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 |
|---|---|---|---|---|---|
| K881887 | Sharplan 719Y Microslad(tm) | Sharplan Lasers, Inc. | GEX | Class II | |
| K881879 | Ats M/15 Phosphate Buffer, Product #034-42 | Alpha-Tec Systems, Inc. | JSK | Class I | |
| K881738 | Audiotone Model Tlc Secret in-the-Ear Hearing Aid | Audiotone, Inc. | ESD | Class I | |
| K881737 | Audiotone Model Avatar in-the-Ear Hearing Aid | Audiotone, Inc. | ESD | Class I | |
| K881730 | Breast Localization Needles | Hart Enterprises, Inc. | GDM | Class I | |
| K881698 | Ats Pva Fixative Solution | Alpha-Tec Systems, Inc. | LDZ | Class I | |
| K881669 | Mvr/stiletto Blade 20Ga. - P/n 1900 | Advanced Surgical Products, Inc. | HNN | Class I | |
| K881653 | Audiotone Model Asp Secret in-the-Ear Hearing Aid | Audiotone, Inc. | ESD | Class I | |
| K881592 | Wescor Model 7300 Aerospray Gram Stainer | ELITechGroup Inc | KPA | Class I | |
| K881369 | Advance Diagnostics Disposable Eyecup | Advantage Diagnostics Corp. | LXQ | Unclassified | |
| K881186 | Microhematocrit Tubes, Heparin & Microhema Tube,pl | Helps Products, Inc. | GHY | Class II | |
| K881180 | Fitc Murine Monoclonal Anti-Herpes Type 1 Igg | Whittaker Bioproducts, Inc. | GQN | Class II | |
| K881046 | Super Pik Massaging Pick for Oral Hygiene | U.S. Dentek Corp. | JET | Class I | |
| K881011 | Bivona Ultra Low Resistance Voice Prosthesis | Bivona Medical Technologies | EWL | Class II | |
| K881001 | Mentor Wet-Field*ii Coagulator | Mentor O & O, Inc. | HQQ | Class II | |
| K880996 | Fitc Murine Monoclonal Anti-Hsv Bivalent Igg | Whittaker Bioproducts, Inc. | GQN | Class II | |
| K880989 | Ats Cryptosporidium Stain Set | Alpha-Tec Systems, Inc. | JTS | Class I | |
| K880987 | Injector Handle with Syringe | Applied Vascular Devices, Inc. | DXT | Class II | |
| K880953 | Advanced Surgical 19 & 20 Gauge Disp. Scleral Plug | Advanced Surgical Products, Inc. | LXP | Class II | |
| K880952 | Prisma Disposable 19 and 20 Gauge Scleral Plugs | Advanced Surgical Products, Inc. | LXP | Class II | |
| K880938 | Ite Type Hearing Aid ABS Model | A Better Sound Corp. | ESD | Class I | |
| K880641 | Sensititre Stability Plates | Sensititre, Ltd. | JWY | Class II | |
| K880615 | Ambulatory ECG Digital Monitor Model: Td-30 | Cardiotechnics, Inc. | DXH | Class II | |
| K880533 | Vitel III Cm | Equimed Corp. | DXH | Class II | |
| K880498 | Rm-301 Patient Monitor | Ppg Industries, Inc. | DRT | Class II | |
| K875361 | Serodot Cmv (Cytomegalovirus) Igg Test Kit | Disease Detection International, Inc. | LFZ | Class II | |
| K875138 | Trichomate(r) Super | Mercia Diagnostics, Ltd. | JWZ | Class I | |
| K874921 | Headfirst (Condom) | Stual Products, Inc. | HIS | Class II | |
| K874839 | Stat-Sat | Gish Biomedical, Inc. | DRY | Class II | |
| K874482 | Revised Immudia Hem-Sp | Schiff & Co. | KHE | Class II | |
| K873565 | Snap(r) Rotavirus Diagnostic Kit | Molecular Biosystems, Inc. | LIO | Class I | |
| K872881 | Abbott Cmv-M Eia Kit | Abbott Medical | LKQ | Class II | |
| K872541 | Ortho Monolert* Rapid Elisa Test for Infect. Mono. | Ortho Diagnostic Systems, Inc. | LJN | Class I | |
| K881004 | Olympus-Keymed Endoscopic CO2 Regulator, Model Ecr | Keymed, Inc. | FCX | Class II | |
| K880780 | Heartstart 2000 Defibrillator Tester, ECG | First Medical Devices Corp. | DRL | Class II | |
| K880754 | Dri-Clave Liquid Kleenzall | Columbus Dental Mfg. Co. | EHZ | Class I | |
| K880300 | Cardiobeeper(r) III | Survival Technology, Inc. | DXH | Class II | |
| K881848 | Modified Model 2100 Nd:yag Laser | Sharplan Lasers, Inc. | GEX | Class II | |
| K881745 | Infuse-a-Port Radiopaque Polyurethane Catheter | Shiley Infusaid, Inc. | LJT | Class II | |
| K881652 | Audiotone Model a-61 Behind-the-Ear Hearing Aid | Audiotone, Inc. | ESD | Class I | |
| K881345 | Imx Ferritin | Abbott Medical | DGD | Class II | |
| K881236 | Toray Anthron P-U Catheters | Toray Industries (America), Inc. | FOZ | Class II | |
| K881211 | Tru-Tech 310 Ultrasound Therapy Unit #310 | Tru-Trac Therapy Products, Inc. | IMI | Class II | |
| K880993 | Amalgamator | Acecodent, Inc. | EFD | Class I | |
| K880956 | Snoar(tm) Open Airway Appliance | Kent J. Toone, D.D.S. | LQZ | Class II | |
| K880916 | M444 EMG Monitor | Bio-Logic Devices | HCC | Class II | |
| K880914 | T824 Temperature Monitor | Bio-Logic Devices | HCC | Class II | |
| K880913 | M424 EMG Monitor | Bio-Logic Devices | HCC | Class II | |
| K880890 | The S.a.f.e. System | Pfizer Laser Systems | FYD | Class II | |
| K880849 | Examix Dispenser | G-C Intl. Corp. | EKJ | Class I |