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 |
|---|---|---|---|---|---|
| K143386 | Progrip Laparoscopic Self-Fixating Mesh | Sofradim Production | FTL | Class II | |
| K143379 | Liquichek Maternal Serum II Control | Bio-Rad Laboratories Inc. | JJY | Class I | |
| K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector) | Dutch Ophthalmic Research Center International BV | HQC | Class II | |
| K142206 | Dental Unit | Zhuhai Siger Medical Equipment Co Ltd | EIA | Class I | |
| K141944 | Home Access Aic Test | Home Access Health Corp. | LCP | Class II | |
| K141665 | NuVasive CoRoent System | NuVasive Inc | MAX | Class II | |
| K141237 | Harmony Lite | Alma, Inc. | ONF | Class II | |
| K143662 | Bissinger Monopolar Forceps and Cables | Medagent Inc | GEI | Class II | |
| K143598 | Lapro-Clip Auto Suture Reusable Long Clip Applier | Medtronic, Inc. | FZP | Class II | |
| K142873 | OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners | C.R. Bard Inc | GDW | Class II | |
| K142801 | Triton Canister System | Gauss Surgical, Inc. | PBZ | Class II | |
| K142766 | I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear | Interojo Inc. | LPL | Class II | |
| K142634 | Biomet Spine Fusion System | Highridge Medical, LLC | MAX | Class II | |
| K142352 | CardiacLinx | Ross Medical Technology, Inc. | DSI | Class II | |
| K141524 | Neuro-Audio | Teleemg, LLC USA | EWO | Class II | |
| K150375 | LIAISON VZV IgG, LIAISON Control VZV IgG | Diasorin Inc. | LFY | Class II | |
| K143316 | Attain Hybrid Guide Wire | Medtronic, Inc. | DQX | Class II | |
| K142736 | XIDF-AWS801, Angio Workstation, v5.31 | Toshibamedical Systems Corporation | OWB | Class II | |
| K141837 | Drx-Evolution | Eastman Kodak Company | KPR | Class II | |
| K141159 | Konus Dental Implant System | Argon Med. Productions Vertriebs Gesellschaft mbH | DZE | Class II | |
| K133838 | Sterilization Pouch/roll Made with Tyvek | Sigma Medical Supplies Corp. | FRG | Class II | |
| K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | NPJ | Class II | |
| K143753 | Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio | Rayence Co., Ltd. | MUH | Class II | |
| K143519 | The MeDioStar NeXT Family | Asclepion Laser Technologies GmbH | GEX | Class II | |
| K143414 | Hill-Rom Wireless Connectivity Module | Hill-Rom Inc. | IOQ | Class II | |
| K143318 | DR Systems Zero Download 3D Viewer (Z3D) | Dr Systems, Inc. | LLZ | Class II | |
| K143114 | Sense4Baby System Model B+ (MSA) | AirStrip Technologies, Inc. | LQK | Class II | |
| K142465 | Aquilion ONE Vision, v7.0 | Toshibamedical Systems Corporation | JAK | Class II | |
| K142439 | Martinez Prostate Template Set | Nucletron BV | JAQ | Class II | |
| K142068 | Bulldog Biopsy Valve, Olympus and Fujinon;pentax Compatible;disposable Rrigating Adaptor, Sterile and Non-Sterile | Medovations, Inc. | OCX | Class II | |
| K141624 | Plastic Needle with Mandrin, 2.0 Mm Diameter, Length, Blunt Tip,plastic Needle with Mandrin, 2.0 Mm Diameter, Length 113 | Varian Medical Systems, Inc. | JAQ | Class II | |
| K150275 | Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls | Immunalysis Corporation | DJG | Class II | |
| K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | Schoelly Fiberoptic, GmbH | HIH | Class II | |
| K142808 | CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners | C.R. Bard Inc | GDW | Class II | |
| K142782 | KIMGUARD ONE-STEP Sterilization Wrap | Kimberly-Clark Health Care | FRG | Class II | |
| K141981 | Asahi Fubuki 043 / Asahi Fubuki | Asahi Intecc Co., Ltd. | DQY | Class II | |
| K141767 | Id Millennium, Id Moments Silicone | WESTRIDGE LABORATORIES, Inc | NUC | Class II | |
| K141717 | Pacseal Pit & Fissure Sealant | Pac-Dent International, Inc. | EBC | Class II | |
| K150322 | InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) | Pan Medical, Ltd. | NDN | Class II | |
| K143537 | Sirius Starmobile tiara | FUJIFILM Healthcare Americas Corporation | IZL | Class II | |
| K143419 | Patient Examination Gloves | Hartalega NGC Sdn Bhd | LYY | Class I | |
| K143389 | 3.0T GEM RT Open Array | GE Healthcare Coils (USA Instruments, Inc.) | MOS | Class II | |
| K143109 | Xp300 | BTL Industries, Inc | GEI | Class II | |
| K142341 | X-Ray Tv System Sonialvision G4 | Shimadzu Corp. | JAA | Class II | |
| K141793 | Pulmone Miniboxpft 2.0 | Pulmone Advanced Medical Devices, Ltd. | BZG | Class II | |
| K141790 | Aqanife | Ovesco Endoscopy AG | GEI | Class II | |
| K141536 | Viewing Client Mobile | Axon Medical Technologies Corp. | LLZ | Class II | |
| DEN130046 | Reza Band(tm) Upper Esophageal (Ues) Sphincter Assist Device | Somna Therapeutics, LLC | PKA | Class II | |
| K150285 | Leva(TM) Spacer System | Spine Wave Inc | MAX | Class II | |
| K150258 | Vitrea, Version 7.0 Medical Image Processing Software | Canon Medical Informatics, Inc. | LLZ | Class II |