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 |
|---|---|---|---|---|---|
| K955895 | E. Histolytica Test | Techlab, Inc. | KHW | Class II | |
| K955586 | Robison & Smith Surgical Packs | Robison & Smith, Inc. | FYA | Class II | |
| K954607 | Reticulocyte Method | Bayer Corp. | GKL | Class II | |
| K953873 | Varelisa Helicobacter Pylori Antibodies | Elias U.S.A., Inc. | LYR | Class I | |
| K963240 | Immulite Acth Control Module (Laccm) | Siemens Healthcare Diagnostics Inc. | JJX | Class I | |
| K962975 | Prostate Specific Antigen (Rsa) Control Moddule (Psacm) | Siemens Healthcare Diagnostics Inc. | JJX | Class I | |
| K962782 | Freshfrozen Cells, Hep-2 | Ortho-Clinical Diagnostics, Inc. | KIR | Class I | |
| K962780 | Freshcells, Hep-2 | Ortho-Clinical Diagnostics, Inc. | KIR | Class I | |
| K962580 | Ez Sure Onestep Early Pregnancy Test | Excel Scientific, Inc. | LCX | Class II | |
| K962405 | Sanicure Disposable Curing Probe | Efos Canada, Inc. | EBF | Class II | |
| K962371 | Dermtome Blade | Dsp Worldwide | GFD | Class I | |
| K962311 | Freshfrozencells | Ortho-Clinical Diagnostics, Inc. | KIR | Class I | |
| K962306 | Fresh Cells Multi-Well & Shell Vial Cultures | Ortho-Clinical Diagnostics, Inc. | KIR | Class I | |
| K962289 | Select Shoulder Cocr Humeral Stem Component | Intermedics Orthopedics | HSD | Class II | |
| K962259 | Libbe Rectal Tube (Formerly a Yankauer Suction Tube) | Tiller Mind Body, Inc. | KPL | Class II | |
| K962248 | P.f.c. Ceramic Hip Head | Johnson & Johnson Professionals, Inc. | LZO | Class II | |
| K962135 | D.o.r.c. Microdiathermy System | Dutch Ophthalmic USA, Inc. | HQO | Class II | |
| K962115 | Cambridge Heart Hi-Res ECG Electrode | Cambridge Heart, Inc. | DRX | Class II | |
| K962106 | Spline Dental Implant Systems | Calcitek, Inc. | DZE | Class II | |
| K962097 | Ventricular Catheter Set | Cook Inc. | JXG | Class II | |
| K961860 | A4907 Lens Cleaning Sheath | OLYMPUS Corporation of the Americas | HET | Class II | |
| K961702 | Ksea Vaporization Electrodes | Karl Storz Endoskop GmbH | FAS | Class II | |
| K960549 | Mityvac Directional Vacuum Extractor, Disposable | Neward Enterprises, Inc. | HDB | Class II | |
| K960263 | Cervical Mucous Aspiration Catheter | Cook Incorporated | HFC | Class II | |
| K960003 | Storz D7116 Microvit Vitrectomy Cutter Extension | Storz Instrument Co. | HQC | Class II | |
| K955672 | Trojan Polyurethane Condom (Modification) | Carter Products | MOL | Class II | |
| K935512 | Corpak Replacement Gastrostomy Device Stomacore | Corpak Co. | KNT | Class II | |
| K962856 | Pleur-Evac Sahara Adult/pediatric Chest Drainage System Model S-1100, S-1200, 2-2100, and S-2200 with Model S-100 Autotr | Deknatel, Inc. | KDQ | Class II | |
| K962802 | Safe Mate i.v. Fluid Delivery Sets | Biological & Environmental Control Laboratories | FPA | Class II | |
| K962801 | Safe Mate i.v. Extension Sets | Biological & Environmental Control Laboratories | FPA | Class II | |
| K962581 | Stopcock Manifold Gangs | Baxter Healthcare Corporation | FMG | Class II | |
| K962553 | Ez-Fix Midshaft Humeral Intramedullary Rod System | Biodynamic Technologies, Inc. | HSB | Class II | |
| K962228 | Model Alpha Behind-the-Ear Hearing Instrument | Ototech Intl., Inc. | ESD | Class I | |
| K962224 | Select Shoulder Concentric Humeral Head Components | Intermedics Orthopedics | KWS | Class II | |
| K962193 | Portland Trocars | Surgical Innovations Ltd | GCJ | Class II | |
| K962156 | 3304 Pulse Oximeter | Bci Intl., Inc. | DQA | Class II | |
| K960971 | Oculight Gl | Iriderm Div. | HQF | Class II | |
| K960933 | Bio-Plexus Needle Disposal Container | Bio-Plexus, Inc. | FMI | Class II | |
| K960700 | Logiq A200 Diagnostic Ultrasound System | GE Healthcare | IYO | Class II | |
| K954623 | Redy 2000 System (Therapeutic Plasma Exchange Option and Monitoring Line Y-Connector) | Gambro Healthcare | FKT | Class II | |
| K951128 | Medilog Stresslink | Oxford Medical, Inc. | DPS | Class II | |
| K963178 | Elecsys Calcheck T4 | Boehringer Mannheim Corp. | JJX | Class I | |
| K963167 | Elecys Calcheck T 3 | Boehringer Mannheim Corp. | JJX | Class I | |
| K963164 | Elecsys Calcheck Ft4 | Boehringer Mannheim Corp. | JJX | Class I | |
| K963163 | Elecsys Calcheck Ft3 | Boehringer Mannheim Corp. | JJX | Class I | |
| K962934 | Airperm(siflufocon a) Rigid Gas Permeable Multifocal Contact Lenses for Daily Wear | Airperm, Inc. | HQD | Class II | |
| K962898 | Ksea Unimat Plus | Karl Storz Endoscopy-America, Inc. | EOB | Class II | |
| K962472 | Rusch Urodynamic Rectal Balloon 2-Way Catheter | Rusch Intl. | FAP | Class II | |
| K962397 | Statak Soft Tissue Attachment Device | Zimmer GmbH | MBI | Class II | |
| K962396 | Ksea Bipolar Goagulating Forceps | Karl Storz Endoscopy-America, Inc. | EOB | Class II |