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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K912337 | Electrosurgical Cut & Coagulation Device & Access | Megadyne Medical Products, Inc | GEI | Class II | |
| K912206 | Micro-Aire Arthros Surg Blades-Various Co Prod No. | Microaire | HRX | Class II | |
| K912205 | Micro-Aire Arthros Surg Blades-Various Dys Prod No | Microaire | HRX | Class II | |
| K912201 | Packs-4 (Tm) Analyzer | Helena Laboratories, Corp. | JBY | Class II | |
| K912124 | Tracheostomy Tube and Cuff | Concord/Portex | BTO | Class II | |
| K911746 | H.i.standard Calibre Upgrade | Health Images, Inc. | LNH | Class II | |
| K911728 | Omnifit(r) Epf Dual Geomtry/radius/thread Acetab C | Osteonics Corp. | MEH | Class II | |
| K911692 | Enzymatics, Inc., Total Cholesterol Test | Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | CHH | Class I | |
| K911674 | Ceraplus | Metalor Dental USA Corp. | EJS | Class II | |
| K911669 | Cerapall 6 | Metalor Dental USA Corp. | EJS | Class II | |
| K911217 | Sr1 T4 Enzyme Immunoassay (Magnetic Solid-Phase) | Serono-Baker Diagnostics, Inc. | KLI | Class II | |
| K910938 | Codman External Drainage System II (Eds II) | Cerenovus, Inc. | JXG | Class II | |
| K910846 | Bard Latex Urinary Catheters Drains- Designs Modif | C.R. Bard Inc | EZC | Class II | |
| K910611 | Nobelpharma Ceraone Abutment System | Nobelpharma USA, Inc. | DZE | Class II | |
| K910190 | Bard Monopty Disposable Core Biopsy Instrument | C.R. Bard Inc | KNW | Class II | |
| K910062 | 02-10,001 | Laser Engineering, Inc. | GEX | Class II | |
| K905223 | Octa-Hex (Tm) Implant Restoration Systems | Universal Implant Systems, Inc. | DZE | Class II | |
| K912524 | Expandacel Nasal Tampons, Modification | Surgitrend, Ltd. | EMX | Class I | |
| K912356 | Group Auditory Trainer,fm Receiver | Phonic Ear, Inc. | EPF | Class II | |
| K911328 | Universal Volume Ventilator Circuit, Modification | Intertech Resources, Inc. | BZO | Class I | |
| K911166 | Diagnostic Ultrasound/uro-Gyn Ud 511 | Diagnostic Ultrasound Corp. | DXT | Class II | |
| K911125 | Diagnostic Ultrasound/uro-Gyn Ups 2020 | Diagnostic Ultrasound Corp. | FAP | Class II | |
| K910945 | Horizon 2000 EEG Monitoring Option | Mennen Medical, Inc. | GWQ | Class II | |
| K910787 | Titanium Connector (2 Part) | Accurate Surgical Instruments Co. | FKO | Class II | |
| K910691 | Nortec Ureteral Stent | North American Sterilization & Packaging Co. | FAD | Class II | |
| K910139 | Ver-Med A10014 Resting EKG Electrode & A10021 | Vermont Medical, Inc. | DRX | Class II | |
| K912550 | Duoderm(r) Adhesive Compression Bandage, Modified | Convatec, A Division of E.R. Squibb & Sons | KGX | Class I | |
| K912232 | Ulcercare | Jobst Institute, Inc. | MCY | Class II | |
| K912162 | Intramedullary Hip Screw, Modification | Smith & Nephew Richards, Inc. | KTT | Class II | |
| K911830 | Laserscope(r) Ktp/532 and Ktp/yag Surgical Laser | Laserscope | GEX | Class II | |
| K911492 | Endoscopic Light Source | United States Endoscopy Group, Inc. | GCT | Class II | |
| K911487 | Laparoscopic Cholangiocath | United States Endoscopy Group, Inc. | GCA | Class II | |
| K911485 | Color Video Camera | United States Endoscopy Group, Inc. | FET | Class II | |
| K911477 | Laparoscopic Basket Flexible and Rigid | United States Endoscopy Group, Inc. | LQC | Class II | |
| K911326 | Obstetrical Vacuum Cup | Gesco Intl., Inc. | HDB | Class II | |
| K902772 | Pleasure Plus | Medimix Products, Inc. | HIS | Class II | |
| K912999 | Denta Safe(tm) Latex Examination Gloves | Dental Care Intl., Inc. | LYY | Class I | |
| K912984 | Opti-Plast 5F Pta Catheters, Modification | Vas-Cath, Inc. | LIT | Class II | |
| K912929 | Dash IV | Astro-Med, Inc. | DSF | Class I | |
| K912767 | Fiber Optic Univeral Cables, Scope Adap., Lt.sourc | Microaire Advanced Surgical Products | EQH | Class I | |
| K912410 | Coxel Flinger 2500/5000 3-D Imaging System | Reality Imaging Corp. | LNH | Class II | |
| K912173 | Dsl Beta 2 Microglobulin (Dsl 6100) | Diagnostic Systems Laboratories, Inc. | JZG | Class II | |
| K912171 | Predispensed Orthodontic Ceramic Bracket Adhesive | Jack James | EJF | Class I | |
| K912147 | Osteonics 7000 Series Stand Total Knee Femor Comp | Osteonics Corp. | JWH | Class II | |
| K912029 | Ultrapulse(tm) Carbon Dioxide Surgical Laser | Coherent Medical Group | GEX | Class II | |
| K911987 | Luxus 132 Nd: Yag Surgical Laser System | Heraeus Lasersonics, Inc. | GEX | Class II | |
| K911763 | Laserflo(r) Blood Perfusion Monitor (Model Bpm2) | Vasamedics, LLC | DPW | Class II | |
| K911656 | Pleur-Evac Plus Contin. Reinfus. & Autoinfus. Syst | Pfizer Hospital Products Group, Inc. | CAC | Class II | |
| K910453 | Tops Needle Tip Probe & PVC Tip Probe | Baxter Healthcare Corporation | CCE | Class II | |
| K904639 | Genox Model CT-1 | Pacific Consolidated Industries LLC | CAW | Class II |