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 |
|---|---|---|---|---|---|
| K221642 | SIRIUS Endoscope System | Precision Robotics (Hong Kong) Limited | HET | Class II | |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | Ortho-Clinical Diagnostics, Inc. | LTK | Class II | |
| K220926 | Spectra Wearable | Uzinmedicare Co., Ltd. | HGX | Class II | |
| K220921 | Metal Bone Screw | Double Medical Technology Inc. | HWC | Class II | |
| K212957 | BioButton System | Biolntellisense, Inc. | DRG | Class II | |
| K202674 | Medidenta High Speed Handpieces | Pac-Dent Inc. | EFB | Class I | |
| K222733 | Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) | Inner Mongolia Boming Medical Supplies Co., Ltd. | LZA | Class I | |
| K223403 | LIAISON Anti-HAV; LIAISON XS | Diasorin Inc. | LOL | Class II | |
| K223402 | HemosIL von Willebrand Factor Antigen | Instrumentation Laboratory Co. | GGP | Class II | |
| K223275 | CELLO II Balloon Guide Catheter | Fuji Systems Corp. | QJP | Class II | |
| K223195 | AIROS 6P Sequential Compression Device | Airos Medical Inc | JOW | Class II | |
| K223193 | AIROS 8P Sequential Compression Device | Airos Medical Inc | JOW | Class II | |
| K222916 | US 450 Diode Laser Equipment | Beijing Globalipl Development Co., Ltd. | GEX | Class II | |
| K222753 | SeaSpine 7D Navigation Instruments | SeaSpine Orthopedics Corporation | OLO | Class II | |
| K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | Stryker Craniomaxillofacial (Cmf) | JEY | Class II | |
| K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) | Stryker Corp. | JCX | Class II | |
| K222242 | FloPatch FP120 | Flosonics Medical | DPW | Class II | |
| K222117 | Swang-Ganz IQ pulmonary artery catheter | Edwards Lifesiences, LLC | DYG | Class II | |
| K222086 | Inogen Rove 4 Portable Oxygen Concentrator | Inogen, Inc | CAW | Class II | |
| K221598 | Wearable breast pump | Mayborn (UK) Limited | HGX | Class II | |
| K221280 | Vesseal | Lydus Medical, Ltd. | GAW | Class II | |
| K220951 | PMT Facet Fixation System (PMT FFS) | Providence Medical Technology, Inc. | MRW | Unclassified | |
| K220822 | 3D-Shaper | 3D-Shaper Medical S.L. | KGI | Class II | |
| K220774 | RobPath® Total Hip Application | Hangzhou Lancet Robotics Co., Ltd. | OLO | Class II | |
| K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe | MEDLINE INDUSTRIES, LP - Northfield | FMF | Class II | |
| K223487 | InkSpace Imaging Body Array | Inkspace Imaging, Inc | MOS | Class II | |
| K223239 | 8ch Wrist Coil | Shenzhen RF Tech Co., Ltd. | MOS | Class II | |
| K223112 | MAVERICK Mini External Fixation System | Smith & Nephew, Inc. | JDW | Class II | |
| K222837 | Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters | Spectranetics Corp. | MCW | Class II | |
| K222750 | Yomi Robotic System | Neocis Inc. | QRY | Class II | |
| K222471 | IRRAflow Active Fluid Exchange System (AFES) | Irras USA, Inc. | JXG | Class II | |
| K222038 | CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System | Abbott (Formerly Thoratec Corporation) | QNR | Class II | |
| K221862 | YY-A02-B Overlapped Compression Therapy | Huizhou Xinyi Technology Co., Ltd | IRP | Class II | |
| K221444 | LED Eye Perfector, model: EY-36A, EY-36B | Light Tree Ventures Europe B.V. | OHS | Class II | |
| K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF) | Southern Medical (Pty) Ltd | MAX | Class II | |
| K220826 | LED Curing Light | Foshan Coxo Medical Instrument Co., Ltd. | EBZ | Class II | |
| K220667 | Sleeved IC | Hollister Incorporated | EZD | Class II | |
| K213210 | Oxygen Concentrator, Model JAY-5AW | Longfian Scitech Co., Ltd. | CAW | Class II | |
| K211800 | Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer | Quality in Flow Ltd. | LGZ | Class II | |
| K223410 | Cios Select (VA21) Flat Panel | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K223394 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) | Visionary Optics, LLC | HQD | Class II | |
| K223281 | Disposable Nitrile Examination Glove | Anhui Kindguard Medical Supplies Technology Co.,Ltd | LZA | Class I | |
| K223077 | ViewFlex Xtra ICE Catheter | Irvine Biomedical, A St. Jude Medical Company | OBJ | Class II | |
| K223045 | 3-Ply Disposable Medical Mask | Wealth Lead Industrial Limited | FXX | Class II | |
| K222441 | Ultrasound System 2300 | BK Medical ApS | IYN | Class II | |
| K221842 | Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF | Roche Diagnostics GmbH | QSE | Class II | |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | Drägerwerk AG & Co. KGaA | CAH | Class II | |
| K221626 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate | JR Engineering and Medical Technologies (M) Sdn Bhd | LZA | Class I | |
| K220843 | OAKTREE Anterior Lumbar Plate and Screw System | Oak Tree Engineering, LLC | KWQ | Class II | |
| K220772 | HydroMID 4F Single Lumen Midline Catheter | Access Vascular, Inc | FOZ | Class II |