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 |
|---|---|---|---|---|---|
| K090839 | Modification to Syntec-Taichun Non-Sterile Bone Plate and Screw Implants | Syntec Scientific Corp. | HRS | Class II | |
| K090816 | Stryker Spine Avs Pl Peek Spacers | Stryker Corp. | MAX | Class II | |
| K090666 | Pediplates | Orthopediatrics Corp | HRS | Class II | |
| K090299 | Biolox Option Ceramic Femoral Head and Metha Xl Heads | Aesculap Inc | LZO | Class II | |
| K090192 | Bili Blue F20t12/bby and F40t12/bby | Interlectric Corp. | LBI | Class II | |
| K090185 | Clever Chek Blood Glucose Monitoring System; Achtung Blood Glucose Monitoring System | Taidoc Technology Corporation | NBW | Class II | |
| K090178 | Attrius, Model Pet150a6001, Attrius L, Model Pet150a8001, Truesight, Model Nsp-P6c, Truesight, Model Nsp-P8 | Neusoft Positron Medical Systems Co.,Ltd. | KPS | Class II | |
| K090138 | Mobilecare Monitor, Model 2100 | Aframe Digital, Inc. | KMI | Class I | |
| K083509 | Lifeglobal Human Serum Albumin Lg Hsa | <Genx> Intl., Inc. | MQL | Class II | |
| K083351 | Proable Pulse Oximeter, Model Md-600P, Traveler Oximeter, Model Md-650P and Palm Pulse Oximeter, Model Md-680P | Comdek Industrial Corp. | DQA | Class II | |
| K082908 | Novaguard, Model 3611001 | West Pharmaceutical Services, Inc. | FMI | Class II | |
| K082479 | Sklar Surgical Gown | Sklar Corp. | FYA | Class II | |
| K090695 | Dinkler Surgical Skull Clamp, Model 0308 | Dinkler Surgical Devices, Inc. | HBL | Class II | |
| K090464 | Black Nitrile Examination Gloves, Powder Free, Non Sterile | Pt Mahakarya Inti Buana | LZA | Class I | |
| K090217 | Bonee Needle for Bladder Injections, Modelsnbi035, Nbi070 | MEDLINE INDUSTRIES, LP - Northfield | FBK | Class II | |
| K090053 | Aptus 2.0 Radial Head System | Medartis AG | HRS | Class II | |
| K083889 | Fotona Qx Nd:yag/ktp Laser System Family | Fotona D.D. | GEX | Class II | |
| K083630 | Clue Medical and Clue Medical Basic | Telovital GmbH Telemedizin | DXH | Class II | |
| K083467 | Rebound Hrdv | Minnesota Medical Development, Inc. | FTL | Class II | |
| K082934 | Extremity Medical Midfoot Screw System | Extremity Medical, LLC | HWC | Class II | |
| K080978 | Walgreen's Personal Lubricating Jelly | Topco Sales | NUC | Class II | |
| K091137 | Ultimum/engage/engage Tr | Abbott Medical | DYB | Class II | |
| K091087 | Modification to V-Loc 180 Absorbable Wound Closure Device | Surgical Devices, Tyco Healthcare Group LP | GAM | Class II | |
| K091011 | Pureform Eptfe Facial Implants (Nasal, Chin, Maler) | Surgical Technology Laboratories, Inc ("Stl") | FWP | Class II | |
| K090799 | Modification to Expedium Spine System | DePuy Spine, Inc. | NKB | Class II | |
| K090782 | Novel Alif Spinal Spacer System | Alphatec Spine, Inc. | MAX | Class II | |
| K090607 | Blue Sky Bio Plan, Version .38 | Blue Sky Bio, LLC | LLZ | Class II | |
| K090603 | Barco 5Mp Mammo, Model Mdmg-5221 | Barco N.V. | LLZ | Class II | |
| K090366 | Spec Model M-31 | Source Production and Equipment Co., Inc. | KXK | Class II | |
| K090166 | Avs Anterior Large Peek Spacers | Stryker Corp. | MAX | Class II | |
| K090147 | Blood Monitoring Unit, Model Bmu 40 | MAQUET CARDIOPULMONARY GmbH | DRY | Class II | |
| K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, Ec-450B15 | FUJIFILM Healthcare Americas Corporation | FDF | Class II | |
| K090074 | Hygia Health Services Reprocessed Compression Sleeves / Foot Cuffs | Hygia Health Services, Inc. | JOW | Class II | |
| K090070 | Invuity Britefield Mcculloch Retractor System | Invuity, Inc. | FST | Class II | |
| K090063 | Merete Locking Bone Plate System | Merete GmbH | KTT | Class II | |
| K090058 | Ya Horng Digital Upper Arm Blood Pressure Monitor, Bp-700, Bp-700T, Bp700u, Bp-700B, Bp-700Tb, Bp-700Ub, Bp-700Tub | Ya Horng Electronic Co., Ltd. | DXN | Class II | |
| K083656 | Apex Medical Xt Auto CPAP 9S-005200 | Apex Medical, Inc. | BZD | Class II | |
| K083512 | Fluid-Filled Teether | Wiltec Industries, Ltd. | KKO | Class II | |
| K083374 | Wallflex Biliary Rx Partially-Covered Stent System | Boston Scientific Corporation | FGE | Class II | |
| K090992 | Well-Paste | Vericom Co., Ltd. | KIF | Class II | |
| K090872 | Modification to Cardica C-Port Xa Distal Anastomosis System | Cardica, Inc. | FZP | Class II | |
| K090764 | Novation Cfs Press-Fit and Cemented Stems | Exactech, Inc. | LWJ | Class II | |
| K090134 | Intravenous Power Injector Extension Set | C.R. Bard Inc | FPA | Class II | |
| K090013 | Chempaq Xbc Analyzer | Chempaq A/S | GKZ | Class II | |
| K083794 | Mecc Set with Bioline Coating | MAQUET CARDIOPULMONARY GmbH | KFM | Class II | |
| K083554 | Cliniqa Liquidqc Immunoassay Control Level 1, 2 & 3 | Cliniqa Corporation | JJY | Class I | |
| K083350 | Tens/nmes/fes Stimulating Electrode | Medtronic, Inc. | GXY | Class II | |
| K082698 | Aleutian Ibf System | K2M, Inc | MAX | Class II | |
| K082325 | Apexum Ablator | Apexum, Ltd. | EKX | Class I | |
| K082223 | Neutrolumenpn System, Model 1000 | Neurolumen LLC | ILY | Class II |