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 |
|---|---|---|---|---|---|
| K884659 | Sarns 9000 with Centrifugal Pump Option | 3M Health Care, Sarns | KFM | Class II | |
| K884640 | Cardioplegia Overpressure Valve Cpop-350 & 700 | American Omni Medical, Inc. | KRI | Class I | |
| K884618 | Nova Celltrak 11 Auto. Hema. Analyzer, Calibrators | Nova Biomedical Corporation | GKL | Class II | |
| K884591 | Ebv-Vca Antibody (Igg) | Hillcrest Biologicals | GNP | Class I | |
| K884561 | Koenig Total Toe Implant | Dow Corning Wright | LZJ | Unclassified | |
| K884534 | Pall Hepchek (Tm) Heparin Absorption Filter | Pall Biomedical Products Co. | JPA | Class II | |
| K884340 | Amx-110, Amx-II and Amx-III | Dyna-Med | ILZ | Class I | |
| K884182 | Surgilase Yag 100 Surgiprobes & Surgiscalpel | Surgilase, Inc. | GEX | Class II | |
| K884169 | Du Pont Analyst Thyroid Rotor | The du Pont Co. | CEL | Class I | |
| K884090 | Lundy Vaporizer System | Vaporflow Technology, Inc. | CAD | Class II | |
| K884017 | Rotacube | Difco Laboratories, Inc. | LIQ | Class I | |
| K883898 | Magnetom 42 Sp and Magnetom 63 Sp | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K883720 | Trend(r) Emerge(tm) Toxoplasma Igg Elisa | Lmd Laboratories | LGD | Class II | |
| K883379 | Models 4000/4900/6000/8000/8900 Nd:yag & 1700 CO2 | Heraeus Lasersonics, Inc. | GEX | Class II | |
| K882826 | Softrac-Pta Peripheral Dilatation Catheter | Schneider-Shilley (USA) | LIT | Class II | |
| K882517 | Rodenstock Scanning Laser Ophthalmoscope | Rodenstock Instrument Corp. | HLI | Class II | |
| K881344 | Aca Ethyl Alcohol (Alc) Analytical Test Packs | E.I. Dupont de Nemours & Co., Inc. | DIC | Class II | |
| K890041 | V-Trend Target Im Test | Texas Immunology, Inc. | KTN | Class II | |
| K890030 | New Low Level Drug Mixture Control | Rapid Diagnostic Laboratories, Inc. | DIF | Class I | |
| K890002 | Coat-a-Count (Tm) Theophylline | Siemens Healthcare Diagnostics Inc. | KLS | Class II | |
| K884883 | 28 Additional Allergen Modules for Alastat(tm) | Siemens Healthcare Diagnostics Inc. | DHB | Class II | |
| K884704 | Uric Acid Test (Uric) Item #65620 | Em Diagnostic Systems, Inc. | KNK | Class I | |
| K884703 | Total Protein Test (Tp) Item #65670 | Em Diagnostic Systems, Inc. | CEK | Class II | |
| K884600 | Technicon System Ra-100/Assist Magnesium | Technicon Instruments Corp. | JGJ | Class I | |
| K884146 | Albuwell | Exocell, Inc. | JIR | Class I | |
| K883327 | Clinistat Bun (Blood Urea Nitrogen) Reagent Test | Kulzer GmbH | JGZ | Class II | |
| K885219 | Dental Dressing Pliers | Wen Hao, Inc. | EKJ | Class I | |
| K885218 | Discard Dental Mirror | Wen Hao, Inc. | EKJ | Class I | |
| K885217 | Discard Dental Explorer | Wen Hao, Inc. | EKJ | Class I | |
| K884752 | Ketac-Glaze | Espe GmbH (US) | KLE | Class II | |
| K884653 | Racestyptine | Specialites Septodont | EKJ | Class I | |
| K884615 | Ati-Pymah Disposable Steam Biological Test Pack | Pymah Corp., Ati Div. | FRC | Class II | |
| K884540 | Etv, Electronic Vision Aid | Sevrain-Tech, Inc. | HPE | Class I | |
| K884472 | Air-Electronic Air Cleaner (Filter) | White-Rodgers, Div. Emerson Electric Co. | FRF | Class II | |
| K884464 | Spirometrics Model 2200 Sm200 Flow Sensor | Spirometrics, Inc. | JAX | Class II | |
| K884434 | Vortech's Medical Imaging Gateway | Vortech Data, Inc. | LMD | Class I | |
| K883905 | Arrow Pneumothorax Kit, Ak-01500 | Arrow Intl., Inc. | JOL | Class II | |
| K882609 | Models M1175a & M1176a Component Monitoring System | Waltham Div. Hewlett Packard | DRT | Class II | |
| K885346 | Non-Sterile Vinyl Gloves | Daw Shin Industrial Co., Ltd. | FMC | Class I | |
| K884671 | Exel 2400 and 2400 Elite CT Scanners | Elscint, Inc. | JAK | Class II | |
| K884670 | Exel 1800 and 1800E CT Scanner | Elscint, Inc. | JAK | Class II | |
| K884583 | Bte Hearing Aid Siemens Model 284Pp-Asp | Siemens Hearing Instruments, Inc. | ESD | Class I | |
| K884502 | Usci 8F Extra Large Lumen Guide Catheter | C.R. Bard Inc | DQO | Class II | |
| K884500 | Alta Non-Reamed Tibial Rod | Howmedica Corp. | HSB | Class II | |
| K884483 | Cruciometer | Mizuho Orthopedic Systems Inc | JZE | Class I | |
| K884410 | Omnifit Total Knee Series Iii,iv & Post. Stab. Fem | Osteonics Corp. | JWH | Class II | |
| K885314 | Hpd Sterile Humidifying Chamber | Hpd Medical, Inc. | BTT | Class II | |
| K885033 | Model 3487A Pisces Epidural Lead | Medtronic, Inc. | GZB | Class II | |
| K885022 | Magnesium Test Item Number: Sr1019 | Em Diagnostic Systems, Inc. | JGJ | Class I | |
| K884973 | Fr6000 Flowmeter | Key Instruments | CAX | Class I |