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 |
|---|---|---|---|---|---|
| K960493 | Syphilis Igg Human Serum Controls | Pyramid Biological Corp. | LIP | Class II | |
| K960167 | System, Thermal Regulating 74-Dwj | Augustine Medical, Inc. | DWJ | Class II | |
| K960092 | Seraquest Toxoplasma Igg | Quest Intl., Inc. | LGD | Class II | |
| K955342 | Omron, Lumiscope, Labtron, Medi - Source, Baxter | Rashman Corp. | DXN | Class II | |
| K954302 | Vygon Premi-Cath - Long Term Catheter | Vygon Corp. | LJS | Class II | |
| K950838 | Virazyme Culture Confirmation Screen for Influenza and Parainfluenza Viruses | Zymetx, Inc. | GNT | Class I | |
| K950672 | Immulite Cmv Igg | Siemens Healthcare Diagnostics Inc. | LFZ | Class II | |
| K962030 | Karl Storz Remorgida Forceps | Karl Storz Endoscopy-America, Inc. | GEI | Class II | |
| K961890 | Foundation 9Mm Forged Cemented Stem | Encore Orthopedics, Inc. | JDI | Class II | |
| K961481 | Elecsys 2010 Analyzer | Boehringer Mannheim Corp. | JJE | Class I | |
| K961435 | Mouse Anti-Human Cd2, T-Cell/fitc and Mouse Anti-Human Cd19, B-Cell/rpe | Dako Corp. | GKZ | Class II | |
| K961355 | Multicheck | Radiometer America, Inc | JJS | Class I | |
| K961354 | Qualicheck 4 Metabolite(s3630,s3640,s3650,s3660) | Radiometer America, Inc | JJS | Class I | |
| K961159 | Powered Low Air Loss Mattress System | Span-America Medical Systems, Inc. | FNM | Class II | |
| K961137 | Ati Plasma Pump (Pp-04) | Apheresis Technologies, Inc. | FIR | Class II | |
| K961092 | Visart | Toshiba America Medical Systems, In.C | LNH | Class II | |
| K961078 | Automated Vitrectomy Device | Promex, Inc. | HQE | Class II | |
| K960934 | Hp M1205a Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | MLD | Class II | |
| K960874 | Complement Control | FUJIFILM Healthcare Americas Corporation | JJX | Class I | |
| K960637 | 5Mm Endoscope | Origin Medsystems, Inc. | GCJ | Class II | |
| K960531 | Mouse Anti-Human Cd3, T-Cell/fitc & Cd19, B-Cell/rpe | Dako Corp. | GKZ | Class II | |
| K955662 | Candela Q-Switched Alexandrite Lasers | Candela Corporation | GEX | Class II | |
| K953662 | First Choice Ketones Urine Test Strips | Polymer Technology Intl. | JIN | Class I | |
| K953661 | First Choice Glucose Urine Test Strips | Polymer Technology Intl. | JIL | Class II | |
| K961812 | Electrosurgical and Arthroscopy Accessory Electrodes | Conmedcorp | GEI | Class II | |
| K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | FTM | Class II | |
| K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | FTM | Class II | |
| K961759 | Cement and Bone Removal Kit | Maillefer Instruments S.A. | HWE | Class I | |
| K961662 | Advanced Care Hydrophilic Wound Dressings | Mariner Biomedical, Inc. | KMF | Class I | |
| K961659 | Cedia Core Tdm Multi-Cal | Boehringer Mannheim Corp. | JIX | Class II | |
| K961620 | Abiscreen Online for Cannabinoids - Es 50/100 | Roche Diagnostic Systems, Inc. | LAT | Class II | |
| K961490 | Elecsys T4 Assay | Boehringer Mannheim Corp. | CDX | Class II | |
| K961406 | Neuroview Scissors | Neuro Navigational Corp. | GWG | Class II | |
| K961213 | Alta Dome and Plunger (Mec Hip Bolt) | Howmedica Corp. | KTT | Class II | |
| K960762 | Synergy Plus | The Prometheus Group | HCC | Class II | |
| K960591 | Re-Usable Bipolar Concentric Needle(237-Xxx-24,237-Xxx-24Stp, 237-Xxx-24Tp,237-Xxx-24Stp | Chalgren Enterprises, Inc. | IKT | Class II | |
| K955423 | Pack H Hemodialysis Urea Kinetic Modeling Software Program | Fresenius USA, Inc. | FKP | Class II | |
| K955087 | Hemoglobin Alc (Hba1c) & Total Assays for the Technicon Ra/opera Systems in-Vitro Diagnostic Systems | Bayer Corp. | LCP | Class II | |
| K953697 | The Ims Dpap Mask, Ims Model Number 82000 | SleepNet Corporation | BZD | Class II | |
| K953411 | Breath-Taker Breath-Alert | Roxon - Universal Medical, Ltd. | BZH | Class II | |
| K942032 | Plamp, Plamp Plate, Plamp with Hook | Hospital for Special Surgery | HRS | Class II | |
| K933722 | Horizon Diagnostics Triglycerides-Gpo Reagent | Horizon Diagnostics, Inc. | CDT | Class I | |
| K961515 | Quantase Phenylalanine Assay | Shield Diagnostics, Ltd. | JNB | Class II | |
| K961488 | Elecsys T-Uptake Assay | Boehringer Mannheim Corp. | KHQ | Class II | |
| K961487 | Elecsys Hcg Assay | Boehringer Mannheim Corp. | DHA | Class II | |
| K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | JFP | Class II | |
| K961409 | Porta'pure/dental | Water Solution Technologies | EIA | Class I | |
| K961393 | Tricyclics Serum Tox Assay | Diagnostic Reagents, Inc. | LFH | Class II | |
| K961325 | Accusign Doa 3/Doa 3 (Bzo/bar/pcp), Bzo/bar/pcp, Biosign Doa 3/Bzo/bar/pcp, Biosign Bzo/bar/pcp | Princeton BioMeditech Corp. | JXM | Class II | |
| K961212 | Spinal Touch | Fasstech | KQX | Class I |