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 |
|---|---|---|---|---|---|
| K910653 | Touchless II Intermittent Catheter | C.R. Bard Inc | FCM | Class II | |
| K910564 | Versacath(tm0 Mainline(tm) with Introduction Tray | Menlo Care, Inc. | FOZ | Class II | |
| K910515 | Freedom Mark III Surgical Helmet System | Stackhouse Assoc. | FYA | Class II | |
| K910500 | Howmedica Kinemax Plus Total Knee System | Howmedica Corp. | JWH | Class II | |
| K910496 | Carbon Dioxide Laser Systems W/arthoguide CO2 Del. | Heraeus Lasersonics, Inc. | GEX | Class II | |
| K910067 | Pti Sternal Closure Wire Suture | Pioneering Technologies, Inc. | GAQ | Class II | |
| K905782 | Fht (Fecal Heme Test) | Aerscher, Inc. | KHE | Class II | |
| K905480 | Spiroscope | Grandcor Medical Systems | BZC | Class II | |
| K905038 | Olympus Pk-Tp Absorbent Kit | Fujirebio America, Inc. | GMT | Class II | |
| K903394 | Globalcare Micro 11 and Microcare (TENS) | Globalcare Intl., Inc. | GZJ | Class II | |
| K911774 | Aladan Latex Medical Glove | Aladan Corp. | LYY | Class I | |
| K911037 | Safety Needle Sheath, Modification | Concord/Portex | FMI | Class II | |
| K910971 | Z Xt Radiation Therapy Treatment Table | Siemens Medical Laboratories, Inc. | JAI | Class II | |
| K910911 | Moss P.e.g. Tray | Moss Medical Products | KNT | Class II | |
| K910847 | Ohmeda 7810 Anesthesia Ventilator | GE Healthcare | CBK | Class II | |
| K910790 | Mentor Lubricating Jelly | Mentor | KMJ | Class I | |
| K910241 | Statim Cassette Autoclave | Scican Ltd. | FLE | Class II | |
| K905635 | Ohmeda Modulus Cd Anesthesia System | GE Healthcare | BSZ | Class II | |
| K905235 | Vdr Sinusoidal Percusionator Family/relate Access | Percussionaire Corp. | CBK | Class II | |
| K901932 | Varian Electronic Portal Imaging System | Varian Assoc., Inc. | IYE | Class II | |
| K911160 | Mentor(r) Wet-Field(r) II Ac Coagulator, 22-1305 | Mentor O & O, Inc. | GEI | Class II | |
| K910964 | Hot Biopsy Forceps | Boston Scientific Corporation | KGE | Class II | |
| K910661 | Model 205 Shock-Trode | Cardiotronics, Inc. | DRO | Class II | |
| K911292 | Schneider Wallstent(r) | Pfizer Hospital Products Group, Inc. | FGE | Class II | |
| K911178 | Acs Therapeutic Drug Monitoring Control, Level III | Analytical Control Systems | JJX | Class I | |
| K911177 | Acs Therapeutic Drug Monitoring Control, Level II | Analytical Control Systems | JJX | Class I | |
| K911176 | Acs Therapeutic Drug Monitoring Control, Level I | Analytical Control Systems | JJX | Class I | |
| K911171 | Acs Therapeutic Drug Monit Contr, Set II Level III | Analytical Control Systems | JJY | Class I | |
| K911170 | Therapeutic Drug Monit Control, Set II, Level II | Analytical Control Systems | JIY | Class I | |
| K911169 | Acs Therapeutic Drug Monit Contr, Set II, Level I | Analytical Control Systems | JJY | Class I | |
| K911168 | Acs Therapeutic Drug Monit Contr, Set I, Level III | Analytical Control Systems | DIF | Class I | |
| K911167 | Acs Therapeutic Drug Monit Contr, Set I, Level II | Analytical Control Systems | DIF | Class I | |
| K911109 | Ophta Sil (R), Lachrymal Intubation Sets | G.W.B. Intl., Ltd. | OKS | Unclassified | |
| K911082 | Real Time X-Ray Imaging System | Siemens Medical Solutions USA, Inc. | LMA | Class II | |
| K910930 | Acs Therapeutic Drug Monitoring Control Set I Le.1 | Analytical Control Systems | DIF | Class I | |
| K910737 | Sri T3 Immoenzymetric Assay | Serono-Baker Diagnostics, Inc. | CDP | Class II | |
| K910684 | Ciba Corning Acs Ft4 Immunoassay | Ciba Corning Diagnostics Corp. | CEC | Class II | |
| K910499 | Immunodiagnostic Assay System Herpes Simplex Virus | Vitek Systems, Inc. | LGC | Class II | |
| K910432 | Hapset Hydroxylapatite Bone Graft Plaster | Lifecore Biomedical LLC | LYC | Class II | |
| K910415 | Sunglasses | K.M Optical Co. | HQY | Class I | |
| K910320 | Serim Peracetic Acid Reagent Strips | Serim Research Corp. | JOJ | Class II | |
| K910317 | Uni-Sem(tm) | Unimar, Inc. | MFD | Class II | |
| K904344 | Sleeper Mask System | Devilbiss Health Care, Inc. | BZD | Class II | |
| K904332 | Mstim-2000 Ems | Oms Medical Supplies, Inc. | IPF | Class II | |
| K910981 | Ciba Corning Acs Tsh Immunoassay | Ciba Corning Diagnostics Corp. | JLW | Class II | |
| K910467 | Argiplus | Argen Precious Metals, Inc. | EJS | Class II | |
| K910158 | Amylase | Horiba Instruments Incorporated | JFJ | Class II | |
| K905704 | Ma630 Imped Screener/ma640 Imped/audiomet Screener | Maico Hearing Instruments, Inc. | ETY | Class II | |
| K905392 | Ht4-Series Hysteroscopes and Accessories | Frigitronics, Inc. | HIH | Class II | |
| K904659 | Dr. Dedo's Family Ear Examination Kit | Panex Corp. | ERA | Class I |