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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K890618 | Coomassie Blue Total Protein Assay Kit | Kenlor Industries, Inc. | CEK | Class II | |
| K890592 | Patient Examination Glove | Alfaseal Sdn. Bhd. | LYY | Class I | |
| K881383 | Nd1100 Bone Density Scanner | Nuclear Data, Inc. | KGI | Class II | |
| K893011 | Argipal | Argen Precious Metals, Inc. | EJT | Class II | |
| K893009 | Argelite Sr+ | Argen Precious Metals, Inc. | EJT | Class II | |
| K893008 | Argelite 54 | Argen Precious Metals, Inc. | EJT | Class II | |
| K892908 | Argelite 80Sf Dental Alloy | Argen Precious Metals, Inc. | EJT | Class II | |
| K892816 | Argedent 38 | Argen Precious Metals, Inc. | EJT | Class II | |
| K892815 | Argedent 45Sf | Argen Precious Metals, Inc. | EJT | Class II | |
| K892813 | Argelite 60 | Argen Precious Metals, Inc. | EJT | Class II | |
| K892812 | Argelite 75+6 | Argen Precious Metals, Inc. | EJT | Class II | |
| K892708 | Argedent Y-86 Dental Alloy | Argen Precious Metals, Inc. | EJT | Class II | |
| K892431 | Kendall Curity Feeding Tubes | The Kendal Co. | FPD | Class II | |
| K892336 | Behind-the-Ear Hearing Aid Model 48 Pp Pc | Qualitone | ESD | Class I | |
| K892333 | Rexton Rx12pp, Rx20pp & Rx34pp in-the-Ear Hear Aid | Rexton, Inc. | ESD | Class I | |
| K892211 | Heraeus Lasersonic Inc. Sterile Disposable Fibers | Heraeus Lasersonics, Inc. | GEX | Class II | |
| K891463 | Adherence M5 Multi-Cure Composite Cement System | Confi-Dental Products Co. | EBF | Class II | |
| K891320 | Argelite 58P (Dental Alloy) | Argen Precious Metals, Inc. | EJT | Class II | |
| K891230 | Maxima* Hollow Fiber Oxygenator W/filtered Reserv. | Medtronic Blood Systems, Inc. | DTZ | Class II | |
| K891022 | Introducer for Ptca Guiding Catheters | Argon Medical Corp. | DYB | Class II | |
| K891000 | Modified External Pad | Instromedix, Inc. | DWS | Class I | |
| K890938 | Kendall Scd Therapeutic System | Kendall Healthcare Products Co. Div.Of Tyco Health | JOW | Class II | |
| K890525 | Interton Bte Hear Aid, Supra, Suprema, Minetta | Magnatone Hearing Aid Corp. | ESD | Class I | |
| K890445 | Personal Alert Assist Device | Silent Call Corp. | LXI | Class I | |
| K890209 | Disposable Angiography Needles | E-Z-EM, Inc | DRC | Class II | |
| K890208 | High Pressure Connecting Sets | E-Z-EM, Inc | DXT | Class II | |
| K890206 | E-Z-Flow Angiography Catheters | E-Z-EM, Inc | DQO | Class II | |
| K884804 | The Coach | Promark, Inc. | DRT | Class II | |
| K884405 | Fortec Mi-150 Digital Blood Pressure Meter | Nam Tai Electronic & Electrical Products, Ltd. | DXN | Class II | |
| K892872 | Peritoneal Dialysis Cycler Set W/12 Prong Manifold | National Medical Care, Medical Products Div., Inc. | KDJ | Class II | |
| K892871 | Peritoneal Dialysis Cycler Set, W/8 Prong Manifold | National Medical Care, Medical Products Div., Inc. | KDJ | Class II | |
| K892870 | Peritoneal Dialysis Cycler Set, W/5 Prong Manifold | National Medical Care, Medical Products Div., Inc. | KDJ | Class II | |
| K892549 | Suction Tubes: House, Baron | Zinnanti Surgical Instruments, Inc. | GCX | Class II | |
| K892375 | Modified Am-Series Dialyzers | Asahi Kasei Medical MT Corp. Oita Works | FJI | Class II | |
| K892374 | New Am-Series Dialyzers | Asahi Kasei Medical MT Corp. Oita Works | FJI | Class II | |
| K892239 | Dental Hand Instruments | Implant Support Systems, Inc. | EKJ | Class I | |
| K892234 | Argedent 75 | Argen Precious Metals, Inc. | EJT | Class II | |
| K892221 | Pulmonary Resuscitator, Modification | Life Design Systems, Inc. | BTM | Class II | |
| K892113 | Q5000 Pc Workstation | Quinton, Inc. | DQK | Class II | |
| K891931 | Qct-Lung Nodule (Tm) Analysis Package | Image Analysis, Inc. | JAK | Class II | |
| K891924 | Scopix Laser Imager | Enhanced Imaging Technologies, Inc. | LMC | Class II | |
| K891464 | Resilience C2, Resilience L3 & Resilience P4 | Confi-Dental Products Co. | DYH | Class II | |
| K891455 | Dentin Primer | Dentsply Intl. | KLE | Class II | |
| K891176 | Injection Site Plug (Intravascular Administration) | Multi-Med, Inc. | FPA | Class II | |
| K890274 | Mem-7102; Meb-7102 Evoked Response & Electro Recor | Nihon Kohden America Inc | GWF | Class II | |
| K884739 | Sgarlato Lesser Toe Implant | Sgarlato Laboratories, Inc. | KWH | Class II | |
| K884732 | Superior Endosseous Dental Implant System | Bio-Interfaces, Inc. | DZE | Class II | |
| K884396 | Modified Ther-a-Pulse Unit | Westec Corp. | IPF | Class II | |
| K892911 | Site Peristaltic Cassette | Site Microsurgical Systems, Inc. | HQC | Class II | |
| K892897 | Nova Gel(tm) Jo-1 | Inova Diagnostics, Inc. | LLL | Class II |