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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K260714 | MammoScreen® (5) | Therapixel | QDQ | Class II | |
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | Shenzhen Dongdixin Technology Co., Ltd. | NUH | Class II | |
| K260061 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems Inc | NHA | Class II | |
| K260018 | Arthrex FiberButton | Arthrex GmbH | MBI | Class II | |
| K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) | Edwards Lifesciences LLC | PZX | Class II | |
| K253921 | VERTICALE® Navigation Instruments | Silony Medical GmbH | OLO | Class II | |
| K253316 | PhAST instrument and PhAST Blood Culture Gram-negative Panel | Phast Corp. | SAN | Class II | |
| K253306 | BioTracker 2.0 | Biotracker, LLC | |||
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) | Shenzhen Changkun Technology Co., Ltd. | HGX | Class II | |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | Depuy Ireland UC | JWH | Class II | |
| K261242 | SimplGuide | Pendracare | DYB | Class II | |
| K261025 | Wearable breast pump (QY-101, QY-102, QY-108) | Shenzhen Qinyi Electronic Technology Co., Ltd. | HGX | Class II | |
| K260992 | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) | Neuralytix LLC | PDQ | Class II | |
| K260809 | Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System | Arthrex GmbH | HWC | Class II | |
| K260790 | G-Series Grind Guard | ASESSO HEALTH, Inc. | OBR | Unclassified | |
| K260709 | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) | Longeviti Neuro Solutions | GXN | Class II | |
| K260480 | VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | OLO | Class II | |
| K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp. | LLZ | Class II | |
| K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | GN Hearing A/S | QUH | Class II | |
| K253786 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | QIH | Class II | |
| K253394 | Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture | Ethicon, Inc | GAM | Class II | |
| K253386 | DVT Garment | Vistar Medical Supplies Co., Ltd. | JOW | Class II | |
| K253384 | mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) | Seers Technology Co., Ltd. | MWJ | Class II | |
| K253367 | EliA CTD 13 Screen | Phadia AB | LLL | Class II | |
| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | BSZ | Class II | |
| K253274 | BedDot (G1) | Intelligent Dots, LLC | BZQ | Class II | |
| K253216 | IntraOp Alignment System; CONTOUR3D Bending System | Alphatec Spine, Inc. | SIN | Class II | |
| K252584 | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) | Weyo Surgical Technology, Ltd. | HIF | Class II | |
| K251188 | UNIQA® Dental Implants System | Uniqa Dental Ltd | DZE | Class II | |
| K261866 | Concerto Versa™ Detachable Coil | Medtronic, Inc. | KRD | Class II | |
| K261772 | Target Xtra Detachable Coil | Stryker Neurovscular | HCG | Class II | |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LB | Olympus Medical Systems Corp. | FET | Class II | |
| K261055 | AMSCO 700 Steam Sterilizer | STERIS Corporation | FLE | Class II | |
| K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | FRO | Unclassified | |
| K260998 | Ceribell Neurology Review Software | Ceribell, Inc. | OMB | Class II | |
| K260937 | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) | Shanghai Waylong Intelligent Technology Co., Ltd | ITI | Class II | |
| K260669 | Endoform Dermal Template | AROA Biosurgery Inc. | KGN | Unclassified | |
| K260394 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) | Hangzhou Jimushi Meditech Co., Ltd. | EZD | Class II | |
| K253560 | Enhanced Boundary for PCCT | GE Healthcare | JAK | Class II | |
| K253404 | CLEAR™ Aspiration System | Insera Therapeutics, Inc. | |||
| K253393 | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 | Hangzhou AGS MedTech Co., Ltd. | FGE | Class II | |
| K253263 | ConvaVAC™ Negative Pressure Wound Therapy System | ConvaTec Limited, GDC Building | OMP | Class II | |
| K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | SW Technologies Inc. | LZA | Class I | |
| K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals Inc | FRO | Unclassified | |
| K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) | Integra LifeSciences Production Corporation | JXG | Class II | |
| K253211 | AQUABEAM Robotic System | PROCEPT BioRobotics Corporation | PZP | Class II | |
| K253199 | Curasys 2 (Emdn0003) | CG Bio Co., Ltd. | OMP | Class II | |
| K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Microlife Corp. | BZH | Class II | |
| K261950 | Health Line Tearaway Introducer | Health Line International Corporation | DYB | Class II | |
| K261342 | Urocross Expander System (UES-2018-C1) | Prodeon Medical, Inc. | QKA | Class II |