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 |
|---|---|---|---|---|---|
| K261451 | ZSAlign Cervical Interbody System | Zsfab Inc | OVE | Class II | |
| K261335 | VitalFlow Set with Balance™ Biosurface | Medtronic, Inc. | QJZ | Class II | |
| K261331 | I-Genius (100019400) | Esaote S.p.A. | LNH | Class II | |
| K261187 | Hearing Aid Feature | Samsung Electronics Co., Ltd. | SCR | Class II | |
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corp. | ODG | Class II | |
| K260936 | RadioViewAI | NEUROCAREAI Inc (dba SaveLife.AI) | LLZ | Class II | |
| K260852 | MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure | Siemens Healthineers AG | LNH | Class II | |
| K260607 | Shield System (Siemens 30x40) | Radiaction Ltd. | OWB | Class II | |
| K254042 | WatchPAT SW | Itamar Medical | MNR | Class II | |
| K253835 | Affinity | Hermes Medical Solutions AB | QIH | Class II | |
| K253800 | 0909Fce, 0909Fce-Hs | Rayence Co., Ltd. | MQB | Class II | |
| K253655 | Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Burmoos GmbH | DZI | Class II | |
| K253555 | Flexitouch® Plus Advanced Pneumatic Compression System | Tactile Medical | JOW | Class II | |
| K252812 | UniPearls® Embolic Microspheres | Suzhou Haowei Medical Technology Co., Ltd. | KRD | Class II | |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down | Stryker Corp. | MBI | Class II | |
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T | Philips Medical Systems Nederland B.V. | MOS | Class II | |
| K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | EIH | Class II | |
| K261835 | LOGIQ Focus | GE Healthcare | IYN | Class II | |
| K261448 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC | LFL | Unclassified | |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) | Suite 201, National Innovation Centre | OLO | Class II | |
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | Salter Labs | CCL | Class II | |
| K261288 | Handheld Ultrasound Scanner | Imgfax Co., Ltd. | IYN | Class II | |
| K260980 | cmAngio® V2.0 | Curemetrix, Inc. | QIH | Class II | |
| K260624 | Arthrex Radial Head Replacement System | Arthrex GmbH | KWI | Class II | |
| K260620 | SeptAlign (SPLN001) | Spirair, Inc | NHB | Class II | |
| K260566 | SMARTVERTIGO™ Vestibular Assessment System | VertigoDx, Inc. | GWN | Class II | |
| K260161 | SmartGuide Disposable Guides and Grids | UC-Care | ITX | Class II | |
| K254038 | Motivista (CT-155) | Click Therapeutics, Inc. | SAP | Class II | |
| K252042 | Sync AV II Temporary Pacing Catheter | Swift Sync, Inc. | LDF | Class II | |
| K251959 | TnR Cranial Implant | T&R Biofab Co.,Ltd. | GXP | Class II | |
| K262240 | SSPC NXT Delivery Catheter | Centerpoint Systems LLC | DQY | Class II | |
| K262200 | Stone Clear (BWSC-LP9-02) | Sonomotion, Inc. | QNA | Class II | |
| K261829 | Profoject™ Dual-Safety Pen Needles | CMT Health Pte. Ltd. | FMI | Class II | |
| K261770 | Suture Button Repair System | Skeletal Dynamics, Inc | MBI | Class II | |
| K261766 | CPS Locator 3D Plus Delivery Catheter | Centerpoint Systems LLC | DQY | Class II | |
| K261210 | Cleerly Plaque | Cleerly, Inc | QIH | Class II | |
| K261205 | SPINEART Navigation Instrument System | Spineart SA | OLO | Class II | |
| K261058 | CraniUS Plate | CraniUS, LLC | GWO | Class II | |
| K260588 | Cleerly LABS | Cleerly, Inc | LLZ | Class II | |
| K253526 | NAMIC Dilator and Sheath | MEDLINE INDUSTRIES, LP - Northfield | DYB | Class II | |
| K251908 | Emanate Tray | Emanate Biomedical | OLR | Unclassified | |
| K261511 | Xpert Ankle | Newclip Technics | HRS | Class II | |
| K261430 | TruLift Expandable System | Life Spine | MAX | Class II | |
| K261427 | uMI Panvivo (uMI Panvivo M) | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System; | Samsung Medison Co., Ltd. | IYN | Class II | |
| K261399 | Elisio™-Hx | Nipro Medical Corporation | QAX | Class II | |
| K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Hartalega NGC Sdn Bhd | KGO | Class I | |
| K260326 | Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) | GE Healthcare | FMZ | Class II | |
| K260303 | See-Mode Augmented Reporting Tool, Breast (SMART-B) | See-Mode Technologies Pty Ltd | QDQ | Class II | |
| K253651 | Revi System | Bluewind Medical Ltd. | QXM | Class II |