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 |
|---|---|---|---|---|---|
| K050393 | The Guided Surgery Concept | Nobel Biocare AB | DZE | Class II | |
| K050171 | It Nasal Mask | Innomed Technologies | BZD | Class II | |
| K050060 | Laguna Pedicle Screw System | Allez Spine, LLC | MNI | Class II | |
| K043125 | Orion Diagnostica Uniq Pinp Ria | Orion Diagnostica, Inc. | CIN | Class II | |
| K043073 | Procotyl-E Acetabular System | Wrightmedicaltechnologyinc | KWA | Class III | |
| K042595 | Spiro'air | Morgan Scientific, Inc. | BZG | Class II | |
| K040916 | Vitalcare Powder Free Synthetic Vinyl Examination Glove | Vitalcare Group, Inc. | LYZ | Class I | |
| K040145 | Ata Hcm Monoplace Hyperbaric System | Ata Hyperbaric Chamber Manufacturing | CBF | Class II | |
| K051077 | E-Type Straight Handpiece, Model Ahp-101 | Aseptico, Inc. | EGS | Class I | |
| K050605 | Spacelabs Medical Multiparameter Module 91496 | GE Healthcare | DSI | Class II | |
| K043005 | Modification to Mbcp | Biomatlante | MQV | Class II | |
| K041184 | Nti Tension Suppression System, with a Snorehook Application | Nti-Tss, Inc. | LRK | Class II | |
| K041161 | Microcyn Wound Care Dressing | Sonoma Pharmaceuticals, Inc. | FRO | Unclassified | |
| K051010 | Securalloy, Septalloy Ng 50 and Septalloy Ng 70 | Septodont | EJJ | Class II | |
| K050990 | Remrest Heated Humidifier | Medical Industries America, Inc. | BTT | Class II | |
| K050872 | Accu-Chek Integra System | Roche Diagnostics GmbH | LFR | Class II | |
| K050672 | Erchonia Evrl Laser | Erchonia Medical, Inc. | GEX | Class II | |
| K050665 | N Antisera to Human Complement Factors (C3c, C4) | Siemens Healthcare Diagnostics Inc. | CZW | Class II | |
| K050661 | Hemosil Factor II Deficient Plasma | Instrumentation Laboratory Co. | GJT | Class II | |
| K050656 | Amsino Suture Removal Kit | Amsino International, Inc. | MCZ | Class I | |
| K050654 | Amsino i.v. Start Kit | Amsino International, Inc. | LRS | Class II | |
| K050521 | Embryo Transfer Catheter with Accessory Stylet, Models 9018, 9023, 9018-S, 9023-S | Inntec, Inc. | MQF | Class II | |
| K050495 | Easyspray and Spray Set for Tisseel (Fiber Sealant) | Baxter Healthcare Corp., Bioscience | FMF | Class II | |
| K043084 | Premere Delivery Sheath, Model Pds | Velocimed, Inc. | DYB | Class II | |
| K050974 | Draeger Medical Information Bus (Mib, Mib II, Mib Duo) Protocol Converters | Draeger Medical Systems, Inc. | DRQ | Class II | |
| K050972 | Vision-Sciences ENT-3000 Scope | Cogentix Medical, Inc. | EOB | Class II | |
| K050950 | Models Crystal 512, Record 618, Optima 518 Photo Epilation Systems | Active Optical Systems, Ltd./Efraim Bidas | GEX | Class II | |
| K050833 | Electrode Junction Box, Model Je-921A | Nihon Kohden America Inc | OLV | Class II | |
| K050747 | Bd Phoenix Automated Microbiology System, Levofloxacin (Strep) 0.25-16 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K050745 | Bd Phoenix Automated Microbiology System, Vancomycin (Strep) 0.0625 -32 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K050682 | Liquichek Urine Toxicology Control (Level C1) | Bio-Rad Laboratories Inc. | DIF | Class I | |
| K050540 | Ucp Rapid Drug Screening Tests | Ucp Biosciences, Inc. | DKZ | Class II | |
| K050496 | Rem440 | Interacoustics A/S, Assens | ETW | Class II | |
| K050369 | Intuitive Surgical Da Vinci Surgical System, Model Is2000 | Intuitive Surgical, Inc. | NAY | Class II | |
| K050350 | The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview Php) | Notal Vision Ltd. | HPT | Class I | |
| K050274 | Diodent II Dental Laser System | Hoya Photonics, Inc. | GEX | Class II | |
| K043604 | Lifeshirt Real-Time with Vivomonitor Software | Vivometrics, Inc. | DQK | Class II | |
| K043245 | Eps Easy Pain Supreme Self Monitoring Blood Glucose System | Eps Bio Technology Corp. | CGA | Class II | |
| K042118 | Athena Multi-Lyte Ebv Igg Test System | Zeus Scientific LLC | JRY | Class I | |
| K040501 | Dbx Demineralized Bone Matrix Putty, Paste and Mix | Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | NUN | Class II | |
| K040120 | Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays | Diasorin Inc. | LLM | Class I | |
| K050794 | Angiojet Dvx Rheolytic Thrombectomy Catheter | Possis Medical, Inc. | QEZ | Class II | |
| K050768 | Zilos-Tk, Version 3, Zilos-Tk, Version 4 | Hamilton Thorne Biosciences | MRX | Class II | |
| K050401 | Ceramage | Shofu Dental Corp. | EBF | Class II | |
| K043156 | D-Carie, Model N121-M1 | Neks Technologies, Inc. | NBL | Class II | |
| K042989 | Rx90 Low Profile Acetabular System | Zimmer GmbH | LPH | Class II | |
| K041648 | Niti-S Stent & Introducer, Model Eoxxxx | Taewoong Medical Co., Ltd. | ESW | Class II | |
| K041539 | Compel Surgical Gowns | Standard Textile Co., Inc. | FYA | Class II | |
| K051013 | Spinemed S200b/s200c | Cert Health Sciences, LLC | ITH | Class II | |
| K050987 | Digital Radiography Model Cxdi-40Eg | Canon, Inc. | MQB | Class II |