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 |
|---|---|---|---|---|---|
| K933371 | Imc Endoscopic Instrument Holder | Inman Medical Corp. | GCS | Class II | |
| K932835 | Kendall T.e.d./scd Sequential Compression Device | Kendall Healthcare Products Co. Div.Of Tyco Health | JOW | Class II | |
| K932722 | Carie Med-Tech Model 210 Rainout Drainage System | Carie Med-Tech Services, Inc. | BYH | Class I | |
| K932385 | Suture Removing Forceps | Rocket of London, Ltd. | GEN | Class I | |
| K932326 | Psa Antibody Kit | Ventana Medical Systems Inc | DEH | Class II | |
| K932281 | Verres Needle | Surgeon Surgical Instrumentation, Inc. | GCT | Class II | |
| K932135 | Ott Sunglasses | Sunnex Fashion Corp. | HQY | Class I | |
| K932034 | Palavit 55 and Dentacolor Connector | Kulzer GmbH | EBG | Class II | |
| K931707 | Endoscopic Cable/wire Cover | Mayaguez Medical Center | GCJ | Class II | |
| K931706 | Endoscopic Cable Drape | Mayaguez Medical Center | GCJ | Class II | |
| K931649 | Laparoscopic Balloon Retractor | Cabot Medical Corp. | GCJ | Class II | |
| K931607 | Meddrains | Armm, Inc. | GBN | Class I | |
| K931565 | Merocel Wound Dressing | Merocel Corp. | KMF | Class I | |
| K931262 | Reusable/interchangeable Shaft, Endoscopic Scissor | T. Korossurgical Instruments Corp. | GCJ | Class II | |
| K930791 | American Power Conversions, Back-Ups 600 | Bio Clinic Co. | FMF | Class II | |
| K930626 | Sanitas Patient Scale | Dutton-Lainson Co. | FRW | Class I | |
| K930468 | 3M Incontinence Barrier Film, Product Series 336X | 3M Company | KMF | Class I | |
| K930345 | Tc2000 Power Unit and Accessories | Gaymar Industries, Inc. | DWJ | Class II | |
| K930339 | Reamer Bit | Neoligaments, Ltd. | HTW | Class I | |
| K930189 | Ortholoc(r) Advantim(tm) Posterior Stab Femor Comp | Dow Corning Wright | JWH | Class II | |
| K930153 | System III Halo Ring | Jerome Medical | JEC | Class II | |
| K930057 | Angestat Fluoro-Tip Hemostasis Introducer Set | B.Braun Medical, Inc. | DYB | Class II | |
| K926585 | Thorocoscopy Self-Retaining Retractor | T. Korossurgical Instruments Corp. | GAD | Class I | |
| K926583 | Reusable Endoscopic Scissors, Grasper-Monopolar | T. Korossurgical Instruments Corp. | GCJ | Class II | |
| K926380 | Alta Dressing Frame | Alta Medical Products, Inc. | KMF | Class I | |
| K926099 | Datascope 6000 Monitor | Datascope Corp. | MLC | Class II | |
| K924818 | Mobilaire V & III Pro2 Oxygen Sensors Features | Invacare GmbH | CAW | Class II | |
| K915494 | Nellcor Stat-Cap Airway CO2 Indicator, Model N-60 | Nellcor, Inc. | CCK | Class II | |
| K933180 | Quanta Lite Mitochondria M2 Elisa | Inova Diagnostics, Inc. | DGC | Class II | |
| K932957 | Quantem (Tm) | GE Healthcare | IYX | Class I | |
| K932745 | C-Equal(ceders-Emory Quantitive Analysis) | Philips North America LLC | KPS | Class II | |
| K932670 | Oticon Mf | Oticon, Inc. | ESD | Class I | |
| K932419 | Anti-Ss-B/la Antibody Test | Helix Diagnostics, Inc. | LLL | Class II | |
| K932402 | Modification to Ghajar Guide Twist Drill | Neurodynamics, Inc. | HBG | Class II | |
| K932251 | Rotator;male-Male, Male-Female | Merit Medical Systems, Inc. | DTR | Class II | |
| K931648 | Spectacle Frames | Eye Care Centers of America, Inc. | HQZ | Class I | |
| K931576 | Vista Ferritin Assay | Syva Co. | DBF | Class II | |
| K931574 | Advance Model Uds-Adv | Abbott Medical | EXQ | Class II | |
| K931275 | Mist Microsurgical Monopolar Forceps | Minimally Invasive Surgical Technologies, Inc. | GCJ | Class II | |
| K931274 | Mist Microsurgical Monopolar Scissors | Minimally Invasive Surgical Technologies, Inc. | GCJ | Class II | |
| K931123 | Digoxin Test System, Kxt Tx | Syva Co. | KXT | Class II | |
| K930890 | Cobas(r) Core Ige Total Eia | Roche Diagnostic Systems, Inc. | DGC | Class II | |
| K930529 | Benzodiazepine Enzyme Immunoassay | Diagnostic Reagents, Inc. | JXM | Class II | |
| K930454 | Boehringer Mannheim Coaguchek System | Boehringer Mannheim Corp. | JPA | Class II | |
| K930168 | Centricon -50 Concentrator | Amicon, Inc. | JJH | Class I | |
| K930112 | Maico Ma790 Audiometer | Maico Hearing Instruments, Inc. | EWO | Class II | |
| K926439 | Ma25 - Portable Audiometer, Modification | Maico Hearing Instruments, Inc. | EWO | Class II | |
| K926065 | Eyeglass Frames and Sunglasses | Palm Optical Co., Inc. | HQY | Class I | |
| K926039 | Guide-Tech Encapsulated Guidewire | Cape Tech Medical Products | KNY | Class II | |
| K924919 | Dade(r) Tumor Marker Control | Baxter Diagnostics, Inc. | JJY | Class I |