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 |
|---|---|---|---|---|---|
| K051324 | Medi Butler | Medi USA, LP | DWL | Class II | |
| K050726 | Silverseal Silveraid with X-Static | Noble Fiber Technologies, Inc. | FRO | Unclassified | |
| K050642 | Orthoblast II Putty and Paste | IsoTis OrthoBiologics, Inc. | MBP | Class II | |
| K050150 | Mani Needle & Suture Pack | Mani, Inc. | GAT | Class II | |
| K043209 | Viagraf Dbm Paste | Osteotech Inc | MBP | Class II | |
| K053152 | Biohorizons Single-Stage Implant | BioHorizons Implant Systems Inc | DZE | Class II | |
| K053105 | Synthes (USA) Elastic Intramedullary Nail (Ein) End Cap | Synthes (USA) Products LLC | HSB | Class II | |
| K052748 | System 12 X3 Acetabular Inserts; Series II X3 Acetabular Inserts | Howmedica Osteonics Corp | JDI | Class II | |
| K052348 | In Vision Gold with Spin Vision, Model 891 Sv | Volcano Corporation | IYO | Class II | |
| K051736 | Fox Pulse Oximeter | Shunsuke Nakanishi | DQA | Class II | |
| K053248 | Smartvest Airway Clearance System, Model Tl | Electromed, Inc. | BYI | Class II | |
| K053186 | Vitek 2 Gram Positive Telithromycin for Streptococcus Pneumoniae | bioMerieux, Inc. | LON | Class II | |
| K053080 | Graftcage Acx | Osteotech Inc | MQP | Class II | |
| K052395 | Sterile Equipment Covers | Volcano Corporation | KKX | Class II | |
| K052388 | Serim Peracetic Acid Chemical Indicator | Serim Research Corp. | JOJ | Class II | |
| K052184 | Given Diagnostic System | Given Imaging Ltd. | NSI | Class II | |
| K051964 | Powerneb | Comedica, Inc. | NHJ | Class II | |
| K051858 | Acumatch M-Series Lpb 12/14 Femoral Stem | Exactech, Inc. | LZO | Class II | |
| K053128 | Soloist Single Needle Electrodeelectrode | Boston Scientific Corporation | GEI | Class II | |
| K053126 | Binaxnow Influenza a & B Test | Binax, Inc. | PSZ | Class II | |
| K053083 | Datrix Cardio Wifi Electrocardiograph | Datrix LLC | DPS | Class II | |
| K053082 | Baylis Pain Management Cooled Probe, Model Pmpc-18-150-6 | Baylis Medical Co., Inc. | GXI | Class II | |
| K052980 | Liberty Glucose Control, Model 2120031 | Liberty Healthcare Group, Inc. | JJX | Class I | |
| K052892 | Synthalon Pc Plus Powder-Free Polychloroprene Examination Gloves, Models 1372-11 to 1272-55 | Barriermed Glove Co. | LZA | Class I | |
| K052814 | Lumina 1600, 3300 and 6600 Systems | USA Laser Biotech, Inc. | ILY | Class II | |
| K052675 | Synergeyes Kc (Paflufocon D Hem-Iberfilcon a) Hybrid Contact Lens for Keratoconus | Synergeyes, Inc. | HQD | Class II | |
| K052662 | One Step Fsh Menopausal Test | Ind Diagnostic, Inc. | CGJ | Class I | |
| K052610 | Image Star II | Lakeshore Technologies, Inc. | JAA | Class II | |
| K052477 | Damon 3 Modified | Ormco Corp. | DYW | Class II | |
| K052339 | Asahi Ptca Guide Wire | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K051401 | On-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow Catheter | Halyard Health | BSO | Class II | |
| K051280 | Medcomp Split Cath II | Medcomp | MSD | Class II | |
| K042707 | Grafton Plus Dbm Paste | Osteotech Inc | NUN | Class II | |
| K052432 | Medtronic Minimed Paradigm Leapfrog II Infusion Set, Models Mmt-802S1, Mmt-802L1, Mmt-802S2, Mmt-802L2 | Medtronic, Inc. | FPA | Class II | |
| K052431 | Medtronic Minimed Leapfrog II Infusion Set, Models Mmt-801S1, Mmt-801L1, Mmt-801S2, Mmt-801L2, Mmt-803S1 | Medtronic, Inc. | FPK | Class II | |
| K052387 | Arthrex Fingershield Finger Guard, Model Ar-7199-Xx | Arthrex GmbH | LZB | Class I | |
| K051925 | Carestart Cardiac 3-in-1 Troponin 1/Ck-Mb/myoglobin | Access Bio Incorporate | MMI | Class II | |
| K053098 | Optium Dbm Gel and Putty | Lifenet | MBP | Class II | |
| K053059 | Roche Diagnostics Elecsys Prolactin II Calcheck | Roche Diagnostics GmbH | JJX | Class I | |
| K052900 | Quill Nonabsorbable Nylon Barbed Suture | Quill Medical, Inc. | GAR | Class II | |
| K052568 | Esteem Stretchy Vinyl Glove with Coating | Cardinalhealth | LYZ | Class I | |
| K052481 | Bd Viper System | Becton Dickinson & Co | LSL | Class II | |
| K052401 | Gynecare Tvt Secur System | Ethicon, Inc | PAH | Class II | |
| K052667 | Artsana Piston and Insulin Syringes | Artsana S.P.A | FMF | Class II | |
| K052578 | Bard G2 Filter System - Jugular/subclavian Delivery Kit, Model RF-320J | Bard Peripheral Vascular Inc | DTK | Class II | |
| K051821 | Inion S-1 Biodegradable Anterior Cervical Fusion System | Inion Oy | OJB | Class II | |
| K051114 | Sentinel Ammonia Ultra Diagnostic Assay | Sentinel CH SpA | JIF | Class I | |
| K053155 | Vimplant | Cybermed Inc. | LLZ | Class II | |
| K053054 | Thrombix 3X3 Hemostatic Pad | Vascular Solutions LLC | QSX | Unclassified | |
| K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | IYN | Class II |