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 |
|---|---|---|---|---|---|
| K134037 | Premvia | Biotime, Inc. | KGN | Unclassified | |
| K133695 | Titan 11 | Gemss Medical Systems Co., Ltd. | KPR | Class II | |
| K133538 | Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope Olympus Cyf Type Va2, Visera Cysto-Ne | OLYMPUS Corporation of the Americas | NWB | Class II | |
| K133168 | Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile | WRP Asia Pacific Sdn Bhd | LZA | Class I | |
| K132983 | Ton-95Lh, Pax-I3d Ortho | Vatech Co., Ltd. | OAS | Class II | |
| K131384 | Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid Bandage | Kericure, Inc. | KMF | Class I | |
| K141581 | Astroglide Natural | Biofilm, Inc. | NUC | Class II | |
| K141494 | Cd Horizon Spinal System | Medtronic Sofamor Danek USA Inc | NKB | Class II | |
| K141394 | X-Repair | Synthasome, Inc. | FTL | Class II | |
| K141336 | Source Guide Tube with Locking Mechanism for 113 Mm Needles, Gammamedplus | Varian Medical Systems, Inc. | JAQ | Class II | |
| K141327 | Minima S System | Lima Corporate S.p.A. | LZO | Class II | |
| K140999 | Tandemheart Veno-Venous Cannula | Cardiacassist, Inc. | DWF | Class II | |
| K140686 | Hevylite Human Igm Kappa and Lambda Kit for Use on Spaplus | The Binding Site Group Ltd. | PDE | Class II | |
| K140478 | Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | PHX | Class II | |
| K133991 | Isy | Altatec GmbH | DZE | Class II | |
| K133803 | Diazyme Glycated Serum Protein Poc Test Kit | Diazyme Laboratories, Inc. | LCP | Class II | |
| K133546 | Starlite-Om, Light Effects, Thibiant | Ps Advanced Engineering | OHS | Class II | |
| K133506 | Noras or Head Holder Flexibility | NORAS MRI products GmbH | MOS | Class II | |
| K133222 | Saad Patient Monitor (Spm) | Hanin Medical Services Co., Ltd. | MHX | Class II | |
| K131290 | Iq Technologies | IQ Technologies Inc. | NUH | Class II | |
| K141858 | Closurerfg Radiofrequency Generator | Medtronic, Inc. | GEI | Class II | |
| K141834 | Sapphire Administration Set | Q Core Medical, Ltd. | FPA | Class II | |
| K141822 | Sensei X Robotic Catheter System | Hanson Medical, Inc. | DXX | Class II | |
| K141818 | Turbo-Ject Picc Sets | Cook Corporated | LJS | Class II | |
| K141813 | Rhythmstar System | Rhythmedix | DXH | Class II | |
| K141056 | Triathlon Knee System Posterior Stabilized Components | Stryker Orthopaedics | MBH | Class II | |
| K140896 | Vapr Arctic Suction Electrode | DePuy Mitek, Inc. | GEI | Class II | |
| K140516 | Terumo Pen Injector Needle 34 | Kofu Factory of Terumo Corp. | FMI | Class II | |
| K140175 | Intravascular Administration Set | Delta Med SpA | FPA | Class II | |
| K133817 | Vitek 2 Ast - Yeast Fluconazole | bioMerieux, Inc. | NGZ | Class II | |
| K133108 | Fit Belt | Hong Qiangxing (Shenzhen) Electronics Limited | NGX | Class II | |
| K131348 | Ortomed | Infomed Servicios Informaticos S.L. | LLZ | Class II | |
| K123690 | Capnostream20p with Hifi C02 Monitoring | Oridion Medical 1987 Ltd. | CCK | Class II | |
| K141891 | Medical Lcd Monitor | Kostec Co., Ltd. | PGY | Class II | |
| K141768 | Logiq V5/logiq V3 | GE Healthcare | IYN | Class II | |
| K141746 | As20 Composite Graft | Wrightmedicaltechnologyinc | MQV | Class II | |
| K141592 | Unimicro Suction Irriation Tubing Set | Unimicro Medical Systems (Shenzhen) Co., Ltd. | GCJ | Class II | |
| K141496 | Multi-Parameter Mobile Careguide 4100 Oximeter | Reflectance Medical, Inc. | MUD | Class II | |
| K140880 | Devilbiss Smartlink II System | Sunrise Medical, Inc. | BZD | Class II | |
| K132211 | Skaffold Nmx Bone Void Filler | Skeletal Kinetics, LLC | MQV | Class II | |
| K131230 | Gmate Smart Blood Glucose Monitoring System, Gmate Smart Application | Philosys, Inc. | NBW | Class II | |
| K141859 | Cdc Human Influenza Virus Real-Time Rt-PCR Diagnostic Panel, Influenza A/h5 Subtyping | Centers for Disease Control and Prevention | OZE | Class II | |
| K141841 | Integra Mozaik Osteoconductive Scaffold - Strip | Integra Lifescience Corportation | MQV | Class II | |
| K141690 | Jusha-M33c Lcd Monitor | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K141684 | Jusha-C33c Lcd Monitor | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K141679 | Jusha-C61 Lcd Monitor | Nanjing Jusha Display Technology Co., Ltd | PGY | Class II | |
| K141610 | Futurabond M+ | Voco GmbH | KLE | Class II | |
| K141473 | Smc Acupuncture Needle | Smc Intl., Inc. | MQX | Class II | |
| K141353 | Hudson Rci Aquapak Humidifier Adaptor | Teleflexmedical, Inc. | BTT | Class II | |
| K141302 | Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa) | Canon Medical Informatics, Inc. | LLZ | Class II |