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 |
|---|---|---|---|---|---|
| K971584 | Clarus Model 2127-900 Series Endoscope Adater (2127-900 Series) | Clarus Medical Systems, Inc. | OCV | Class II | |
| K971423 | Vinyl Patient Examination Glove, Powdered | Shanghai Foremost Plastic Industrial Co., Ltd. | LYZ | Class I | |
| K971415 | Vinyl Patient Examination Glove, Powder-Free | Shanghai Foremost Plastic Industrial Co., Ltd. | LYZ | Class I | |
| K971333 | Synchron Systems Alkaline Phosphatase Reagent, Cholinesterase Reagent, Gamma-Glutamyl Transferase Reagent, Lactate Dehyd | Beckman Instruments, Inc. | JIX | Class II | |
| K971275 | Mill-Rose Disposable Polypectomy Snare | Mill-Rose Laboratory | FDI | Class II | |
| K971125 | Endo Smartcap (100501) | Endo Smart Cap Co. | OCX | Class II | |
| K971100 | Atrion Medical Autogenous Tissue Collector | Atrion Medical Products, Inc. | EIA | Class I | |
| K970933 | Auto Hdl Cholesterol Calibrator | Horiba Instruments Incorporated | JIS | Class II | |
| K970890 | #Es-32 Suction Catheter 32 Fr. | Tri-Med Specialties, Inc. | KNT | Class II | |
| K970077 | Liberty Plus System(pfs-300)/Vaginal Probe, Liberty Plus(pfs-044) | Utah Medical Products, Inc | KPI | Class II | |
| K964718 | Sta D-Di Calibrator Kit | American Bioproducts Co. | DAP | Class II | |
| K964337 | Better-Bladder (Bb) | Circulatory Technology, Inc. | FIB | Class II | |
| K964251 | Occlusion Clamp** Device | United States Surgical, A Division of Tyco Healthc | DXC | Class II | |
| K963803 | Centocor Ca 15-3 Ria Model No. 800-033 | Centocor, Inc. | MOI | Class II | |
| K963779 | Rusch Enteral Feeding Tube | Rusch, Inc. | FPD | Class II | |
| K963738 | Stela Model Bj44 and Bj45 Pacing Leads | Ela Medical, Inc. | DTB | Class III | |
| K971613 | Sil-Tec Small/large Bore Tubing/sil-Tec High Durometer Tubing/sil-Tec Radiopaque Tubing | Technical Products, Inc. | MIB | Class II | |
| K971548 | Ambuvac | KCI USA, Inc. | OMP | Class II | |
| K971430 | Prospore II | Raven Biological Laboratories, Inc. | FRC | Class II | |
| K971422 | Osteonics Acetabular Wedge System | Osteonics Corp. | MEH | Class II | |
| K971341 | Kirwan Model 28 1000 Bipolar Coagulator | Kirwan Surgical Products, LLC | GEI | Class II | |
| K971319 | Nt Series Endodontic Files, Mac Series Endodontic Files | Tycom Dental | EKS | Class I | |
| K971270 | Dsl Active T3 Eia | Diagnostic Systems Laboratories, Inc. | CDP | Class II | |
| K971269 | Dsl Active T4 Eia | Diagnostic Systems Laboratories, Inc. | KLI | Class II | |
| K971173 | Ml Disposable Alk Tubing | Med-logics Inc | KYG | Class I | |
| K971155 | Memoreg | Kulzer GmbH | ELW | Class II | |
| K971025 | Ayurvedic Tongue Cleaner | Calello Martinez P.C. | LCN | Class I | |
| K970997 | Neo-Care Lumber Puncture Kit | Klein-Baker Medical, Inc. | MIA | Class II | |
| K970993 | Deroyal Industries, Inc. Disposable Bipolar Electrosurgical Cable | DeRoyal Industries, Inc. | GEI | Class II | |
| K970900 | Instrument Holder | Domico Med-Device, LLC | GCJ | Class II | |
| K970758 | Duracon Extra-Small Stabilizer Tibial Insert & Baseplate | Howmedica Corp. | JWH | Class II | |
| K970706 | Inter-Op Porous Protrusio Shell with Sealable Screwholes | Sulzer Orthopedics, Inc. | LPH | Class II | |
| K970705 | Inter-Op Porous Revision Shell with Sealable Screwholes | Sulzer Orthopedics, Inc. | LPH | Class II | |
| K970672 | Crystal-EEG Model 10 (Model 10) | Cleveland Medical Devices, Inc. | OMC | Class II | |
| K970605 | 3-Ccd Digital Camera | Envision Medical Corp. | GCJ | Class II | |
| K970280 | Fixano D.s.s. (Double Sliding Screws) System for Osteosynthesis of per-Trochanteroam Fractures | Ferguson Medical | HSB | Class II | |
| K970258 | Fixano D.s.s. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck Fractures | Ferguson Medical | HRS | Class II | |
| K970257 | Fixano D.s.s. (Double Sliding Screws) System for Osteosynthesis of Sub-Trochanterian Fractures | Ferguson Medical | HSB | Class II | |
| K965143 | Osmocyte Wound Manager Sheet Dressing | Procyte Corp. | MGQ | Unclassified | |
| K963369 | Bio-Anchor | Linvatec Corporation | MAI | Class II | |
| K962939 | Vectorvision | Brainlab, Inc. | HAW | Class II | |
| K971534 | Synchron Syustems Dat Drug Free Urine Control | Beckman | DIF | Class I | |
| K971526 | Ace Hdl-C Reagent | Schiapparelli Biosystems, Inc. | LBS | Class I | |
| K971174 | Playtex Gentle Glide Natural Odor Absorbent Tampons | Playtex, Inc. | HEB | Class II | |
| K971164 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens | Aspect Vision Care, Ltd. | LPL | Class II | |
| K971049 | Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted) | Aspect Vision Care, Ltd. | LPL | Class II | |
| K970948 | 800 Series Surgical Laser System and Acccessories | Laserscope | GEX | Class II | |
| K970919 | Synchron Cx Systems Uric Acid (Uric) Reagent | Beckman Instruments, Inc. | KNK | Class I | |
| K970883 | Cedia Digoxin II | Boehringer Mannheim Corp. | KXT | Class II | |
| K970872 | Pan (Chiba Aspirating Needle) | Gallini Intl., Inc. | KNW | Class II |