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 |
|---|---|---|---|---|---|
| K892241 | Fetal Hemoglobin | Sure-Tech Diagnostic Associates, Inc. | GHQ | Class II | |
| K890992 | Woodlyn Ophthalmic Projector | Woodlyn, Inc. | HOS | Class I | |
| K890714 | Lacrimal Efficiency Test (Tm) | Lacrimedics, Inc. | LZU | Unclassified | |
| K885230 | Mcdonald Folding Forceps | Alcon Laboratories | HNR | Class I | |
| K892901 | Aca Vancomycin Calibrator | E.I. Dupont de Nemours & Co., Inc. | DLJ | Class II | |
| K892650 | Tdx Barbiturates Serum | Abbott Medical | DIS | Class II | |
| K891761 | Gds Enzymatic Theophylline Reagent | Gds Diagnostics | LCY | Class II | |
| K891482 | Aml(r) Collarless Lateralized Femoral Hip | Depuy, Inc. | KWL | Class II | |
| K891386 | Cvis Ultra-Scan One Imaging System | Cardiovascular Imaging Systems, Inc. | IYO | Class II | |
| K891309 | 5.0 Mhz Array Intravaginal Transducer | Advanced Technology Laboratories, Inc. | IYO | Class II | |
| K891009 | Intravascular Administration Set Model 60040 | 3M Company | FPK | Class II | |
| K890969 | Transesophageal Transducer Pef-511Sa | Toshiba Medical Systems | IYO | Class II | |
| K890919 | Temporary Intracanalicular Collagen Implant | Grace Medical, Inc. | LZU | Unclassified | |
| K890783 | Grieshaber Viscoelastic Injection System | Grieshaber & Co. | FRN | Class II | |
| K890588 | Gentle Expressions Electric Breast Pump | Healthteam | HGX | Class II | |
| K890407 | The Saxon Spermicidal Condom W/2 Year Expiration | Circle Rubber Corp. | HIS | Class II | |
| K890055 | Acuson S228 Transducer for Transcranial Doppler | Acuson Corp. | IYN | Class II | |
| K885231 | Kitchin Dental Abcess Drain | Kitchin, Inc. | EIE | Class I | |
| K884266 | Ph Blood Gas Control Products | Alko Diagnostic Corp. | JPK | Class II | |
| K884151 | Model G7731d Washer/disinfector for Dental Instru. | Miele Appliances, Inc. | LDS | Class II | |
| K883840 | Dri-Vent Arterial Blood Sampling Kit | Concord Laboratories, Inc. | LKB | Unclassified | |
| K892887 | St Series Saf-T-Shunts Arteriovenous Cannula | Akcess Medical Products, Inc. | FIQ | Class II | |
| K892502 | Electrosurgical Pencil | Yuntek International, Inc. | GEI | Class II | |
| K892451 | Safe-T-Face Disposable Face Shield | Barry S. Smith Co. | FXX | Class II | |
| K891903 | Cohn Targeteer | Mizuho Orthopedic Systems Inc | LXH | Class I | |
| K890962 | Orthopaedic Staples | Ortho Spectrum, Inc. | JDR | Class II | |
| K890922 | Accu-Beam Yag Fiber | Tti Medical | GEX | Class II | |
| K890642 | Vzv Microassay | Diamedix Corp. | LFY | Class II | |
| K885348 | A-V(tm) Softouch Uhf Cardiac Pigtail | Mallinckroot, Inc. | DQO | Class II | |
| K884628 | Harborin Central Venous Catheter | Harbor Medical Devices, Inc. | DQR | Class II | |
| K892679 | Patient Examination Gloves (Latex) | Mastervest Corp. Sdn Bhd. | LYY | Class I | |
| K892677 | Patient Examination Gloves (Latex) | Ultrajaya Sdn. Bhd. | LYY | Class I | |
| K892512 | Patient Examination Gloves (Latex) | Sar King Ent. Co., Ltd. | LYY | Class I | |
| K892511 | Patient Examination Gloves (Latex) | Ampac Rubber Co., Ltd. | LYY | Class I | |
| K892510 | Patient Examination Gloves (Latex) | Yung Chieh Ent. Co., Ltd. | LYY | Class I | |
| K892242 | Patient Examination Gloves (Latex) | Apothecary Products, LLC | LYY | Class I | |
| K892110 | Protector Patient Examination Gloves (Latex) | Brajatama, Inc. | LYY | Class I | |
| K892012 | Patient Examination Glove (Latex) | Glorious Wealth Co., Ltd. | LYY | Class I | |
| K891975 | Patient Examination Gloves (Latex) | Ever Surplus (USA), Inc. | LYY | Class I | |
| K891974 | Patient Examination Gloves (Latex) | The Foreign Trade Co. of Zhangjiagong | LYY | Class I | |
| K891973 | Patient Examination Gloves (Latex) | Victorison 1988, Ltd. | LYY | Class I | |
| K891972 | Patient Examination Gloves (Latex) | Grandtech Rubber Products Co., Ltd. | LYY | Class I | |
| K891971 | Patient Examination Gloves (Latex) | Zhuhai Gold Class, Ltd. | LYY | Class I | |
| K891962 | Prolife Patient Examination Gloves (Latex) | Firestone Financial Corp. | LYY | Class I | |
| K891945 | Patient Examination Gloves (Vinyl) | Libent Co., Ltd. | LYZ | Class I | |
| K891934 | Addwealth Latex Examination Gloves | Precision Trading Intl., Inc. | LYY | Class I | |
| K891848 | Vinyl Exam Gloves, C&k Style #1025Fs | C & K Mfg. & Sales Co. | LYZ | Class I | |
| K891836 | Bud Brand Patient Examination Gloves (Latex) | Associated Ent., Inc. | LYY | Class I | |
| K891805 | Hygeia Examination Gloves | Hygeia, Ltd. | LYY | Class I | |
| K891748 | Almatex Patient Examination Gloves (Latex) | Healthgard Medical Products Ltd. Partnership | LYY | Class I |