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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K230394 | Euroscrew Ng; Euroscrew Tcp Ng | Teknimed SAS | MAI | Class II | |
| K223706 | Pmma Block | Huliang (shanghai) Bio-Tech Co., Ltd. | EBG | Class II | |
| K223101 | BD Secondary Infusion Set | Care Fusion | FPA | Class II | |
| K222854 | iTFlow | Cardio Flow Design Inc. | LLZ | Class II | |
| K222489 | Harvest Printable Resin | Harvest Dental Products LLC | EBI | Class II | |
| K222460 | Intraoperative Ultrasound Probe Cover | Exact Medical Manufacturing, Inc. | ITX | Class II | |
| K222106 | Waypoint GPS | Waypoint Orthopedics | QWP | Class II | |
| K221969 | IU Implant System Abutment | WARANTEC Co., Ltd. | NHA | Class II | |
| K231052 | ExacTrac Dynamic 1.1.2 | Brainlab, Inc. | IYE | Class II | |
| K230550 | JAWS Nitinol Staple System | Paragon 28 | JDR | Class II | |
| K230280 | ANDORATE® Suction Valve and ANDORATE® Biopsy Valve | GA Health Company Limited | KTI | Class II | |
| K223623 | SubtleMR (2.3.x) | Subtle Medical Inc | LLZ | Class II | |
| K223265 | CryoX Vitrification Freeze Kit / Thaw Kit | Zhejiang Horizon Medical Technology Co., Ltd. | MQL | Class II | |
| K222549 | OpenTex | Purgo Biologics Inc. | NPK | Class II | |
| K222501 | Regeneten Bioinductive Implant | Smith & Nephew, Inc. | OWY | Class II | |
| K220721 | FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | |
| K231338 | 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment | 3M ESPE Dental Products | LBH | Class II | |
| K231032 | AMP by Method Mobility, AMP Plus (or +) by Method Mobility | Method Mobility, Inc. | ITI | Class II | |
| K230491 | HandX™ Monopolar Scissors | Human Xtensions, Ltd. | GCJ | Class II | |
| K223624 | Emerald Herbst | Island Dental Lab, Inc dba Emerald Dental | LRK | Class II | |
| K223318 | Internal Joint Stabilizer - Elbow | Skeletal Dynamics, Inc | OZI | Class II | |
| K223044 | Digital Thermometer (Model QT001) | Shen Zhen Rong Feng Technology Co., Ltd. | FLL | Class II | |
| K222987 | Akunah REFLECT | Akunah | LLZ | Class II | |
| K222870 | Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 | Shenzhen Kentro Medical Electronics Co., Ltd | NUH | Class II | |
| K221127 | Sientra, inc. Portfinder | Sientra, Inc. | LCJ | Unclassified | |
| K220437 | Neurophet AQUA | Neurophet, Inc. | LLZ | Class II | |
| K230721 | ATEC Lateral Plate System | Alphatec Spine, Inc. | KWQ | Class II | |
| K223825 | Tens & Ems Device | Shenzhen Jian Feng Electronic Technology Co., Ltd | NUH | Class II | |
| K223655 | Catalyst R1 Reverse Shoulder System | CATALYST ORTHOSCIENCE Inc | PHX | Class II | |
| K223335 | SIRION Lateral Lumbar Interbody System | Astura Medical | MAX | Class II | |
| K223025 | Tyvek Roll with CI for STERLINK Sterilizer | Plasmapp Co., Ltd. | FRG | Class II | |
| K223023 | Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co., Ltd. | FRC | Class II | |
| K223015 | STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette | Plasmapp Co., Ltd. | MLR | Class II | |
| K222719 | Cx50n | Wide Corporation | PGY | Class II | |
| K222484 | Retitrack | C. Light Technologies, Inc. | HLL | Class II | |
| K222436 | Latitud™ Hip Replacement System | Meril Healthcare Pvt. Ltd. | LPH | Class II | |
| K212857 | Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use | Jiangsu Zhiyu Medical Instrument Co., Ltd | FMF | Class II | |
| DEN220083 | Stanza | Swing Therapeutics, Inc. | QWI | Class II | |
| K230674 | JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 | CC Wellness LLC | NUC | Class II | |
| K223428 | Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A) | Shenzhen Leqing Medical Instrument Co., Ltd. | NUH | Class II | |
| K223280 | Disposible Nitrile Gloves | Holik Asia Group Co.,Ltd | LZA | Class I | |
| K222716 | Mx50n | Wide Corporation | PGY | Class II | |
| K222487 | Anika Tissue Tack Fixation System | Anika Therapeutics, Inc. | GDW | Class II | |
| K231017 | Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. | OCC | Class II | |
| K230989 | Rod Registration Frame | Nu Vasive, Incorporated | OLO | Class II | |
| K230637 | Wattson temporary pacing guidewire (2250) | Vascular Solutions LLC | DQX | Class II | |
| K230616 | Polyguard and Polyshield Safety IV Catheters | Poly Medicure Limited | FOZ | Class II | |
| K230615 | Electric Scooter (Model: S3312) | Guangdong Prestige Technology Co., Ltd. | INI | Class II | |
| K230351 | LED Facial Mask | Shenzhen Sungpo Hi-Tech Electronic Co., Ltd | OHS | Class II | |
| K223858 | Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.r.l. | FLE | Class II |