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 |
|---|---|---|---|---|---|
| K983826 | 3S Injector-CT Contrast Delivery System | Unimachs Corp. | DXT | Class II | |
| K000616 | Smartwedge Acl, Models 430623, 430628, 430723, 430728, 430823, 430828 | Bionx Implants, Inc. | MAI | Class II | |
| K000564 | Cordis Medium Palmaz Transhepatic Biliary Stent & Delivery | Cordis US Corp. | FGE | Class II | |
| K000306 | Pinnacle Acetabular System | Depuy Orthopaedics Inc. | LPH | Class II | |
| K000288 | Reichert Ct200 Contact Tonometer | Reichert Ophthalmic Instruments, Div. Leica, Inc. | HKY | Class II | |
| K000269 | Belleglass Hp Opaceous Dentin | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K994355 | Radiocameras System Head/neck Application | Surgical Navigation Technologies, Inc. | IYE | Class II | |
| K994353 | Secureline Disposable Fetal Monitoring Straps #3860 and #3565 | Precision Dynamics Corporation | HFM | Class II | |
| K994352 | Side Draft Neb-U-Mist Nebulizer, Model 41896 | Hudson Respiratory Care, Inc. | CAF | Class II | |
| K994351 | M.r. Vision 2000 Ultra Audio Visual System / Commander X6 System | Resonance Technology Inc | LNH | Class II | |
| K994339 | Hycure Oral / Hycure Oral Smart Gel | The Hymed Group Corp. | KGN | Unclassified | |
| K994226 | Sterichek Total Chlorine Reagent Strips | Environmental Test Systems, Inc. | MSY | Class II | |
| K994359 | Bond 1 C & B | Jeneric/Pentron, Inc. | KLE | Class II | |
| K994344 | Neurotherm RF Cannula | Rocket Medical | GXI | Class II | |
| K994317 | I-Plant, Model 3500 | Implant Sciences Corp. | KXK | Class II | |
| K994312 | Male Latex Condom 56Mm | Pleasure Latex Products Sdn. Bhd. | HIS | Class II | |
| K994311 | Male Latex Condom with Vanilla Flavor | Pleasure Latex Products Sdn. Bhd. | HIS | Class II | |
| K993953 | Oves Cervical Cap | Veos, Ltd. | HDR | Class II | |
| K992703 | Cardiotron EKG Multi-Phase Information Analysis System, Models 3800, 6800, 8800 | Premier Heart, LLC | DQK | Class II | |
| K000728 | Medtronic Solan Fiberoptic Corneal Light Probe | Medtronic Xomed, Inc. | FST | Class II | |
| K000576 | Elecsys Cortisol Calcheck | Roche Diagnostics GmbH | JIX | Class II | |
| K000529 | Lifestyle Mv2 (Tm) Toric (Polymacon) Soft (Hydrophilic) Multifocal Contact Lens for Daily Wear (Clear or Tinted) | The Lifestyle Co., Inc. | LPL | Class II | |
| K000376 | Specialty 42 (Hefilcon a) Hydrophilic Contact Lens for Daily Wear, Specialty T-42 Toric (Hefilcon a) Hydrophilic Contact | Specialty Ultravision, Inc. | LPL | Class II | |
| K000259 | Hardydisk, Ceftazidime, 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K000258 | Hardydisk, Ciprofloxacin, 5Mcg | Hardy Diagnostics | JTN | Class II | |
| K000239 | Glypro Reagent, Glypro Calibrator, Glypro Low Control, Glypro High Control | Genzyme Corporation | LCP | Class II | |
| K000229 | Videolabs Medcam Proplus Video Camera and Integral Light Source | Videolabs, Inc. | FCW | Class II | |
| K000203 | Hardydisk, Kanamycin, 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K000040 | Invigra Male Latex Condom Blue Colored and Vanilla Flavored | Indus Medicare, Ltd. | HIS | Class II | |
| K000039 | Invigra Male Latex Condom Yellow Colored and Banana Flavored | Indus Medicare, Ltd. | HIS | Class II | |
| K000038 | Invigra Male Latex Condom Green Colored and Mint Flavored | Indus Medicare, Ltd. | HIS | Class II | |
| K994335 | Prosoft (Phemfilcon) Soft (Hydrophilic) Contact Lens | Wesley Jessen Corp. | LPL | Class II | |
| K994319 | Modulap | Atc Technologies Inc. | GEI | Class II | |
| K994306 | Reverso | Medisystems Corp. | KOC | Class II | |
| K994290 | Bard Endoscopic Suturing System | C.R. Bard Inc | ODE | Class II | |
| K993737 | Mighty Man (Dynamic Linkers) | MedTech Products, Inc. | HIS | Class II | |
| K993735 | Double Springers | MedTech Products, Inc. | HIS | Class II | |
| K993733 | Love Lockers | MedTech Products, Inc. | HIS | Class II | |
| K993357 | Iolmaster | Carl Zeiss, Inc. | HJO | Class II | |
| K993343 | Erecxel Adjustable Penile Bands, Contrex Adjustable Penile Bands | Erecxel Enterprises | LKY | Class II | |
| K993225 | Bladeworks Microkeratome Blade | Blade Works, Inc. | HNO | Class I | |
| K992530 | BIPAP Synchrony Hc | Respironics, Inc. | MNS | Class II | |
| K992180 | Visage Cosmetic Surgery, Model V5000 | ArthroCare Corporation | GEI | Class II | |
| K991840 | Fresco Phosphene Tonometer and or Phosphene Tonometer and or Fpt and or Eyelid Tonometer | Bernard B. Fresco | HKY | Class II | |
| K000716 | Access Ck-Mb on the Access Immunoassay Analyzer | Siemens Healthcare Diagnostics Inc. | JHX | Class II | |
| K000635 | Modification to Hp M2376a Device Link System | Agilent Technologies, Inc. | MWI | Class II | |
| K000488 | Vital Shield Gold Non-Sterile Powdered Latex Exam Gloves Blue, with And/or without Bubblegum Scent, and with Protein Lab | Sgmp Co., Ltd. | LYY | Class I | |
| K000439 | Durasoft 2 (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 2 (Phemfilcon a) Sherical ( Hydrophilic)c | Wesley Jessen Corp. | LPL | Class II | |
| K000103 | Avl Opti R Analyzer | Avl Scientific Corp. | CHL | Class II | |
| K000057 | Radionics Lumboperitoneal Shunt | Radionics, Inc. | JXG | Class II |