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 |
|---|---|---|---|---|---|
| K063431 | 15.5 Fr Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, Dfc19sh24, Dfc23sh28, Dfc27sh32, Dfc31sh36, Dfc35sh40 | Spire Biomedical, Inc. | MSD | Class II | |
| K063300 | Bd Phoenix Automated Microbiology System - Cefpodoxime (Gn) 0.125-8Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K062925 | Coaguchek Xs System | Roche Diagnostics GmbH | GJS | Class II | |
| K062615 | Vision Biosystems Progesterone Receptor Pgr Clone 16 | Vision Biosystems, Inc. | MXZ | Class II | |
| K062559 | Urgocell Ag Antimicrobial Wound Dressing with Silver | Laboratoires Urgo | FRO | Unclassified | |
| K062530 | Triage Protein C Test | Biosite Incorporated | GGP | Class II | |
| K070196 | Flight Dental Systems a-Series Dental Operative Unit | Hr Dental Products, Inc. | EIA | Class I | |
| K070040 | Powdered Vinyl Patient Examination Gloves, White | Super Safe Plastic Products Co., Ltd. | LYZ | Class I | |
| K070019 | Carrara Volumia | Dentsply Intl. | EIH | Class II | |
| K063851 | Auto-Fill Syringe Kit, Model 7600 | Vascular Solutions LLC | FMF | Class II | |
| K063846 | Eigen Dsa 2000 | Eigen | LLZ | Class II | |
| K063819 | Asahi Ptca Guide Wire, Fielder Fc | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K063630 | Atricure Ablation System | AtriCure, Inc. | GEI | Class II | |
| K063567 | Ez-Mio Sternal | Teleflex Medical | FMI | Class II | |
| K063530 | On-Q, Painbuster, C-Bloc, Select-a-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step Kvo, Easypump | Halyard Health | MEB | Class II | |
| K063510 | Lifepak 12 Defibrillator/monitor | Physio Control, Inc. | MKJ | Class III | |
| K063378 | Cirrus Hd-Oct, Model 4000 | Carl Zeiss Meditec Inc | HLI | Class II | |
| K063272 | Dimension Vista B2mic Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium, Control High | Siemens Healthcare Diagnostics Inc. | JZG | Class II | |
| K062913 | Astraguard Pulmonary Function Filter | Sdi Diagnostics, Inc. | BZG | Class II | |
| K062712 | Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/n 20139-094 | Erbe USA Inc | GEI | Class II | |
| K062535 | K-Y Brand Touch Massage 2-in-1 Tingling | Mcneil-Ppc, Inc. | NUC | Class II | |
| K062528 | Tissue Site Marking System | Hologic, Inc. | NEU | Class II | |
| K062354 | Vectra Genisys Vms Fr | Encore Medical, LP | IPF | Class II | |
| K061898 | Ezlase | Biolase MG LLC | GEX | Class II | |
| K061499 | Osferion | OLYMPUS Corporation of the Americas | MQV | Class II | |
| K061419 | Teco Microalbumin 2-1 Combo Strips | Teco Diagnostics | JIR | Class I | |
| K061297 | Anspach Imri Safe Surgical Drill System | The Anspach Effort, Inc. | HBB | Class II | |
| K070155 | Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E, Motor Int-D and Attachment Int-Snc | Osseo Scientific, LLC | EFB | Class I | |
| K070071 | Omniguide Zero Flow Zf-T Waveguide Fiber | Omni-Guide Holdings, Inc. | GEX | Class II | |
| K070010 | Quikclot Sport and Quikclot Sport Silver | Z-Medica, LLC | QSY | Unclassified | |
| K063834 | Revlite C6 Q-Switched Nd:yag Laser System | Hoya Conbio, Inc. | GEX | Class II | |
| K063828 | Diomed Delta 25 | Diomed, Inc. | GEX | Class II | |
| K063822 | Modification to Hipstar Femoral Stem | Stryker Orthopaedics | LPH | Class II | |
| K063797 | Geodesic EEG System 300 | Electrical Geodesics, Incorporated | OLT | Class II | |
| K063666 | Sharps Container, Model 039-413 | Sport Medical Technology Inc | MMK | Class II | |
| K063664 | Gen-Probe Aptima Assay for Neisseria Gonorrhoeae Model#1091 | Hologic, Inc. | LSL | Class II | |
| K063601 | Pilot Spinal System | Life Spine | MNI | Class II | |
| K063590 | V.a.c. Freedom Canister, Model M6275421; V.a.c. Ats Canister, Models K6275422, M6275423 | KCI USA, Inc. | OMP | Class II | |
| K063586 | Moorflpi Full-Field Laser Perfusion Imager | Moor Instruments Ltd. | DPT | Class II | |
| K063577 | Femoral Intrafix Screw and Sheath | Johnson & Johnson | MBI | Class II | |
| K063450 | Portex Hypodermic Needle- Pro Edge Safety Device, 18Gx1, 401810, 19Gx1, 401910, 20Gx1,402010, 21Gx1402110 | Abbott Medical | FMI | Class II | |
| K063377 | Powerport Polymetric Port with 8 Fr S/l Chronoflex Catheter | C.R. Bard Inc | LJT | Class II | |
| K062899 | Microtek Medical Surgical Gown/toga | Microtek Medical LLC | FYA | Class II | |
| K062666 | Vusion Ts, Ps, and Cs Partial Vertebral Body Replacements | Ortho Development Corp. | MQP | Class II | |
| K062397 | Sentinel | GE Healthcare | DXH | Class II | |
| K062099 | Phase 3, Model Dt-1 | Datrend Systems Inc | DRL | Class II | |
| K062082 | Conmed Abc Dissecting Blade Electrode, Model 139330; Blunt Needle Electrode, Model 139331 | ConMed Corporation | GEI | Class II | |
| K061886 | Actim Prom and Controls | Medix Biochemica | OAM | Class I | |
| K061554 | Mepilex Ag Absorbent Silicone-Coated Dressing | Molnlycke Health Care | FRO | Unclassified | |
| K061242 | Dermatherapy, Model 22216 | Precision Fabrics Group, Inc. | FMW | Class I |