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 |
|---|---|---|---|---|---|
| K003035 | Clarren Helmet | Children'S Hospital & Medical Center | MVA | Class II | |
| K002846 | Headstar's Manual Emergency Resuscitator | Headstar Medical Products Co., Ltd | BTM | Class II | |
| K002410 | Freed Bioelectric: Dysphagia Treatment Device | Dysphagia, LLC | IPF | Class II | |
| K001917 | Parodi Catheter for Angiography (Parca) | Arteria Medical Science, Inc. | MJN | Class II | |
| K011580 | Simplicity Soft Qd Silver Infusion Set | Sterling Medivations, Inc. | FPA | Class II | |
| K011563 | Powder Free Latex Examination Gloves with Water Extractable Protein Labeling Claim | U.O.P. Rubber Products Sdn Bhd | LYY | Class I | |
| K011442 | Abbott Plum A+infusion Pump, Model 11971 | Abbott Medical | FRN | Class II | |
| K011428 | Triceram | Dentaurum Inc. | EIH | Class II | |
| K011425 | Carmen | Dentaurum Inc. | EIH | Class II | |
| K011414 | Powdered Vinal Exam Gloves | Heyuan Hongli Industries, Inc. | LYZ | Class I | |
| K011413 | Powder-Free Vinyl Exam Glove, Yellow | Heyuan Hongli Industries, Inc. | LYZ | Class I | |
| K011179 | Deldent Ultrasonic Inserts | Deldent, Ltd. | ELC | Class II | |
| K011029 | Modification to Tsrh Spinal System | Medtronic Sofamor Danek | MNI | Class II | |
| K010824 | Personal Infusor Local Pain Management Procedural Kit | Science Incorporated | MEB | Class II | |
| K010701 | Medtronic Sofamor Danek Biphasic Calcium Phosphate (Bcp) Bone Void Filler | Medtronic Sofamor Danek USA Inc | LYC | Class II | |
| K010682 | Helax-Tms V 5.1 Radiation Therapy Treatment Planning System | Mds Nordion | MUJ | Class II | |
| K010429 | Accutni and Accutni Calibrators on the Access Immunoassay System # 33340, 33345 | Siemens Healthcare Diagnostics Inc. | MMI | Class II | |
| K003543 | Stryker Painpump Pca | Stryker Corp. | FRN | Class II | |
| K010669 | Neurograph Evoked Potential Systems (Eps), Model Eps-1 | Thuris Corp. | GWQ | Class II | |
| K010667 | Gambro Polyflux 24S, Gambro Polyflux 24R | Gambro Renal Products | KDI | Class II | |
| K010658 | Modified Uss Fracture System | Synthes (USA) Products LLC | MNI | Class II | |
| K010122 | Continuous Flow Y-Tubing | G.U.-Tek | LJH | Class II | |
| K003538 | Tdp Cq-27 Heat Lamp | Lhasa Medical, Inc. | ILY | Class II | |
| K003472 | Integra Oxygen Concentrators Model 6400-Om | Sequal Technologies, Inc. | CAW | Class II | |
| K011587 | Sentinel Enteral Feeding Pump, Lh2001 Enteral Feeding Pump | Entracon Corp. | LZH | Class II | |
| K011366 | Custom Tci-Combi (Tinnitus Control Instrument Combination) | Siemens Hearing Instruments, Inc. | KLW | Class II | |
| K011020 | Denver Pleural Effusion Shunt with External Pump Chamber | Denver Biomedicals, Inc. | KPM | Class II | |
| K010315 | Iscreen Vision Screener | Iscreen, LLC | HKI | Class II | |
| K010226 | Verdict -II Methamphetamine | MEDTOX Diagnostics, Inc. | DJC | Class II | |
| K010009 | Koko Peak Kp; Koko Peak Kp+ | Pds Healthcare Products, Inc. | BZH | Class II | |
| K003992 | Percusurge Guardwire Temporary Occlusion and Aspiration System | Percu Surge, Inc. | NFA | Class II | |
| K003973 | Respiratory Humidifier, Model Hc150 | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K003741 | Jet Syringe Model-100500 | Equidyne Systems, Inc. | KZE | Class II | |
| K002405 | Spinal Epidural Needles | Te ME NA S.A.R.L. | BSP | Class II | |
| K011474 | Powdered Synthetic (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Junfei Plastic Products Co., Ltd. | LYZ | Class I | |
| K011430 | Actiware-Plms | Mini-Mitter Co., Inc. | GWQ | Class II | |
| K011412 | Powder-Free Vinyl Exam Gloves | Heyuan Hongli Industries, Inc. | LYZ | Class I | |
| K011152 | Vasotrac Apm205a | Medwave, Inc. | DXN | Class II | |
| K011104 | Osteobell | Biopsybell S.A.S. | KNW | Class II | |
| K010961 | X-Tenda Cuff Powder Free Non-Sterile Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less) | Ansell Healthcare Products LLC | LYY | Class I | |
| K010898 | Ultracision Harmonic Scalpel Blades, Model Dh105,dh145,sh105, Sh145,hc145 | Ethicon Endo-Surgery Inc | LFL | Unclassified | |
| K010865 | Amsco Century Medium Sterilizer, Model Century | STERIS Corporation | FLE | Class II | |
| K010800 | Versyo.com | Kulzer GmbH | EBI | Class II | |
| K010632 | Butterfly Plate Function System | Medtronic Sofamor Danek USA Inc | KWP | Class II | |
| K003871 | Laparoscopic Hand Port | Applied Medical Resources Corp | GCJ | Class II | |
| K003761 | Nat - Nucleic Acid Transport | Medical Packaging Corporation | LIO | Class I | |
| K002847 | Introducer with Distal Radiopaque Marker Band, Model or-4926Xx | Maxxim Medical | DYB | Class II | |
| K002514 | Cadhealth System, Model Chp-001 | Caduceus Health Care, Ltd. | DRG | Class II | |
| K001442 | Esu Handswitching Pencil | Surgex, Inc. | GEI | Class II | |
| K011415 | Alpco Milenia Anti-Tg Eia | American Laboratory Products Company | JZO | Class II |