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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K890784 | Mammomat C | Siemens Medical Solutions USA, Inc. | IZH | Class II | |
| K890519 | Labsonics Mamm-O-Mate Model No. 918084-1 | Laboratory Equipment Corp. | IYO | Class II | |
| K890334 | Total Cholesterol Reagent | Alpkem Corp. | CHH | Class I | |
| K884161 | Acromed Iliac Screw | Buckman Co., Inc. | KWP | Class II | |
| K892260 | Prichard Periosteal Retractor #3 | Zinnanti Surgical Instruments, Inc. | EKJ | Class I | |
| K891978 | Patient Examination Glove (Latex) | Latex Supply Products (HP), Inc. | LYY | Class I | |
| K891977 | Patient Examination Gloves (Latex) | Grandclass, Ltd. | LYY | Class I | |
| K891976 | Patient Examination Gloves (Latex) | Ever Surplus (USA), Inc. | LYY | Class I | |
| K891599 | Filaflex Orthodontic Wire | American Orthodontics | EJF | Class I | |
| K891472 | Implant Technology Bone Cement Extractor | Implant Technology, Inc. | LZV | Class II | |
| K890998 | Qad Angiodynograph Ultrasound: Color Doppler Eval. | Quantum Medical Systems, Inc. | IYN | Class II | |
| K890791 | Siemens Sirecust 730 Patient Monitor | Siemens Medical Electronics | DPS | Class II | |
| K890681 | Orosphere Hcdp | Jeneric/Pentron, Inc. | EJJ | Class II | |
| K892521 | Cymed Microskin(r) Disposable Irrigation Sleeve | Cymed, Inc. | FZS | Class I | |
| K892346 | Slt Contact Laser Systems (Gynecology) | Surgical Laser Technologies, Inc. | GEX | Class II | |
| K892255 | Dental Root Elevator | Zinnanti Surgical Instruments, Inc. | EKO | Class II | |
| K892030 | Patient Exam Gloves (Mfg. Tan Chong Rubber Gloves) | Behn Meyer & Co. (M) Sdn Bhd | LYY | Class I | |
| K892011 | Patient Examination Gloves (Latex) | Mediglove Sdn. Bhd. | LYY | Class I | |
| K891768 | Genetic Systems Microplate Washer | Genetic Systems Corp. | JTC | Class I | |
| K891766 | Genetic Systems Microplate Strip Washer | Genetic Systems Corp. | JTC | Class I | |
| K891765 | Genetic Systems Pipettor/dilutor | Genetic Systems Corp. | JTC | Class I | |
| K891735 | Patient Examination Gloves (Latex) | Harry Panzer Intl. Corp. | LYY | Class I | |
| K891617 | Insertion Tools | Implant Innovations International, Inc. | DZE | Class II | |
| K891269 | Microtrak Eia Autowasher | Syva Co. | JYC | Class I | |
| K891142 | General Electric Amx II | Pro-Tronics, Inc. | IZL | Class II | |
| K891140 | Occlu-Seal(tm) Visible Light-Cured Fissure Sealant | Coe Laboratories, Inc. | EBC | Class II | |
| K891054 | Non-Sterile Gauze Sponge | Dispomed, Inc. | KHR | Class I | |
| K890980 | Modified Stockert-Shiley Venous Catheter | Shiley, Inc. | DWF | Class II | |
| K890855 | Model 4041; 4 Angled Pair Crc Surface Coil | Medical Advances, Inc. | LNH | Class II | |
| K890834 | No-Mix 30 Orthodontic Bonding System, Plastic | Scientific Pharmaceuticals, Inc. | DYH | Class II | |
| K890830 | Denture Resin | G-C Intl. Corp. | EBI | Class II | |
| K890808 | Sarns Membrane Oxygenator W/integral Cardio Reserv | 3M Company | DTZ | Class II | |
| K890679 | Scalp Vein Set | Ashley Health Care, Inc. | FPA | Class II | |
| K890655 | New Freedom Thin Deodorant Maxi Pads | Kimberly-Clark Corporation | HHL | Class II | |
| K890536 | Jasper Jumper Kit | American Orthodontics | EJF | Class I | |
| K890143 | Acutron Multiwave for Use in Tmj Syndrome Pain Con | Microcurrent Research, Inc. | NUW | Class II | |
| K885343 | Standex | Alt, Inc. | ION | Class I | |
| K885166 | Zmi Part No. Ntp-2100, Pediatric Electrodes | Zmi Corp. | DRO | Class II | |
| K885066 | Hematome System | Surgical Dynamics Ltd | GET | Class I | |
| K884980 | F56 K Karaya Gum Disp. Pe-Foam ECG Electrode, 56Mm | S & W Medico Teknik | DRX | Class II | |
| K880343 | Burney Gallbladder Catheter Kit | Mallinckrodt Critical Care | FGE | Class II | |
| K892322 | Patient Examination Gloves (Latex) | Golden Bonanza Industrial Corp. | LYY | Class I | |
| K892303 | Non-Sterile Patient Examination Gloves | Starlit Ent. Co., Ltd. | LYY | Class I | |
| K892302 | Non-Sterile Patient Examination Gloves | Yeou-Fwu Rubber Industrial Co., Ltd. | LYY | Class I | |
| K892299 | Patient Examination Gloves (Latex) | Tegas Setia Sdn Bhd | LYY | Class I | |
| K892292 | Patient Exam Gloves (Mfg. Multi-Com Sdn Bhd) | American Health Products, Inc. | LYY | Class I | |
| K892276 | Patient Examination Gloves (Latex) | United Supply Co., Inc. | LYY | Class I | |
| K892233 | Auto Suture(r) Endoscopic Gia(tm) Surgical Stapler | United States Surgical, A Division of Tyco Healthc | GDW | Class II | |
| K892134 | Patient Examination Gloves (Latex) | Steril Rubber Sdn. Bhd. | LYY | Class I | |
| K892133 | Patient Examination Gloves (Latex) | Limattan Corp. | LYY | Class I |