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 |
|---|---|---|---|---|---|
| K250762 | Ultrasonic Probe Um-S20-17S (Um-S20-17S); Ultrasonic Probe Um-S20-20R (Um-S20-20R) | Olympus Medical Systems Corp. | ITX | Class II | |
| K250761 | KALA Therapy Wand (Model: KALA-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OHS | Class II | |
| K250671 | FreeStyle Comfort (AS200 / FreeStyle Comfort) | Caire, Inc. | CAW | Class II | |
| K250266 | Ceragem Automatic Thermal Massager (CGM MB-2401) | Ceragem Co., Ltd. | JFB | Class II | |
| K250156 | Choice 2 DC | Bisco Inc | EMA | Class II | |
| K250034 | Natural rubber latex male condom | Shaoguan Regenex Pharmaceuticals Co., Ltd. | HIS | Class II | |
| K243655 | TurbAlign | Spirair, Inc | LYA | Class I | |
| K243296 | Disposable Biopsy Needle | Carbon (Shenzhen) Medical Device Co., Ltd. | KNW | Class II | |
| K243274 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | Centers for Disease Control and Prevention | OZE | Class II | |
| K243227 | B-Scan | Accutome, Inc. Doing Business AS Keeler USA | IYO | Class II | |
| K241179 | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) | VivaQuant, Inc | QYX | Class II | |
| K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | Trimed Inc | HRS | Class II | |
| K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | Providence Medical Technology, Inc. | MRW | Unclassified | |
| K251830 | Sonosite LX Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K251169 | Vivid Pioneer | GE Healthcare | IYN | Class II | |
| K251145 | Arthrex PushLock Suture Anchors | Arthrex GmbH | MBI | Class II | |
| K250283 | RAP Femoral Venous Cannulae | LivaNova USA, Inc. | DWF | Class II | |
| K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer System | AVALIGN TECHNOLOGIES, Inc. | OVD | Class II | |
| K250063 | ARENA Star, Galaxy Star | ARUM DENTISTRY Co., Ltd. | EIH | Class II | |
| K250032 | Marquee™ Disposable Core Biopsy Instrument and Instrument Kit | Bard Peripheral Vascular Inc | KNW | Class II | |
| K244004 | Microcurrent Facial Device (CEC101, EE0101, EEI101) | Shenzhen Dachi Communication Co.,Ltd. | NFO | Class II | |
| K243252 | ZBPro Diagnostic | Zbeats, Inc | DPS | Class II | |
| K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers | Boston Scientific Corporation | GEX | Class II | |
| K251520 | Cios Alpha; Cios Flow | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K250505 | Ez-Fiducials | Phasor Health, LLC | HAW | Class II | |
| K250247 | panaSIa SI Fusion System | Wenzel Spine | OUR | Class II | |
| K250193 | Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) | Basic Medical Technology Inc. | LZA | Class I | |
| K250133 | HARBOR Occlusion Device | Nuvascular Inc. | KRD | Class II | |
| K250108 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | SBF | Class II | |
| K243731 | HEXIM Implant; Samwon General Abutments | P&a USA | DZE | Class II | |
| K243500 | ARCHITECT iGentamicin | Abbott Medical | LCD | Class II | |
| K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | NKB | Class II | |
| K251776 | EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) | Encore Medical, LP | JWH | Class II | |
| K251766 | TumorSight Viz | Simbiosys, Inc. | QIH | Class II | |
| K251761 | Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | Momentis Surgical Ltd. | QNM | Class II | |
| K251741 | PathLoc Lumbar Interbody Fusion Cage System | L&K Biomed Co.,Ltd. | MAX | Class II | |
| K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) | Terumo Europe N.V. | FMI | Class II | |
| K250695 | Single-use Ureteral Access Sheath | Shenzhen Hugemed Medical Technical Development Co., Ltd | FED | Class II | |
| K250342 | Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl | Encompass Industries Sdn. Bhd. | LZA | Class I | |
| K250065 | DENSITY; DENZA; DENSITY Noir | Jeisys Medical Incorporated | GEI | Class II | |
| K241525 | ExcelsiusXR™ | Globus Medical, Inc. | SBF | Class II | |
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | Spectrum Medical Inc | DTR | Class II | |
| K251863 | CustomSurg OrthoPlanner | Customsurg AG | LLZ | Class II | |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | Life Spine | MAX | Class II | |
| K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams | Carlsmed, Inc. | MAX | Class II | |
| K250496 | Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) | Zibo Shengkun Chemical Industry Co Ltd | LZA | Class I | |
| K243884 | Tavipilot | Caranx Medical | OWB | Class II | |
| K251671 | Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | Siemens Medical Solutions USA, Inc. | KPS | Class II | |
| K251599 | Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | FED | Class II |