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 |
|---|---|---|---|---|---|
| K905454 | Advance Suture Nonabsorbable Silk Suture | Advance Suture, Inc. | GAP | Class II | |
| K904963 | Extend Track Unit | Anthony Chiropractic Clinic, Inc. | BXB | Class I | |
| K904809 | Universal Compression Screw | Howmedica Corp. | HWC | Class II | |
| K904469 | Eyeopener | Kc Medical Industries | JYJ | Class I | |
| K903177 | Advance Suture Nonabsorbable Nylon Suture | Advance Suture, Inc. | GAR | Class II | |
| K903176 | Advance Suture Nonabsorbable Polypropylene Suture | Advance Suture, Inc. | GAW | Class II | |
| K900206 | Lyme Disease Igm Elisa | Hillcrest Biologicals | LSR | Class II | |
| K912252 | Infinity(r) Transilluminator Examination Light | Fiberoptic Medical Products, Inc. | FST | Class II | |
| K912083 | Latex Patient Examination Gloves, Hypoallergenic | Sterigard, Inc. | LYY | Class I | |
| K911684 | Biomet Cobalt-Chrome Femoral Components | Zimmer GmbH | JDI | Class II | |
| K911677 | Selector 3 | Metalor Dental USA Corp. | EJS | Class II | |
| K911675 | Pagalin 2 | Metalor Dental USA Corp. | EJS | Class II | |
| K911668 | Cerapall 2 | Metalor Dental USA Corp. | EJS | Class II | |
| K911629 | Serim Formaldehyde Reagent Strips (2.5% -4.0%) | Serim Research Corp. | LIF | Class II | |
| K911628 | Serim Formaldehyde Reagent Strips (1.O% -2.0%) | Serim Research Corp. | LIF | Class II | |
| K911398 | Asnis 2 Small Diameter Cannulated Screw System | Howmedica Corp. | HWC | Class II | |
| K911161 | Inerpan(tm) Temporary Wound Dressing | Laboratories Delalande | MGP | Unclassified | |
| K910890 | Non-Sterile Clinical Style Paraderm Glove Liner | Lovell-Schenck, Inc. | LYU | Class I | |
| K910807 | Keane Uni Knee System | Depuy, Inc. | HSX | Class II | |
| K905569 | Electro-Nerve Stimulator Tens,model Systems Plus/a | BioMedical Life Systems Inc. | GZB | Class II | |
| K912571 | Phonak Phonica Model 312-Sc Ite Hearing Instrument | Phonak, Inc. | ESD | Class I | |
| K912570 | Phonak Phonica Model 312-C Ite Hearing Instrument | Phonak, Inc. | ESD | Class I | |
| K912309 | Standard S33 | Metalor Dental USA Corp. | EJS | Class II | |
| K912306 | Standard S4 | Metalor Dental USA Corp. | EJS | Class II | |
| K912304 | Standard S2 | Metalor Dental USA Corp. | EJS | Class II | |
| K912303 | Standard S1 | Metalor Dental USA Corp. | EJS | Class II | |
| K912300 | Vs11 | Metalor Dental USA Corp. | EJS | Class II | |
| K912299 | Vs1b | Metalor Dental USA Corp. | EJS | Class II | |
| K912298 | Vs1 | Metalor Dental USA Corp. | EJS | Class II | |
| K912297 | Vs1g | Metalor Dental USA Corp. | EJT | Class II | |
| K911811 | Siemens Model 604 Pp-L, Behind-the-Ear Hearing Aid | Siemens Hearing Instruments, Inc. | ESD | Class I | |
| K911810 | Siemens Model 604 Pp, Behind-the-Ear Hearing Aid | Siemens Hearing Instruments, Inc. | ESD | Class I | |
| K911373 | Osteonics Ion Implant Mod-Ml Uniknee Femoral Comp | Osteonics Corp. | HRY | Class II | |
| K911368 | Maico Ma800 Audiometer | Maico Hearing Instruments, Inc. | EWO | Class II | |
| K912366 | Mainster High Magnification Laser Lens | Ocular Instruments, Inc. | HJK | Class II | |
| K912026 | Delfia(r) 17 -Oh-Progesteron Kit | Pharmacia Diagnostics, Inc. | JLX | Class I | |
| K911808 | Gemini Ophthalmic Surgery System | Alcon Laboratories | HQC | Class II | |
| K911721 | Keeler Pulsair Non Contact Tonometer, Modification | Keeler Instruments, Inc. | HKX | Class II | |
| K911460 | .010 Hi-Torque Guide Wires with Preshaped Tip | Advanced Cardiovascular Systems, Inc. | DQX | Class II | |
| K911384 | Cathscanner(r) Visions(tm) 3.5F 54700/5.0F 54600 | Endosonics Corp. | DXK | Class II | |
| K911298 | Pressure Limiting Elbow with Manometer Port | Intertech Resources, Inc. | BTM | Class II | |
| K911099 | Mehigan-Pilling Angioscopic Vascular Instrum. Line | Pilling Co. | DWX | Class II | |
| K910769 | Surgitek(r) Ercp Contrast Media System | Surgitek Medical Engineering Corp. | ODD | Class II | |
| K910116 | Turbo Support Catheter | Datascope Corp. | DQY | Class II | |
| K905092 | Neuromuscular Transmission Monitor | Utah Medical Products, Inc | BXN | Class II | |
| K903001 | Slimcath (Tm) | Gynopharma, Inc. | HIT | Class I | |
| K912544 | Bipolar Forceps | Everest Medical Corp. | MAV | Class II | |
| K912458 | Model 404-Sp and 504-Sp Infusion Pumps Modified | Medtronic, Inc. | FRN | Class II | |
| K912348 | Sx90 (Tm),model 4800S | Medical Devices Inc. | GZJ | Class II | |
| K912149 | Hardcoated Plastic Filling Instrument | Premier Dental Products Co | EKJ | Class I |