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 |
|---|---|---|---|---|---|
| K231884 | TRIOCLEAR System | Modern Dental Laboratory (DG) Co., Ltd. | NXC | Class II | |
| K231710 | Ow100s | Softwave/Trt, LLC | PZL | Class II | |
| K231270 | Montage Flowable Settable, Resorbable Bone Paste | Orthocon, Inc. | MQV | Class II | |
| K231047 | UniSyn Molecular Imaging (6-3-1) | Convergent Imaging Solutions | LLZ | Class II | |
| K230918 | MasterX 800 Series | Medicatech USA | MQB | Class II | |
| K230805 | TriMed Clavicle Fixation System | Trimed Inc | HRS | Class II | |
| K230623 | KITE Distal Fibula Kit | Intrauma | HRS | Class II | |
| K230317 | Elos Accurate Hybrid Base | Elos MedTech Pinol a/S | NHA | Class II | |
| K223901 | ApneaRX Pro | Apnea Sciences Coporation | LRK | Class II | |
| K223674 | eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) | Epic Medical Pte., Ltd. | KPE | Class II | |
| K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK) | Faceheart Corp. | QME | Class II | |
| K222988 | neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical | Ht Medical D.B.A. Xenix Medical | ODP | Class II | |
| K221601 | Ms-39 | C.S.O. S.r.l. | OBO | Class II | |
| K213413 | Hemostatic Dressing | Jiangsu Newvalue Medical Products Co., Ltd. | QSY | Unclassified | |
| K213273 | Brain Anesthesia Response Monitor (Bar Monitor) | Cortical Dynamics, Ltd. | OLW | Class II | |
| DEN230007 | LightStrike+ (MXSUV1-SL and MXSUV1-FT) | XENEX Disinfection Services Inc. | QXJ | Class II | |
| K232353 | Powder Free Nitrile Examination Gloves (Black) | Shanxi Hongjin Plastic Technology Co., Ltd | LZA | Class I | |
| K232287 | RAYSCAN a-Expert3D | Ray Co., Ltd. | OAS | Class II | |
| K231978 | BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50 | Vivachek Biotech (Hangzhou) Co., Ltd | NFW | Class II | |
| K231626 | OSPREY Closed IV Catheter System (OspreyV2) | Skydance Vascular, Inc. | FOZ | Class II | |
| K231616 | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | Zeus Scientific LLC | KTL | Class II | |
| K231611 | HOLO Portal™ Surgical Guidance System | Surgalign Spine Technologies | SBF | Class II | |
| K231433 | The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL | Thermo Fisher Scientific Oy | NGZ | Class II | |
| K231323 | Ancora-SB | Aspero Medical, Inc. | FDA | Class II | |
| K230578 | Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | WRP Asia Pacific Sdn Bhd | KGO | Class I | |
| K230488 | EL27-Compact; Sterile EHL-Probes | Walz Elektronik GmbH | FFK | Class II | |
| K223597 | 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | 23AndMe, Inc. | QAZ | Class II | |
| K223533 | Little Wave Arc; Little Wave Flip | Ki Mobility | LBE | Class I | |
| K223527 | Little Wave Clik, Rogue XP, Little Wave XP, Spark | Ki Mobility | IOR | Class I | |
| K222563 | BD Kiestra IdentifA | Becton Dickinson & Co | QQV | Class II | |
| K221959 | Q21 | Neurofield, Inc. | GWQ | Class II | |
| K213271 | MedicloseTM System | Health Value Creation B.V., Trading AS Corporis Medical | OCW | Class II | |
| K232343 | AC3™ Series IABP | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | Class II | |
| K232324 | StealthFix Intraosseous Fixation System | Medartis AG | JDR | Class II | |
| K232295 | LAA Exclusion System | Syntheon, LLC | PZX | Class II | |
| K231988 | Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml | Thermo Fisher Scientific Oy | JWY | Class II | |
| K231961 | NIBPCuff | Shenzhen Sino-K Medical Technology Co., Ltd. | DXQ | Class II | |
| K231656 | Brainomix 360 e-MRI | Brainomix Limited | LLZ | Class II | |
| K231580 | NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | Medtronic Xomed, Inc. | ETN | Class II | |
| K231289 | S-Patch Ex Wearable ECG Patch | Wellysis Corp. | DSH | Class II | |
| K231276 | SmartCardia 7L Platform | Smartcardia SA | DSI | Class II | |
| K231246 | Ventrax™ Delivery System (VTR851) | Merit Medical Systems, Inc. | DQY | Class II | |
| K231156 | Enzyme Packed Cartridge - RELiZORB | Alcresta Therapeutics, Inc. | PLQ | Class II | |
| K231123 | Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) | Phoenix Innovative Healthcare Manufacturers Pvt., Ltd. | LRX | Class II | |
| K231093 | AlphaVent Suture Anchors | Stryker Corp. | MBI | Class II | |
| K231024 | AquaBeam Robotic System | PROCEPT BioRobotics Corporation | PZP | Class II | |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) | Teleflex Medical | BSO | Class II | |
| K230355 | Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | |
| K230155 | Mick Valencia Applicator Set | Mick Radio-Nuclear Instruments, Inc. | JAQ | Class II | |
| K230013 | Silk'n Titan Allways | Silk'n Beauty Ltd. | PAY | Class II |