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 |
|---|---|---|---|---|---|
| K951824 | Storz Microseal Phacoemulsification Needles (Importation) | Nidek, Inc. | HQC | Class II | |
| K951532 | Metal Ureteral Basket Stone Dislodger | Annex Medical, Inc. | FFL | Class II | |
| K951239 | Glowing Spirits | Ormco Corp. | DYW | Class II | |
| K950354 | Human Chorionic Gonadotropin (Hcg) Test System for the Early Detection of Pregnancy | Ml Strategies, Inc. | LCX | Class II | |
| K946046 | Deroyal Technologices, Inc. Liquid Crystal Skin Temperature Strip | Deroyal Critical Care, Div. Deroyal Technologies | FQZ | Class I | |
| K945815 | Dental Kit | Constancy Ent., Inc. | EKJ | Class I | |
| K945443 | Bobes Lens Set | Bobes S.A. | HPC | Class I | |
| K944788 | Intact Pth Immunoradiometric (Irma) Assay (Coated Bead-Technology) | Scantibodies Laboratory Inc. | CEW | Class II | |
| K944543 | Bioflex Garments, Assorted Models | Bioflex, Inc. | GXY | Class II | |
| K943010 | Maxilube | Mission Pharmacal Company | KMJ | Class I | |
| K942922 | Selecta 20/60 Chemistry Analyzer | Select Medical Systems, Inc. | JJE | Class I | |
| K952145 | Sas Febrile Positive & Negative Control Antiserum | SA Scientific, Ltd | GSN | Class II | |
| K952139 | Sas Brucella Suis Antigen | SA Scientific, Ltd | GSO | Class II | |
| K952082 | Rochester Medical Corporation Silicone Male External Catheter | Rochester Medical Corp. | EXJ | Class I | |
| K952055 | Orgen Tec Anti-Dsdna Pin Immuno Assay | American Laboratory Products Company | LRM | Class II | |
| K952031 | Ultrasound Transducer, Model Us917 | Advanced Medical Systems, Inc. | HGL | Class II | |
| K951897 | Power Resectoscope Cutting Loop | Power Analytics Corp. | FAS | Class II | |
| K951850 | Enzyme Immunoassay Anti-Jo-1 Antibody Test Kit | Helix Diagnostics, Inc. | LJM | Class II | |
| K951656 | Nexmed Cancellous Bone Screws | Nexmed, Inc. | HWC | Class II | |
| K950441 | Conair Family Fitness Body Energy | Conair LLC. | IRO | Class I | |
| K946385 | Quanta Lite Aca Igm (Hrp) | Inova Diagnostics, Inc. | MID | Class II | |
| K946333 | Ibi-1000(Tm) Electrophysiology Cathter | Irvine Biomedical. Inc. | DRF | Class II | |
| K946034 | Quanta Lite(tm) Igg (Hrp) | Inova Diagnostics, Inc. | MID | Class II | |
| K944159 | Hm-Cap Eia Kit | Schiff & Co. | LYR | Class I | |
| K941418 | Infusion Pump | Halyard Health | MEB | Class II | |
| K934857 | Hss Femoral Components | Hospital for Special Surgery | JDI | Class II | |
| K934458 | Dried Gram-Positive Mic/combo Panels | Baxter Diagnostics, Inc. | JWY | Class II | |
| K952977 | Sabre Multi-Use Trocar System | Endoscopic Concepts, Inc. | GCJ | Class II | |
| K952772 | Megabeam Endo-ENT Probe | Ceram Optec, Inc. | GEX | Class II | |
| K952594 | N Protein Standard Sy | Behring Diagnostics, Inc. | CZW | Class II | |
| K952593 | N/t Protein Control Sy/l, M and H | Behring Diagnostics, Inc. | DAD | Class II | |
| K952587 | Endocare Monopolar Electrodes | Cytocare, Inc. | GEI | Class II | |
| K952463 | Gs & Gs20 Surgical Tool System | Midas Rex Pneumatic Tools, Inc. | GET | Class I | |
| K952350 | Jamshidi Style Biopsy Needle (Acri) (Biomid), Illinois Style Biopsy Needle (Isan) | Promedical, Ltd. | LWE | Class II | |
| K952299 | Surgiscan Scanner | Norcross Scientific | GEX | Class II | |
| K952297 | Foundation Textured Stem | Encore Orthopedics, Inc. | LWJ | Class II | |
| K952283 | Amerlite Hcg-60 Assay | Johnson & Johnson Clinical Diagnostics, Inc. | DHA | Class II | |
| K952281 | Active Free Testosterone Ria | Diagnostic Systems Laboratories, Inc. | CDZ | Class I | |
| K952250 | Stratus Ck-Mb Dendrimer Fluorometric Enzyme Immunoassay & Stratus Ck-Mb Dendrimer High Sample Diluent | Dade Intl., Inc. | JHS | Class II | |
| K952199 | Active Intact Pth Elisa | Diagnostic Systems Laboratories, Inc. | CEW | Class II | |
| K952191 | Forged Cemented Stem | Encore Orthopedics, Inc. | JDI | Class II | |
| K952147 | Sas Brucella Abortus Antigen | SA Scientific, Ltd | GSO | Class II | |
| K952142 | Sas Salmonella O Group D Antigen | SA Scientific, Ltd | GNC | Class II | |
| K952140 | Sas Brucella Meltiensis Antigen | SA Scientific, Ltd | GSO | Class II | |
| K952138 | Sas Francisella Tularensis Antigen | SA Scientific, Ltd | GSL | Class II | |
| K952137 | Sas Salmonella H a Antigen | SA Scientific, Ltd | GSO | Class II | |
| K952136 | Sas Salmonella H B Antigen | SA Scientific, Ltd | GSO | Class II | |
| K952135 | Sas Salmonella H D Antigen | SA Scientific, Ltd | GSO | Class II | |
| K952131 | Sas Febrile Antigen Set | SA Scientific, Ltd | GSO | Class II | |
| K951979 | Sunglasses | Heyro Optical Manufactory | HQY | Class I |