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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K013863 | Crystal Monitor Model 16 | Cleveland Medical Devices, Inc. | OMC | Class II | |
| K013219 | Protoco2l Insufflator Model 6400 | E-Z-EM, Inc | FCX | Class II | |
| K020385 | Cgs-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model Tsx-101A | Toshiba America Medical Systems, In.C | JAK | Class II | |
| K020251 | Paragon Infusion System | Halyard Health | FRN | Class II | |
| K020235 | A1cnow for Professional Use | Metrika, Inc. | LCP | Class II | |
| K020234 | A1cnow for Rx Home Use | Metrika, Inc. | LCP | Class II | |
| K020196 | Modification to Silhouette Spinal Fixation System | Zimmer Spine, Inc. | MNH | Class II | |
| K020144 | Siemens Infinity Sc 6002Xl Modifications | Siemens Medical Solutions USA, Inc. | DRT | Class II | |
| K020122 | Mb 102 Millennium Blades | Millennium Biomedical, Inc. | HNO | Class I | |
| K014284 | Nitrile Patient Examination Gloves, Powder-Free and Yellowish White | Formosa Glove Industrial Co., Ltd. | LZA | Class I | |
| K014173 | Synchron Systems Salicylate Reagent and Calibrator | Siemens Healthcare Diagnostics Inc. | DKJ | Class II | |
| K014005 | Apple Medical Mobius Elastic Retractor | CooperSurgical, Inc. | GCJ | Class II | |
| K013825 | Candela Smoothbeam Laser System | Candela Corporation | GEX | Class II | |
| K013397 | Pacific Hemostasis Reference Emulsion | Fisher Diagnostics | JIX | Class II | |
| K013342 | Excelsior Test Strips, for Use with the Home Diagnostics, Inc. | Chay Medical, LLC | CGA | Class II | |
| K013276 | All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque) | Sewoon Medical Co., Ltd. | EZL | Class II | |
| K012472 | A & D Medical Lifesource Ua-781, Ua781pc, & Ua-781T Digital Blood Pressure Monitors | A and D Engineering, Inc. | DXN | Class II | |
| K011863 | Vcs-a Series Clamp | Vascular Control Systems, Inc. | DXC | Class II | |
| K011833 | Mb 103 Millennium Blades | Millennium Biomedical, Inc. | HNO | Class I | |
| K011147 | Cavitat Ultrasound Bone Densitometer (Cavitat) | Cavitat Medical Technologies, Inc. | EHD | Class II | |
| K020317 | Non-Sterile Powder Free Green Barrier-Pro Synthetic Butadiene Copolymer Examination Glove, Color: Blue | Sgmp Co., Ltd. | LZA | Class I | |
| K020304 | Disposable Light Handle and Adaptor | Aspen Surgical Products, Inc. | FTA | Class II | |
| K020293 | Osteonics Spinal System | Howmedica Osteonics Corp | MNH | Class II | |
| K020236 | Modification to Pass Spinal System | Encore Orthopedics, Inc. | KWP | Class II | |
| K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | DQK | Class II | |
| K020062 | Xerafit | Metalor Technologies USA | EJH | Class II | |
| K020050 | Enamel Bonding System | Rite-Dent Manufacturing Corp. | KLE | Class II | |
| K014285 | Nitrile Patient Examination Gloves, Powder-Free, Purple | Formosa Glove Industrial Co., Ltd. | LZA | Class I | |
| K014129 | Promogran Matrix Wound Dressing | Johnson & Johnson MEDICAL GmbH | KGN | Unclassified | |
| K014036 | Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2Nd Skin Silicone Scar Therapy Gel, Model 09916030. | Medtrade Products Ltd. | MDA | Class I | |
| K013542 | Dentin Conditioning and Adhesive System (Bond-1) | Jeneric/Pentron, Inc. | KLE | Class II | |
| K012685 | Reprocessed Endoscopic Electrodes | Sterilmed Inc | NLW | Class II | |
| K012581 | Reprocessed Stone Retrieval Baskets | Sterilmed Inc | FFL | Class II | |
| K011239 | Ginda Guard | Cosmedent, Inc. | EBD | Class II | |
| K994055 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | FRC | Class II | |
| K020353 | Omnia X/xs Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II | |
| K014288 | Dermgrip Powder Free Polymer Coated Latex Surgeon's Gloves,sterile with Protein Content Labeling Claim (50 Microgram Ors | Wrp Specialty Products Sdn. Bhd. | KGO | Class I | |
| K014185 | Aos Cannulated Bone Screw System | Advanced Orthopaedic Solutions, Inc. | HWC | Class II | |
| K014107 | Endius Cervical Plate System | Endius, Inc. | KWQ | Class II | |
| K014073 | Hypodermic Needle-Pro Insulin Syrine & Needle with Needle Protection Device | Abbott Medical | FMF | Class II | |
| K013998 | Powder-Free Lavender/purple Nitrile Exam Gloves | Sheen More Ent. Co., Ltd. | LZA | Class I | |
| K013979 | Sc-Acufix Thinline Anterior Cervical Plate System | Spinal Concepts, Inc. | KWQ | Class II | |
| K013803 | Flowguard Device | Biosonix, Ltd. | DPW | Class II | |
| K013312 | P.l.u.s. System (Pivot Link Universal System) | Spine Vision, Inc. | KWP | Class II | |
| K013301 | Uni-T Spinal System | Spine Vision, Inc. | MNI | Class II | |
| K020362 | P.o.g.s. 3.3 Portable Oxygen Generator System | On Site Gas Systems Inc. | CAW | Class II | |
| K020301 | Modification to Vista Stereoscope System | Vista Medical Technologies, Inc. | FET | Class II | |
| K020295 | Nexgen Lps Trabecular Metal Monoblock Tibia; Zimmer Cat # 00-5886-Xxyy, Implex Part # 05-121-Xxyy-0 | Implex Corp. | JWH | Class II | |
| K020232 | Hypoguard Advance Blood Glucose Monitoring System | Arkray Factory USA, Inc. | CGA | Class II | |
| K020164 | E-Scan Xq | Esaote North America, Inc | LNH | Class II |