolization | GE Medical Systems SCS | LLZ | Class II | |
| K222709 | Retraction, CWM-910T, APOLEX Tite | Chungwoo Co., Ltd. | GEI | Class II | |
| K222617 | EasyTouch Lancing Device | Stat Medical Devices, Inc. | QRK | Class II | |
| K220026 | Genomadix Cube CYP2C19 System | Genomadix Inc | NTI | Class II | |
| K214070 | OviTex PRS (Long Term Resorbable) | Tela Bio, Inc. | FTM | Class II | |
| K230174 | TENS and EMS Stimulation (OTC) | Changsha Yuwen Medical Equipment Co., Ltd. | NUH | Class II | |
| K230163 | TENS and EMS Stimulation (OTC) | Changsha Yuwen Medical Equipment Co., Ltd. | NUH | Class II | |
| K223875 | MOBINEURO Alita Intraoperative MRI System | Sino Canada Health Engineering Research Institute (Hefei) | LNH | Class II | |
| K223245 | Colibrí | Copan WASP | QQV | Class II | |
| K223043 | The Integrity Spine Core System | Integrity Spine | ODP | Class II | |
| K222828 | Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A | WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. | GCJ | Class II | |
| K222417 | Shina Safety Needle | Shina Corporation | FMI | Class II | |
| K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics Inc. | CIG | Class II | |
| K221996 | P-Cure Proton Beam Therapy System | P-Cure, Ltd. | LHN | Class II | |
| K220725 | HPR45i | F Care Systems USA | GEI | Class II | |
| K221841 | EOlife® | Archeon | BTM | Class II | |
| K221808 | InterOss Collagen | Sigmagraft, Inc. | NPM | Class II | |
| K230441 | EMPOWR Stem Extender, 50mm | Encore Medical, L.P dba Enovis | JWH | Class II | |
| K230435 | Arthrex 3.9 mm SwiveLock Anchor | Arthrex GmbH | MAI | Class II | |
| K230141 | LOQTEQ® VA Elbow Plates 2.7/3.5 System | AAP Implantate AG | HRS | Class II | |
| K230115 | Denture Base Resin | Aidite (Qinhuangdao) Technology Co., Ltd | EBI | Class II | |
| K223878 | Aevumed RAPID Suture Anchors | Aevumed, Inc. | MBI | Class II | |
| K223666 | Ablacath™ Mapping Catheter | Ablacon, Inc. | MTD | Class II | |
| K223613 | InThrill Thrombectomy System | Inari Medical, Inc. | QEW | Class II | |
| K223443 | Viz AAA | Viz. Ai, Inc. | QFM | Class II | |
| K223418 | DeGen Impulse AM™ System | Degen Medical | MAX | Class II | |
| K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT | Healgen Scientific LLC | LDJ | Class II |