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 |
|---|---|---|---|---|---|
| K901433 | Sure-Flex Anastomotic Balloon Dilator | TeleMed Systems | FGE | Class II | |
| K901432 | Biliary Balloon Dilator | TeleMed Systems | FGE | Class II | |
| K901426 | Colonic Balloon Dilator | TeleMed Systems | FFP | Class I | |
| K901425 | Pyloric Balloon Dilator | TeleMed Systems | FAT | Class II | |
| K901424 | Esophageal Balloon Dilator | TeleMed Systems | KNQ | Class II | |
| K901347 | Datascope Slidewire(tm) | Datascope Corp. | DQX | Class II | |
| K897141 | Slot Staples and Adaptor for Zielke Spinal Fixatio | Stuart | JDN | Class II | |
| K896964 | Plasma Tfe Vascular Prosthesis Modified Instruc. | Medtronic, Inc. | DSY | Class II | |
| K902562 | Revised Labeling for Model Cl-0Pe Nd:yag Laser | Lca, Inc. | GEX | Class II | |
| K902555 | Amcath Coagulation Probe | Intl. Medical, Inc. | HFG | Class II | |
| K902168 | Arthroscopic Surgery Blades (Several Models) | Micro-Aire Surgical Instruments, Inc. | HRX | Class II | |
| K902028 | Statspin Illuminated Micro-Hematocrit Tube Reader | Norfolk Scientific, Inc. | JPI | Class II | |
| K902010 | Visi - Stick Ophthalmic Suture Retainer Tape | Visitec Co. | KGX | Class I | |
| K901934 | Kodak Surecell(tm) Chlamydia Control Fluid Set | Eastman Kodak Company | LJC | Class I | |
| K901808 | Micromate 196 Model A961960 | Packard Instrument Co., Inc. | JTC | Class I | |
| K901784 | Dryslide, Beta-Lactamase | Difco Laboratories, Inc. | JTO | Class I | |
| K901735 | Arthroscopic Surgery Blades Dy-3440, 3443, 3444 | Micro-Aire Surgical Instruments, Inc. | HRX | Class II | |
| K901616 | Cannulated Interference Screw System | Smith & Nephew Dyonics, Inc. | HWC | Class II | |
| K901571 | Sunglasses Style #(Cm-1989) | Zaks Stores, Inc. | HQY | Class I | |
| K901570 | Sunglasses Style #(1137) | Zaks Stores, Inc. | HQY | Class I | |
| K901531 | Pti Intra-Artr Reusable Coronary Artery Probe | Pioneering Technologies, Inc. | DNP | Class II | |
| K901481 | Model Yc-1200/Photocoagulator Ophthalmic Laser | Nidek, Inc. | GEX | Class II | |
| K901475 | Clinical Assays(tm) Gammacoat(tm) M [125I] T4 | Baxter Healthcare Corporation | CDX | Class II | |
| K901457 | Continuum Knee System (Cks) | Techmedica, Inc. | JWH | Class II | |
| K901397 | Accuprobe Listeria Monocytogenes Culture Confirma. | Hologic, Inc. | MCC | Class II | |
| K901336 | Asi Hemostasis Catheter | Advanced Surgical Intervention, Inc. | GBM | Class II | |
| K901134 | Entera-Flo Replacement Gastrostomy Tube | Fresenius Pharma | KNT | Class II | |
| K900764 | Sunglass, Non-Prescription | Seiko Optical Products of America, Inc. | HQY | Class I | |
| K900732 | Spectacle Frame | Seiko Corp. | HQZ | Class I | |
| K900482 | Software & Hardware Addition to Sentinel-4 EEG | Axon Systems, Inc. | GWF | Class II | |
| K902439 | Rx Rocker Triumph Wheelchair | The RX Rocker Corp. | IOR | Class I | |
| K902438 | Rx Rocker Wheelchair | The RX Rocker Corp. | IOR | Class I | |
| K902308 | Tamcenan Ocular Explants and Bands | Tamcenan Corp. | HQX | Class II | |
| K902230 | Colorado Color Imaging Recorder | Honeywell, Inc. | DSF | Class I | |
| K901572 | Sunglasses Style #(70116) | Zaks Stores, Inc. | HQY | Class I | |
| K901202 | Trojan Naturalamb Lubricated Natural Modified | Carter Products | HIS | Class II | |
| K901071 | Pulse Oximetry Module | Marquette Electronics, Inc. | DQA | Class II | |
| K902380 | Triflex Orthopedic Sterile Surgeon's Glove | Baxter Healthcare Corporation | KGO | Class I | |
| K902358 | Modified Delfia Estradiol Kit | Pharmacia, Inc. | CHP | Class I | |
| K902336 | Ciba Corning Acs:180 Automated Chemiluminescence | Ciba Corning Diagnostics Corp. | JJE | Class I | |
| K902259 | Axiom Total Knee System, Tibial Component | Orthomet, Inc. | JWX | Class I | |
| K902216 | Wako(tm) Micro-Albumin | FUJIFILM Healthcare Americas Corporation | JIQ | Class I | |
| K901809 | Lumiscope Electrodes Models El-08,11,15,06,21,25 | Lumiscope Co., Inc. | GXY | Class II | |
| K901729 | Saf-T Clik i.v. in-Line Connector & Extension Set | Ryan Medical, Inc. | FPA | Class II | |
| K901491 | Cuda Surgical Light | Cuda Products Co. | FST | Class II | |
| K901443 | Zimmon Papillotome | Wilson-Cook Medical Inc. | KNS | Class II | |
| K901437 | Transendoscopic Sclerotheraphy Needle | TeleMed Systems | FBK | Class II | |
| K901436 | Bronchial Cytology Brush | TeleMed Systems | FDX | Class II | |
| K901431 | Telemed Ercp Cannula | TeleMed Systems | FGE | Class II | |
| K901428 | Disposable Gastrointestinal Polypectomy Snare | TeleMed Systems | FDI | Class II |