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 |
|---|---|---|---|---|---|
| K871239 | Acuson Physiological Control Module | Acuson Computed Sonography | DPS | Class II | |
| K871221 | Cdi(tm) Extracorporeal Blood Gas System 300 | Cardiovascular Devices, Inc. | DRY | Class II | |
| K871208 | Unipolar Endocardial Screw-in Lead, Model 1007M | Pacesetter Systems | DYB | Class II | |
| K871149 | Drm 2300 Plethysmographic Cardiotachometer | Iontec Corp. | DRT | Class II | |
| K871040 | Consultant Body Composition Analyzer | Body Composition Analog, Inc. | DSB | Class II | |
| K870742 | American Lubricating Jelly Sterile 2.7G & 5G | Span-America Medical Systems, Inc. | KMJ | Class I | |
| K870460 | Dorros(tm) Small Vessel Pta Catheter | C.R. Bard Inc | DXN | Class II | |
| K864589 | Tri-Service Omv Vaporizer | Bear Medical Systems, Inc. | BSZ | Class II | |
| K871780 | Ultraviolet Aspartate Amino-Trans (UV-Ast/uv-Got) | Biochemical Trade, Inc. | CIT | Class II | |
| K871462 | Prosthetic - Femoral Hip Component | Louis A. Serafin, Jr., M.D. | JDI | Class II | |
| K871376 | First Aid Kit, Various Sizes | Fraass Survival Systems, Inc. | LRR | Not classified | |
| K871219 | Titanodont Subcortical Implant with Porocoat | Depuy, Inc. | DZE | Class II | |
| K871003 | Entroset-Sw | White River (Tm) | KNT | Class II | |
| K870992 | Imed(r) Model 965A Volumetric Infusion Pump | Imed Corp. | FRN | Class II | |
| K870991 | Imed(r) Model 960A Volumetric Infusion Pump | Imed Corp. | FRN | Class II | |
| K870897 | Kodner Anal Perioneal Retractor | Sur-Med Instruments, Inc. | FFO | Class I | |
| K870814 | Herpes Simplex Antibody Test for Dect. of Hsv 1&2 | Microscan Div. Baxter Healthcare Corp. | GQL | Class II | |
| K864645 | Adenolex (R) Latex Agglutination Test | Orion Diagnostica, Inc. | GOD | Class I | |
| K871961 | Multiple Spectacle Lens | Korea Asahi Optical Co., Ltd. | HQG | Class I | |
| K871943 | D.a.t. (Tm) Amylase Reagent | Behring Diagnostics, Inc. | CIJ | Class II | |
| K871935 | T P C (Tonometer Probe Cover) | Krb Ent. | HKX | Class II | |
| K871902 | The Uric Acid Reagent Set | Macomb Biotechnology, Inc. | KNK | Class I | |
| K871781 | Ultraviolet Lactate Dehydrogenase Reagent Set | Biochemical Trade, Inc. | CFJ | Class II | |
| K871772 | Kinematic III Post Cruciate Total Condylar Knee Sy | Howmedica Corp. | JWH | Class II | |
| K871735 | Voroscope(tm) | Australian Biomedical Corporation, Ltd. | HLJ | Class II | |
| K871485 | Site Phacoemulsification System/ophthalmic Use | Site Microsurgical Systems, Inc. | HQC | Class II | |
| K871450 | 25Mm Peyman Wide Field Yag Laser Lens | Ocular Instruments, Inc. | HJK | Class II | |
| K871397 | Analyzer: Nova Stat Profile 3 Analyzer | Nova Biomedical Corporation | CHL | Class II | |
| K871248 | Kronner Colles-Forearm External Fixation | Kronner Medical | KTT | Class II | |
| K871235 | Tandem(r) Icon(r) Qsr(tm) Hcg Immuno. Assay Kit | Hybritech, Inc. | JHI | Class II | |
| K870979 | Hemodialysis Concentrates & Related Products | Inventory Supply Corp. | KPO | Class II | |
| K870626 | Freedom Set II with Triflex Valve | Delmed, Inc. | KDJ | Class II | |
| K870095 | Bilirubin Tester | FUJIFILM Healthcare Americas Corporation | CIG | Class II | |
| K872020 | Mucate Agar, Slants and Mucate Broth | BD Becton Dickinson Vacutainer Systems Preanalytic | JSH | Class I | |
| K871769 | Omnifit(r) Total Knee System (Modification) | Osteonics Corp. | JWH | Class II | |
| K871501 | Kit, First Aid, General Purpose, Rigid Case | Fraass Survival Systems, Inc. | LRR | Not classified | |
| K871292 | Health Concepts Conductive Membrane | Health Concepts, Inc. | GXY | Class II | |
| K871126 | Electro-Nerve Stimulator TENS Model C & B11, B11c | BioMedical Life Systems Inc. | GZJ | Class II | |
| K871125 | Electro-Nerve Stimulator TENS Model B5/skn | BioMedical Life Systems Inc. | GZJ | Class II | |
| K870411 | Central Vein Catherization Kit W/without Medica. | Medical Surgical Concepts, Inc. | DQY | Class II | |
| K864745 | Poet Oximeter | Criticare Systems, Inc. | DQE | Class II | |
| K863815 | Electroconvulsive Therapy Device, Model Mf-1000 | Elcot, Inc. | QGH | Class II | |
| K863439 | Intrauterine Hemostasis Balloon Stent | Mentor | KNA | Class II | |
| K871925 | Straight Cup Currette, 1.7Mm | Arthropedics, Inc. | FZS | Class I | |
| K871924 | Sterilization Tray, Tmj Instrument Set | Arthropedics, Inc. | FSM | Class I | |
| K871923 | Micro Scissor, 1.7Mm | Arthropedics, Inc. | LRW | Class I | |
| K871910 | Surgitek Disposable Bipolar Cord | Dermacare Products, Inc. | GEI | Class II | |
| K871901 | Ultraflow | Custom Industries, Inc. | FZH | Class II | |
| K871692 | Tracheostomy & Nasal Suctioning Kit, 3C-Tns-1 | Automatic Liquid Packaging, Inc. | LRQ | Class I | |
| K871672 | Sterilization Indicator for Flash Sterilization | Propper Mfg Co Inc | LRT | Class II |