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 |
|---|---|---|---|---|---|
| K904505 | Cci Corneal Scarifier | Buckman Co., Inc. | GDX | Class I | |
| K902666 | Anesthesia Conduction Filter | Arbor Technologies, Inc. | BSN | Class II | |
| K911568 | Gown, Operating Surgical | Huntsville Rehabilitation Foundation | FYA | Class II | |
| K911559 | Antimicrobial Suscept. Test Panel Cefonicid | Alamar Biosciences Laboratory, Inc. | JWY | Class II | |
| K911557 | Antimicrobial Suscept. Test Panel Ticarcillin | Alamar Biosciences Laboratory, Inc. | JWY | Class II | |
| K911556 | Antimicrobial Suscept. Test Panel Ticarc./clavul. | Alamar Biosciences Laboratory, Inc. | JWY | Class II | |
| K911555 | Anitimicrobial Suscept. Test Panel Amox./clavul. | Alamar Biosciences Laboratory, Inc. | JWY | Class II | |
| K911523 | Modification to Model 90-1460 Laser Adapter | Lifestream Int'L, Inc. | GEX | Class II | |
| K911482 | Laparoscopic Snare | United States Endoscopy Group, Inc. | FDI | Class II | |
| K911481 | Laparoscopic Cleaning Brush Instrument | United States Endoscopy Group, Inc. | FDX | Class II | |
| K911462 | Surgical Trocar | Applied Medical | DRC | Class II | |
| K911305 | Antimicrobial Gentamicin | Alamar Biosciences Laboratory, Inc. | JWY | Class II | |
| K911304 | Antimicrobial Tobramycin | Alamar Biosciences Laboratory, Inc. | JWY | Class II | |
| K911185 | Antimicrobial Ampicillin | Alamar Biosciences Laboratory, Inc. | JWY | Class II | |
| K910894 | Heraeus Lasersonic, Inc Sterile Disposable Fibers | Heraeus Lasersonics, Inc. | GEX | Class II | |
| K910868 | Temperature Well Probe, Twp Series | Gish Biomedical, Inc. | FLL | Class II | |
| K910764 | The Perceptor(tm) Stand Alone Transducer | North American Instrument Corp. | DRS | Class II | |
| K910753 | Fortress Model Spirit 4-Wheel Power Wheelchair | Fortress Litestyle | ITI | Class II | |
| K910751 | Fortress 1600Acv Rear Wheel Drive Scooter | Fortress Litestyle | INI | Class II | |
| K910749 | Fortress Model 760-V 4 Wheel Power Wheelchair | Fortress Litestyle | ITI | Class II | |
| K910510 | Valley Forge Bipolar Pen or Forceps | Valley Forge Scientific Corp. | GEI | Class II | |
| K910494 | Resting EKG Electrode Series | Medtronic Andover Medical, Inc. | DRX | Class II | |
| K910378 | Pressure Monitoring Extension Line | Professional Medical Services | DQO | Class II | |
| K910291 | Model 43420B Newwave Holter System/modification | Hewlett-Packard Co. | DSI | Class II | |
| K910245 | I/a Handpiece with Replaceable Tips | Surgical Technologies, Inc. | GBX | Class I | |
| K905800 | X-T Air Drill | Xomed-Treace, Inc. | ERL | Class II | |
| K905676 | Md CO2 Surgical Laser System/gen. Surgery and Orth | Laser Engineering, Inc. | GEX | Class II | |
| K905133 | Stylet Trachael Tube | Medical Devices Inc. | BSR | Class I | |
| K904832 | Modified Syst: Sonos 500/1000 Ultrsound Imag Syst | Hewlett-Packard Co. | DXK | Class II | |
| K903948 | Intermedics Model 431-11 Implant Endocard Pac Lead | Intermedics, Inc. | DTB | Class III | |
| K911504 | Ultra & Ultra Lite II, Modification | Qualitone | ESD | Class I | |
| K911499 | Elegance - Deo, Modification | Qualitone | ESD | Class I | |
| K911498 | Adjustrette - Dao, Modification | Qualitone | ESD | Class I | |
| K911497 | Custom Personal Ear - Cpe | Qualitone | ESD | Class I | |
| K911377 | Forceps, Coagulation, Bipolar, Malis | International Hospital Supply Co. | GEI | Class II | |
| K911055 | A-Port Implant Vasc Access Syst Line Ext-A2 Port | Therex Corp. | LJT | Class II | |
| K910913 | Moss Gastrostomy Tube | Moss Medical Products | KNT | Class II | |
| K910486 | 8 Fr Single Lumen High Performance Catheter | Davol, Inc. | LJS | Class II | |
| K910479 | Argyle Polyurethane Salem Sump Tube | Sherwood Medical Co. | BSS | Class II | |
| K910377 | Coopersurgical Model 6080 Smoke Evacuator System | CooperSurgical, Inc. | GCX | Class II | |
| K910280 | Ultra-Select Ptca Guidewire | Microvena Corp. | DQX | Class II | |
| K905852 | Strato Plast Port Intro Kt(10 Fr)lps 7013/Modified | Strato Medical Corp. | LJT | Class II | |
| K905850 | Strato Plastic Port Intro(9 Fr)lps 7513/Modified | Strato Medical Corp. | LJT | Class II | |
| K905849 | Strato Plastic Port Intro Kt(10 Fr) Lps 7523/Modif | Strato Medical Corp. | LJT | Class II | |
| K905845 | Strato Port Introducer Kt(9 Fr) Lps 5513/Modified | Strato Medical Corp. | LJT | Class II | |
| K905843 | Strato Plast Introducer Kit(12 Fr) Lps 7113/Modif | Strato Medical Corp. | LJT | Class II | |
| K905842 | Strato Port Introducer Kt(12 Fr) Lps 5213/Modified | Strato Medical Corp. | LJT | Class II | |
| K905841 | Strato Port Introducer Kt(12 Fr) Lps 5200/Modified | Strato Medical Corp. | LJT | Class II | |
| K905840 | Strato Port Introducer Kt(10 Fr) Lps 5057/Modified | Strato Medical Corp. | LJT | Class II | |
| K905839 | Strato Port Introducer Kt(10 Fr) Lps 5013/Modified | Strato Medical Corp. | LJT | Class II |