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 |
|---|---|---|---|---|---|
| K230877 | Admira Fusion 5 | Voco GmbH | EBF | Class II | |
| K230863 | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit | Zeus Scientific LLC | LSR | Class II | |
| K230611 | X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) | Xstrahl Limited | JAD | Class II | |
| K223728 | Micro Rx | IMDS Operations B.V. | DQY | Class II | |
| K223426 | ECHELON Synergy MRI system | Fujifilm Healthcare Corporation | LNH | Class II | |
| K223424 | Spine Auto Views | GE Medical Systems SCS | JAK | Class II | |
| K223261 | Open Rib | Canon Medical Informatics, Inc. | JAK | Class II | |
| K223125 | Xr90 (Xr90-Sys) | Mediview XR | LLZ | Class II | |
| K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) | Siemens Healthcare Diagnostics Inc. | JLW | Class II | |
| K221961 | HydroMARK Plus Breast Biopsy Site Marker | Devicor Medical Products Inc | NEU | Class II | |
| K231714 | Graftys Quickset | Graftys | MQV | Class II | |
| K231709 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 | RadmediX, LLC | MQB | Class II | |
| K231241 | NanoHive Medical Lumbar Interbody System | NanoHive Medical LLC | MAX | Class II | |
| K231035 | FusedCO Algorithm | Edwards Lifesciences LLC | DQK | Class II | |
| K230823 | AusculThing ACC | Ausculthing Oy | DQD | Class II | |
| K230532 | RADx Intraoral Appliance for Snoring and Sleep Apnea | Achaemenid, LLC | LQZ | Class II | |
| K223808 | Zavation Navigation Instrument System | Zavation Medical Products, LLC | OLO | Class II | |
| K223631 | Comprehensive Segmental Revision System(SRS) | Biomet Orthopedics, Inc. | KWT | Class II | |
| K231925 | MINIMA S System | Lima Corporate S.p.A. | LZO | Class II | |
| K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System | Nu Vasive, Incorporated | ODP | Class II | |
| K231711 | microINR System | Iline Microsystems S.L. | GJS | Class II | |
| K231528 | Bonalive Orthopedics granules | Bonalive Biomaterials, Ltd. | MQV | Class II | |
| K231386 | Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste | Orthocon, Inc. | MTJ | Unclassified | |
| K230942 | SPIRA® Posterior Lumbar Spacers | Camber Spine Technologies | MAX | Class II | |
| K230680 | Anthogyr Surgical Cassettes | Anthogyr | KCT | Class II | |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | LFL | Unclassified | |
| K230307 | Dentis i-Clean System | Dentis Co.,Ltd | NHA | Class II | |
| K221137 | Play and Joy Water-Based Lubricant | Innovemed Bio-Tech Co., Ltd. | NUC | Class II | |
| K231701 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | OWB | Class II | |
| K231412 | CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) | Biosense Webster Inc | DYB | Class II | |
| K231387 | Endofill | Lumendo AG | KIF | Class II | |
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID | Biosense Webster Inc | MTD | Class II | |
| K231091 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | |
| K223724 | Mozi Tps | Manteia Technologies Co.,Ltd. | MUJ | Class II | |
| K223683 | EnteraLoc Flow | Vonco Products, LLC | PIF | Class II | |
| K223213 | Tandem Mobi Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | QFG | Class II | |
| K222666 | X-View 3D Pan/X-View 2D Pan | Trident SRL | OAS | Class II | |
| K221307 | Edge Upper Cervical System | Spinal Simplicity, LLC | NKG | Class II | |
| K220646 | Play&Joy InvisiLube Lubricant Capsule | Innovemed Bio-Tech Co., Ltd. | NUC | Class II | |
| K232011 | Cleo | American Orthodontics | NJM | Class II | |
| K231844 | ProMIS™ Fixation System | Premia Spine Ltd. | NKB | Class II | |
| K231668 | Spine CAMP™ (1.1) | Medical Metrics, Inc. | QIH | Class II | |
| K231318 | Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) | Beijing Adss Development Co., Ltd. | NGX | Class II | |
| K231253 | Overture Orthopaedics Patellofemoral System | Overture Resurfacing, Inc. | KRR | Class II | |
| K230932 | ANDORATE® Valve Kit | GA Health Company Limited | OCX | Class II | |
| K230804 | Complement Kit Cases | JJGC Industria e Comercio de Materiais Dentarios SA | KCT | Class II | |
| K230080 | Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood | Yangzhou Medline Industry Co., Ltd. | JKA | Class II | |
| K223578 | T3 Platform software | Etiometry Inc. | PPW | Class II | |
| K223448 | Bladder Scanner Model: BVT02 | Xuzhou Kaixin Electronic Instrument Co., Ltd. | IYO | Class II | |
| K223388 | Invia® Integrated Dressing | Medela AG | OMP | Class II |