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 |
|---|---|---|---|---|---|
| K983450 | Starryshine Gauze Sponge | T.C. Dental Products, Inc. | EFQ | Unclassified | |
| K983323 | Digoxin Immunoassay | Diagnostic Reagents, Inc. | KXT | Class II | |
| K983185 | Boehringer Mannheim Tina-Quant Ige Test | Boehringer Mannheim Corp. | DGC | Class II | |
| K982906 | Lorenz Intraoral Linear Mandibular Distraction System | Biomet Microfixation | MQN | Class II | |
| K982831 | Auto-Lyte Benzodiazepines Eia Model Number 1210U | OraSure Technologies, Inc. | JXM | Class II | |
| K981911 | Profa | Duncan Hynd Associates, Ltd. | IYE | Class II | |
| K981885 | Sunrise Scooter Series, Model Unassigned, 3 Wheel Standard Model, 3 Wheel Mid Range Model, 3 Wheel High End Model, 4 Whe | Sunrise Medical, Inc. | INI | Class II | |
| K981072 | Esprit Ventilator | Respironics, Inc. | CBK | Class II | |
| K980711 | Harris/galante Porous (Hgp) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer GmbH | LPH | Class II | |
| K974241 | Scimed Informer Pressure Wire System | Scimed Life Systems, Inc. | DQX | Class II | |
| K983736 | Icel Evolusonic Portable Ultrasonic Nebulizer | Brasamerica Medical Equipment, Inc. | CAF | Class II | |
| K983603 | Reflective Sphere Standard Probe and Reflective Sphere Dynamic Reference Frame | Radionics, Inc. | HAW | Class II | |
| K983554 | Alldress, Absorbent Film Dressing | Molnlycke Health Care | KMF | Class I | |
| K983112 | Respiratory Humidifier, Model # Mr850 | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K983033 | Acs Ht Balance Middleweight Guide Wire | Boston Scientific Corporation | DQX | Class II | |
| K982975 | Digital ECG Holter Recorder, Model Dr512 | Datrix LLC | MWJ | Class II | |
| K982902 | Peripheral Nerve Stimulation | Medtronic, Inc. | GZF | Class II | |
| K982876 | Hi-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281, 1003282 | Boston Scientific Corporation | DQX | Class II | |
| K982854 | Mr Compatible Leveen Needle Electrode | Radiotherapeutics Corp. | GEI | Class II | |
| K982843 | Cms-2000 | Industrial Technology Research Institute | MWJ | Class II | |
| K973322 | Diapact Crrt | B.Braun Medical, Inc. | KDI | Class II | |
| K983478 | Organic Essentials, Organic Cotton Tampon | Organic Essentials | HEB | Class II | |
| K983266 | Fibrekor Post System | Jeneric/Pentron, Inc. | ELR | Class I | |
| K982840 | Bsc Sonicath Ultra Intravascular Ultrasound Imaging Wire with Detachable Adapter & Bsc Sonicath Ultra Ultrasound Imaging | Boston Scientific Corporation | IYO | Class II | |
| K982167 | Cyto-Stat Trichrome Cd45-Fitc/cd19-Rd1/cd3-Pc5 Monoclonal Antibody Reagent with Cyto-Stat Trichrome Cd45-Fitc/msigg1-Rd1 | Coulter Corp. | GKZ | Class II | |
| K982043 | Breneb | Bremed Italia, S.r.l. | CAF | Class II | |
| K981871 | C-Reactive Protein Elisa, Model Number Dsl-10-42100 | Diagnostic Systems Laboratories, Inc. | DCK | Class II | |
| K980800 | Low Viscosity Composite Temporary (Provisional) Material | Cosmedent, Inc. | EBF | Class II | |
| K983684 | Datex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse Oximeters | GE Healthcare | DQA | Class II | |
| K983677 | Quickie G Series, Model G-424 | Sunrise Medical, Inc. | ITI | Class II | |
| K983632 | Siemens Sc 8000 Bedside Monitor | Siemens Medical Solutions USA, Inc. | DSI | Class II | |
| K983585 | Low Ph Phenolic 256 | Central Solutions, Inc. | LRJ | Class I | |
| K983581 | Ocu-Guard and Ocu-Guard Supple | Bio-Vascular, Inc. | HQX | Class II | |
| K983538 | Miniaturized Biopsy,scope A.k.a: Biopsy Needle with Endoscopic Viewing Capability | Solos Endoscopy, Inc. | GCJ | Class II | |
| K983520 | Breath Control (Breath Actuator), Sensitouch Breath Control, Head Array (Switch Head Control), Tri-Switch Head Array, Hd | Sunrise Medical, Inc. | ITI | Class II | |
| K983407 | Aceme Jupiter Scooter, 4-Wheeled,model Jupiter 50F | Aceme Technologies Intl. | INI | Class II | |
| K983405 | Aceme Jupiter Scooter, 3-Wheeled, Model Jupiter 50 | Aceme Technologies Intl. | INI | Class II | |
| K983367 | Qlicksmart | Handren Assoc. | MMK | Class II | |
| K983283 | Signet Dxis Direct X-Ray Imaging System | Signet Radiology, Inc. | MUH | Class II | |
| K983280 | Vancomycin Eia Assay | Diagnostic Reagents, Inc. | LEH | Class II | |
| K983218 | N,i.t., Inc. Automatic Cutting Biopsy Needle | Avid N.I.T., Inc. | FCG | Class II | |
| K983141 | Capitello-Condylar Total Elbow Prosthesis | Johnson & Johnson Professionals, Inc. | JDB | Class II | |
| K983092 | Triton Hudson Chuck Attachment | Mednext, Inc. | HBB | Class II | |
| K983025 | Xomed Feathertouch Xps Power Rasp Attachment | Xomed, Inc. | HRX | Class II | |
| K982933 | Vinyl Examination Gloves, Powder Free | General Gloves Corp. | LYZ | Class I | |
| K982837 | Ksea Gaab Neuroendoscope and Chavantes-Zaamorano Neuroendoscope Sets | Karl Storz Endoscopy-America, Inc. | GWG | Class II | |
| K982830 | Forte, Models Cps 400 Combo, Cps 200 Combo | Chattanooga Group, Inc. | IMG | Class II | |
| K982829 | Forte, Model Cps Ultrasound | Chattanooga Group, Inc. | IMI | Class II | |
| K982828 | Forte, Models Cps 400 Stim, Cps 200 Stim | Chattanooga Group, Inc. | IPF | Class II | |
| K982826 | Mega 2000 | Megadyne Medical Products, Inc | GEI | Class II |