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 |
|---|---|---|---|---|---|
| K082086 | Key Ring Alcohol Breathalyzer | The Ashley Collection, Inc. | DJZ | Class I | |
| K081930 | Unicel Dxh 800 Coulter Cellular Analysis System | Siemens Healthcare Diagnostics Inc. | GKZ | Class II | |
| K081920 | Bd Geneohm Cdiff Assay | BD Diagnostics (Geneohm Sciences, Inc.) | LLH | Class I | |
| K081855 | Impair Aware Alcohol Level Indication System (Alis) | Canada, Inc. | DJZ | Class I | |
| K081827 | Human Iga Liquid Reagent Kit for Use on Spaplus | The Binding Site | CFN | Class II | |
| K081751 | Adin Dental Implants System | Adin Dental Implants System, Ltd. | DZE | Class II | |
| K081608 | Proximal Humerus Scaffold Fixation System (Phsfs) | Toby Orthopaedics | HRS | Class II | |
| K081309 | E.coli/p. Aeruginosa Pna Fish | Advandx, Inc. | JSS | Class I | |
| K081207 | Intuitive Surgical Da Vinci S Surgical System, Model Is2000, with Da Vinci Connect and Onsite | Intuitive Surgical, Inc. | NAY | Class II | |
| K081083 | Cedia Mycophenolic Acid Assay, Calibrators, Mas Mycophenolic Acid Controls | Thermo Fisher Scientific Oy | OAV | Class II | |
| K083527 | Intelligent Articulating Endoscopic Linear Cutter Reverse with Reloads | Power Medical Interventions, Inc. | GDW | Class II | |
| K083437 | Modification to T2 Recon Nail System | Howmedica Osteonics Corp | HSB | Class II | |
| K083413 | Compurecord Peri-Operative Anesthesiology Information System | Philips North America LLC | BSZ | Class II | |
| K083301 | X-Coated Terumo and Sarns Dual Stage Venous Return Catheters, Sarns Malleable Venous and Dual Stage Return Catheters | Terumo Cardiovascular Systems Corporation | DWF | Class II | |
| K083042 | Wound Flush, Sterile Water & Normal Saline | Nurse Assist, LLC | FRO | Unclassified | |
| K082956 | Alpha Orthopaedics At2 System | Alpha Orthopaedics | GEI | Class II | |
| K082925 | Xenon-100 Scb Light Source, Model 20132620 | Karl Storz Endoscopy-America, Inc. | GCT | Class II | |
| K082837 | Sterile Field Saline Pre-Filled Syringe(s) | Excelsior Medical LLC | NGT | Class II | |
| K082809 | Acupulse 30 and 40 Carbon Dioxide Laser System | Lumenis Ltd | GEX | Class II | |
| K082765 | Astoflo Plus | Stihler Electronic GmbH | LGZ | Class II | |
| K082715 | Depuy Global Ap Cta Humeral Head | Depuy Orthopaedics Inc. | HSD | Class II | |
| K082701 | Uronirs, Model 2000 | Urodynamix Technologies, Ltd. | FEN | Class II | |
| K082676 | Genadyne A4 Wound Vacuum System | Genadyne Biotechnologies, Inc. | OMP | Class II | |
| K082527 | Zimmer Universal Locking System: 3.5 Mm Locking Plates and Screws | Zimmer GmbH | HRS | Class II | |
| K082233 | Viky | Endocontrol | GCJ | Class II | |
| K082079 | Regen Collagen Scaffold (Cs) | Regen Biologics, Inc. | OLC | Class II | |
| K081355 | Bioflex Ld-R100 Treatment Head | Meditech International Inc | ILY | Class II | |
| K080172 | Blastassist without Phenol Red, Model Ref 1215, Blastassist with Phenol Red, Model Ref 1216 | Medicult A/S | MQL | Class II | |
| K080149 | Heater Base, Model Pmh7000 | Pacific Medico Co., Ltd. | BTT | Class II | |
| K083610 | Filtek Supreme Ultra Universal Restorative | 3M Company | EBF | Class II | |
| K083498 | Philips Model Mx 16 Slice CT System | Philips North America LLC | JAK | Class II | |
| K083392 | Novation 12/14 Cemented Femoral Stems | Exactech, Inc. | LZO | Class II | |
| K082985 | A-Dec 334/335 Delivery System | A-dec, Inc. | EIA | Class I | |
| K082904 | Stasys Motion Correction Software | Digirad Corp. | KPS | Class II | |
| K082783 | Cadd -Solis Medication Safety Software: Administrator and Point-of-Care | Abbott Medical | MRZ | Class II | |
| K082766 | Modification to Minispir, Spirolab III | Mir Medical Intl. Research SRL | BZG | Class II | |
| K082731 | Ml24000 Uva-1 Phototherapy Cabinet | The Daavlin Distributing Co. | FTC | Class II | |
| K082725 | Graftguard Pressure Controlling Syringe | Maquet Cardiovascular LLC | GBX | Class I | |
| K082631 | Thrombo Tek Pse, Model 90-480 | R2 Diagnostics, Inc. | GGP | Class II | |
| K082625 | Synthes (USA) 3.5Mm Lcp Periarticular Proximal Humerus Plates | Synthes (USA) Products LLC | HRS | Class II | |
| K082590 | Symphony Meter Remote | Lifescan, Inc. | LZG | Class II | |
| K082481 | Flowpicc Catheter | Teleflex Medical | LJS | Class II | |
| K082421 | Heartsuite Hemodynamics 7.10 | Merge Healthcare Incorporated | DQK | Class II | |
| K082344 | Stockert S5 System, Stockert Electrical Venous Occluder (Evo) | LivaNova Deutschland GmbH | DWF | Class II | |
| K082180 | Perma Fiber,model 441; Perma Mesh, Model 440 | Angelus Industria de Productos Odontologicos | EBI | Class II | |
| K082116 | Hemostasyl Paste | Satelec | MVL | Unclassified | |
| K082094 | Bard PTFE (Teflon) Coated Guide Wires | C.R. Bard Inc., Bard Electrophysiology Division | DQX | Class II | |
| K081960 | Invisalign System | Align Technology, Inc. | NXC | Class II | |
| K081814 | Reprocessed ENT Shavers | Sterilmed Inc | ERL | Class II | |
| K081788 | Infrared Ear Thermometer, Models Innotherm Ict-100 and Ict-200 | Innochips Technology Co., Ltd. | FLL | Class II |