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 |
|---|---|---|---|---|---|
| K223869 | ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine LLC | OVE | Class II | |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | Exactech, Inc. | PHX | Class II | |
| K220034 | NEUROShield | In-Med Prognostics L3c | LLZ | Class II | |
| K232485 | AMSCO 600 Steam Sterilizer | STERIS Corporation | FLE | Class II | |
| K232158 | GenX-CR | Genoray Co., Ltd. | MUH | Class II | |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail | OSSIO, Ltd. | HTY | Class II | |
| K230735 | Ultimate rTMS; Yingchi rTMS | Brain Ultimate, Inc. | OBP | Class II | |
| K230609 | NG Delivery Catheter | Balt USA, LLC | QJP | Class II | |
| K223811 | Lung-CAD | Imagen Technologies, Inc. | MYN | Class II | |
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision BioLogic Inc. | GJT | Class II | |
| K221640 | AlloMap Heart Molecular Expression Testing | Caredx AB | OJQ | Class II | |
| DEN230021 | ensoETM | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | QXV | Class II | |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems Corporation | JAA | Class II | |
| K232459 | Velacur | Sonic Incytes | IYO | Class II | |
| K231892 | Definium Pace Select | GE Hualun Medical Systems Co., Ltd. | KPR | Class II | |
| K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | KWQ | Class II | |
| K231748 | Cartesion Prime (PCD-1000A/3) V10.15 | Canon Medical Systems Corporation | KPS | Class II | |
| K231317 | TrueBeam, TrueBeam STx, Edge, VitalBeam | Varian Medical Systems, Inc. | IYE | Class II | |
| K231112 | Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise N.V. | QHE | Class II | |
| K231011 | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse | Meridian AG | HQF | Class II | |
| K230598 | Stone Extraction Baskets | Jiangsu Vedkang Medical Science and Technology Co.,Ltd. | LQR | Class II | |
| K222938 | Ablation-fit | R.A.W. S.R.L | QTZ | Class II | |
| K213767 | Endure ETCO2/02 Nasal Cannula | Endure Industries, Inc. | CCK | Class II | |
| K232192 | Venus Versa PRO System | Venus Concept Inc. | ONF | Class II | |
| K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation | Mirus, LLC | OVD | Class II | |
| K232002 | Vantage® Total Ankle System | Exactech, Inc. | HSN | Class II | |
| K231746 | VERIFY Spore Test Strip for S40 Sterilant Concentrate | STERIS Corporation | OVY | Class II | |
| K231504 | TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System | Vilex LLC | HWC | Class II | |
| K231283 | SiteRite™ 9 Ultrasound System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | IYO | Class II | |
| K230881 | Change Healthcare Cardiology Hemodynamics™ | Change Healthcare Israel Ltd. | MWI | Class II | |
| K230517 | Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) | Jarmon Medical, LLC (dba Legends Orthopedics) | MBI | Class II | |
| K230362 | Planar LED mate | Shenzhen Leaflife Technology Co., Ltd. | OHT | Class II | |
| K223755 | i-STAT G cartridge with the i-STAT 1 System | Abbott Medical | CGA | Class II | |
| K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial | Brainlab, Inc. | HAW | Class II | |
| K232686 | CorVista® System | Corvista Health, Inc. | QXX | Class II | |
| K232457 | Q-FIX ULTRA All-Suture Anchor | Smith & Nephew, Inc. | MBI | Class II | |
| K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts | ConforMIS, Inc. | MBH | Class II | |
| K232414 | Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post | Total Joint Othopedics, Inc. | JWH | Class II | |
| K232413 | Fusion Robotic Navigation System | Alphatec Spine, Inc. | OLO | Class II | |
| K232400 | VariSeed (v10) | Varian Medical Systems, Inc. | MUJ | Class II | |
| K232386 | ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6 | Abbott Medical | NQQ | Class II | |
| K232166 | PreXion3D Expedition | Prexion Corporation | OAS | Class II | |
| K231729 | Sterile syringes for single use with/without needle | Wepon Medical Technology Co., Ltd. | FMI | Class II | |
| K231727 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Wepon Medical Technology Co., Ltd. | FMF | Class II | |
| K231723 | Sterile Safety Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. | FMI | Class II | |
| K231720 | Sterile Hypodermic Needles for Single Use | Wepon Medical Technology Co., Ltd. | FMI | Class II | |
| K231643 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Syntex Healthcare Products Co., Ltd. | LZA | Class I | |
| K231471 | Air/Water Bottle Tubing, CO2 Source Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. | OCX | Class II | |
| K231335 | Cleerly ISCHEMIA | Cleerly, Inc | QXZ | Class II | |
| K231284 | OnPoint Augmented Reality Spine System | Onpoint Surgical | SBF | Class II |