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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K812932 | Aneriod Gauze | Abco Dealers, Inc. | DXG | Class II | |
| K812920 | Event Master | Instruments for Cardiac Research | DSH | Class II | |
| K812898 | Pe-01 Electronic Infusion Pump | Egnell, Inc. | FRN | Class II | |
| K812896 | I.v.e. Refraction System | Bausch & Lomb Incorporated | HKO | Class I | |
| K812764 | Koi Blue Field Entoptoscope | Koi, Inc. | HKL | Class II | |
| K812473 | Head Protector | Maddak, Inc. | FMQ | Class I | |
| K812408 | L.o.n. Disposable Coronary Manifold | L.O.N. Research, Inc. | DTL | Class II | |
| K812407 | L.o.n. Reusable Manifolds & Stopcocks | L.O.N. Research, Inc. | DTL | Class II | |
| K812104 | Siemens-Elema Psa 376 | Siemens Corp. | DTA | Class II | |
| K812538 | Elite | Biotone International, Inc. | IPF | Class II | |
| K812132 | Sterile Suture Removal Kit | E.M. Adams Co., Inc. | MCZ | Class I | |
| K813237 | Hemasite Vascular Access Shunt Hm-1000 | Renal Systems, Inc. | FIQ | Class II | |
| K813263 | Patient Underpad | The Buckeye Cellulose Corp. | KME | Class I | |
| K813228 | Connecting Tube | Northern Medical Industries | BYY | Class II | |
| K813192 | Hdl-C Eiken | Syn-Kit, Inc. | LBS | Class I | |
| K813175 | 20Cc Glass Control Syringe | Abco Dealers, Inc. | FMF | Class II | |
| K813146 | Syva Advance Tm Fluorometer | Syva Co. | KHO | Class I | |
| K813144 | Intraflon, Intraflux, Intravalve | Exco, Inc. | DQR | Class II | |
| K813143 | Desilet | Exco, Inc. | DYB | Class II | |
| K813142 | Leader-Cath | Exco, Inc. | DQO | Class II | |
| K813141 | Vygon Stopcocks & Ramps(manifolds) | Exco, Inc. | DTL | Class II | |
| K813140 | Vygon Extension Tubes & Connectors | Exco, Inc. | DQO | Class II | |
| K813131 | Interface Arterial Blood Filter | Medical, Inc. | DTM | Class II | |
| K813123 | Epc Filter | Cerenovus, Inc. | DRR | Class II | |
| K813101 | Cardiobeeper Memory Monitor | Survival Technology, Inc. | DXY | Class III | |
| K813100 | Bio-Stimulator, Model 400 | Med-Western Electronics, Inc. | GZJ | Class II | |
| K813035 | Polystan Verticlude Blood Pump | Advocacy International, Ltd. | DWB | Class II | |
| K813034 | Polystan Heart Lung Machine Sys | Advocacy International, Ltd. | DTQ | Class II | |
| K813013 | Gel Electrode | Arndt Automation & Assoc. | DRX | Class II | |
| K812953 | Radcliffe Ventilator Mark 5 | Cairco, Ltd. | CBK | Class II | |
| K812841 | Total & Direct Bilirubin Reagent Set | Anco Medical Reagents & Assoc. | CIG | Class II | |
| K812833 | Total Protein Reagent Set | Anco Medical Reagents & Assoc. | CEK | Class II | |
| K812792 | Pft Screener (System 1100) | Medical Graphics Corp. | BTY | Class II | |
| K812787 | Eia Rubella | Gilford | LFX | Class II | |
| K812767 | Sniff Air Compressor #Sf-6 | Timeter Instrument Corp. | BTI | Class II | |
| K810286 | Pacepath Implant. Endocard. Pacing Lead | Pacesetter Systems | DTB | Class III | |
| K810139 | Electrode, Pacemaker, Permanent | Pacesetter Systems | DTB | Class III | |
| K813017 | Necktrac | Lossing Orthopedic, Inc. | HST | Class I | |
| K812868 | Fetal Pulse Detectors, F50/f60 | South Carolina Medical, Inc. | KNG | Class II | |
| K813185 | Salicylate Stat-Pak | Clin Tech Diagnostics Corp. | DKJ | Class II | |
| K813167 | Ortho Unassayed Control Serum Level II | Ortho Diagnostic Systems, Inc. | JJY | Class I | |
| K813149 | S/p Vortex Mixer Jr. | American Dade | JRQ | Class I | |
| K813148 | S/p Vortex Mixer | American Dade | JRQ | Class I | |
| K813106 | Port-Op | Portec, Inc. | EIA | Class I | |
| K813102 | Poli-Mak II | Pm America, Inc. | JJE | Class I | |
| K813099 | Back Rie | Back Rite | ION | Class I | |
| K813091 | Fissure Sealer & Bonding Agent | Sci-Pharm, Inc. | EBC | Class II | |
| K813090 | Composite Dental Restorative Material | Sci-Pharm, Inc. | EBF | Class II | |
| K813067 | Spinal Wrench | Twin City Surgical, Inc. | HXC | Class I | |
| K813051 | Comptar III | Cgr Medical Corp. | IZO | Class I |