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 |
|---|---|---|---|---|---|
| K231724 | Flush Syringe (Prefilled 0.9% normal saline solution) | SPM Medicare Pvt, Ltd. | NGT | Class II | |
| K231617 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K231508 | Power Wheelchair, W5521 | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | ITI | Class II | |
| K231366 | Neuronaute Plus | Bioserenity SAS | GWQ | Class II | |
| K231277 | TissueStat | DuraStat | NBY | Class II | |
| K231150 | Cardio P1 | Bionet Co., Ltd. | DPS | Class II | |
| K230969 | Oxygen Concentrator | Jiangsu Jumao X-Care Medical Equipment Co., Ltd | CAW | Class II | |
| K230828 | Flowflex COVID-19 Antigen Home Test | Acon Laboratories, Inc. | QYT | Class II | |
| K223754 | BraveCX | Bering Limited | QFM | Class II | |
| K223682 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit | Sirius Medical Systems B.V. | PBY | Class II | |
| K222780 | LILY Extension Tube and Needleless Connector | Lily Medical Corporation | FPA | Class II | |
| K232886 | INFILOOP® Fixed Loop UHMWPE Suture Titanium Button | Healthium MedTech Limited | MBI | Class II | |
| K232152 | NerivioInfinity | Theranica Bio-Electronics Ltd. | QGT | Class II | |
| K231798 | da Vinci SP Surgical System | Intuitive Surgical, Inc. | NAY | Class II | |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U | Spectrum Medical Inc | DTZ | Class II | |
| K231765 | Contour ProtégéAI | MIM Software Inc | QKB | Class II | |
| K230534 | BriefCase-Quantification | Aidoc Medical Ltd. | QIH | Class II | |
| K230400 | Cure Catheter Closed System; Cure Dextra Closed System | ConvaTec Limited | EZD | Class II | |
| K223739 | VS Tabletop Tonometer | Medimaging Integrated Solution Inc. | HKX | Class II | |
| DEN220091 | Dream Sock | Owlet Babycare, Inc. | QYU | Class II | |
| K233420 | Axium Detachable Coil; Axium Prime Detachable Coil | Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular | HCG | Class II | |
| K232866 | Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) | Jiangsu Channel Medical Device Co., Ltd. | GCJ | Class II | |
| K232476 | Disposable Sphincterotome | Zhejiang Soudon Medical Technology Co.,Ltd | KNS | Class II | |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | MAX | Class II | |
| K231989 | LOGIQ E10s, LOGIQ Fortis | GE Medical Systems Ultrasound and Primary Care Diagnostic | IYN | Class II | |
| K231966 | Logiq E10 | GE Healthcare | IYN | Class II | |
| K231155 | Biodegradable Medical surgical mask | Guangdong Kingfa Sci.&tech.co.,Ltd. | FXX | Class II | |
| K232857 | KARL STORZ ICG Imaging System | Karl Storz SE & Co. KG | OWN | Class II | |
| K231865 | Mouth Guard (ATG0603R) | Reazeal Corp | OBR | Unclassified | |
| K231519 | Revital Cady | Revital Healthcare (Epz) Limited | FMF | Class II | |
| K231470 | Lunit INSIGHT DBT | Lunit Inc. | QDQ | Class II | |
| K231316 | Aptima Trichomonas vaginalis Assay | Hologic, Inc. | OUY | Class II | |
| DEN220090 | EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748) | Stemcell Technologies Canada, Inc. | QYO | Class II | |
| K233428 | Easycess Aspiration Pump | Guangzhou Easycess Medical Co.,Ltd | JCX | Class II | |
| K232742 | Arthrex FiberTak Suture Anchor | Arthrex GmbH | MBI | Class II | |
| K232382 | Control-IQ Technology | Tandem Diabetes Care, Inc. | QJI | Class II | |
| K232380 | t:slim X2 Insulin Pump with Interoperable Technology | Tandem Diabetes Care, Inc. | QFG | Class II | |
| K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Better Care Plastic Technology Co., Ltd. | LZA | Class I | |
| K232251 | APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension | Medartis AG | HWC | Class II | |
| K232186 | LOGIQ e | GE Medical Systems Ultrasound and Primary Care Diagnostic | IYN | Class II | |
| K232113 | Halcyon, Ethos Radiotherapy System | Varian Medical Systems, Inc. | IYE | Class II | |
| K231955 | aprevo® Digital Segmentation | Carlsmed, Inc. | QIH | Class II | |
| K231918 | Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter | Koru Medical Systems, Inc. | FRN | Class II | |
| K231586 | Endophys Blood Pressure Monitor model BPM-30 | Endophys Technologies, LLC | DSK | Class II | |
| K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC) | Manamed LLC | NUH | Class II | |
| K231440 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. Ltd. | IPF | Class II | |
| K231254 | GripTract-GI Endoscopic Tissue Manipulator | Actuated Medical, Inc. | FDF | Class II | |
| K231182 | Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System | ZOLL Circulation, Inc. | NZE | Class II | |
| K230481 | Evenflo Premium Double Electric Breast Pump (Model 4018) | Evenflo Feeding, Inc. | HGX | Class II | |
| K230475 | Medical Video Endoscope System | Huger Medical Instrument Co., Ltd. | FGB | Class II |