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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K861333 | Ultra-Violet Gogglets | Health Saver Products | |||
| K861284 | Ap Reagent Cartridge | Hi Chem, Inc. | CJE | Class II | |
| K861283 | Ast Reagent Cartridge | Hi Chem, Inc. | CIT | Class II | |
| K861231 | Alt Reagent Cartridge (Product No. 88210) | Hi Chem, Inc. | CKA | Class I | |
| K861203 | Multi-Spike | Surgeon Surgical Instrumentation, Inc. | KYG | Class I | |
| K861104 | Variable High Flow Downs CPAP Generator | Med Air Technology, Inc. | BYE | Class II | |
| K861025 | T-Vac Pleural Drainage Unit, 7800 Series | Boehringer Laboratories, LLC | KDQ | Class II | |
| K860900 | Immpulse Free Estriol Assay Reagents | Sclavo, Inc. | CGI | Class I | |
| K860841 | Guide Wire Introducer | Target Therapeutics | DQX | Class II | |
| K860824 | Tshk-Nn Ria Kit | Cis-Us, Inc. | JLW | Class II | |
| K860287 | Pulsonic Digital Blood Pressure Monitor Model Bp-3 | Healthcheck Corp. | DXN | Class II | |
| K854370 | Mpv-7201 Non-Invasive Blood Pressure Monitor | Nihon Kohden America Inc | DXN | Class II | |
| K853401 | Chlamyset Antigen | Orion Corp. | LJP | Class I | |
| K861405 | Replacement Hoses | Micro-Aire Surgical Instruments, Inc. | HSZ | Class I | |
| K861336 | Iap Plate Test | Scientific Sales Intl., Inc. | LKL | Class I | |
| K861230 | Monitral S | Hospal Medical Corp. | FKP | Class II | |
| K861184 | Phadebas Rast/phadezym Rast Test Allergen Discs | Pharmacia, Inc. | DHB | Class II | |
| K861171 | Quidel Allergy Screen | Ortho-Clinical Diagnostics, Inc. | DGC | Class II | |
| K861167 | Immunoglobulins A,g,m,d,e Immunological Test | Atlantic Antibodies | CZP | Class II | |
| K861107 | Tan Mate Home Tanning Unit | Specialty Engineering, Inc. | FTC | Class II | |
| K861005 | Glasionomer Base Cement | Shofu Dental Corp. | EMA | Class II | |
| K860993 | P.o. Vox | Bloomfield Research and Development, Inc. | ESE | Class I | |
| K860982 | Db Precision Implant System, 2000 Series | Driskell Bioengineering | DZE | Class II | |
| K861413 | Bilirubin*sr (Total) Liquid Stable Reagent Set | Medical Analysis Systems, Inc. | CIG | Class II | |
| K861328 | New Belmont Model, Mc-5 Dental, Intraoral X-Ray | Belmont Equipment Corp. | EAP | Class II | |
| K861320 | Mms T4 Ria Kit | Micromedic Systems | CDX | Class II | |
| K861311 | Glucose (Hexokinase) Reagent Set | Sterling Diagnostics, Inc. | CFR | Class II | |
| K861221 | Easy-Test Chek (Instrum. Check) & Emds ABS Test | Em Diagnostic Systems, Inc. | JJX | Class I | |
| K861204 | Glucose Oxidase Procedure | Data Medical Associates, Inc. | CGA | Class II | |
| K861194 | Ultrospec K Kinetics Spectrophotometer | Lkb Instruments, Inc. | JJQ | Class I | |
| K861168 | Clearblue Pregnancy Testing Kit | Unipath, Ltd. | LCX | Class II | |
| K861141 | Manual Ophthalmic Surgical Instruments | CooperVision, Inc. | HNR | Class I | |
| K861061 | Emds Creatine Kinase Isoenzyme Ckmb Test Pack | Em Diagnostic Systems, Inc. | CGS | Class II | |
| K861057 | Manual Ophthalmic Surgical Instruments | Precision-Cosmet Co., Inc. | HNR | Class I | |
| K861055 | Easy-Test Ise Calibrator, Item No. 67566/95 | Em Diagnostic Systems, Inc. | JJE | Class I | |
| K860965 | Beta Quik Stick | Pacific Biotech, Inc. | JHI | Class II | |
| K860733 | Ck-Nac Reagent Creatine Kinase N-Acetyl Cysteine | Trace Scientific, Ltd. | CGS | Class II | |
| K860716 | Enzymatic Bun Reagent | Trace Scientific, Ltd. | CDQ | Class II | |
| K860715 | Alp (Alkaline Phosphatase) Reagent | Trace Scientific, Ltd. | CJE | Class II | |
| K860713 | Lactate Dehydrogenase (Ld) for Cont. Flow Instrum. | Catachem, Inc. | CFJ | Class II | |
| K860350 | Serum Cholinesterase Reagent Set | Sterling Diagnostics, Inc. | DLI | Class I | |
| K860335 | Coat-a-Count 17-Alpha-Hydroxyprogesterone Ria Kit | Siemens Healthcare Diagnostics Inc. | JLX | Class I | |
| K860205 | Bio-Pen Calculator | Oculab, Inc. | LQB | Class III | |
| K860087 | Sharplan Model 1020 CO2 Surgical Laser System | Sharplan Lasers, Inc. | GEX | Class II | |
| K854821 | Mmg External Female Catheters | Medical Technologies of Georgia | KNX | Class II | |
| K854207 | Ebv(epstein-Barr Virus) Test Kit | Immuno-Diagnostic Products, Inc. | GNP | Class I | |
| K852622 | Aerosol One | Ashai Co., Ltd. | BTI | Class II | |
| K861357 | Whenever Unscented Panty Shield | Marcal Paper Mills, Inc. | HHD | Class I | |
| K861356 | Whenever Unscented Super Thin Maxi-Pads | Marcal Paper Mills, Inc. | HHD | Class I | |
| K861355 | Whenever Unscented Regular Thin Maxi-Pads | Marcal Paper Mills, Inc. | HHD | Class I |