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 |
|---|---|---|---|---|---|
| K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | OLI | Class II | |
| K232898 | Quantisal™ Oral Fluid Collection Device | Immunalysis Corporation | PJD | Class II | |
| K232719 | ProMIS Extension Rod System | Premia Spine Ltd. | NKB | Class II | |
| K232576 | Medical Nitrile Examination Gloves | Jiangsu Complete Sincerity Medical New Materials Co.,Ltd. | LZA | Class I | |
| K232573 | INFINITI™ Ambi Angiographic Catheter | Cordis US Corp. | DQO | Class II | |
| K232549 | NemoCast | Software Nemotec, S.L. | PNN | Class II | |
| K232546 | Meta G UCLA Abutment | Cowellmedi Co., Ltd. | NHA | Class II | |
| K232496 | Brainomix 360 Triage Stroke | Brainomix Limited | QAS | Class II | |
| K232388 | High Pressure Tubing | Ningbo Dizegens Medical Science Co.,Ltd | DXT | Class II | |
| K232001 | Nu Skin RenuSpa iO | Nse Products, Inc. | NFO | Class II | |
| K231975 | PNK Total Knee System | Tjc Life Co., Ltd. | JWH | Class II | |
| K231443 | Mini-OSTEO Pedicle Fixation System | Osteomed Indústria E Comércio de Implantes Ltda | NKB | Class II | |
| K230834 | CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H | Trismed Co., Ltd. | DPS | Class II | |
| K230773 | Endoscopy Irrigation Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. | OCX | Class II | |
| K230641 | Ultrasonic Scaler Tips | Guilin Refine Medical Instrument Co., Ltd. | ELC | Class II | |
| K230287 | SaviSafe Safety Device | Suzhou Savicred Biotechnology Co., Ltd. | MEG | Class II | |
| K230211 | CranioXpand | KLS-Martin L.P. | PBJ | Class II | |
| K223615 | Digital ClarusScope System, Digital NeuroPEN System | Clarus Medical, LLC | GWG | Class II | |
| K222511 | Oxy2Pro | Southmedic Inc. | CCK | Class II | |
| K221606 | Absorbable Cranial Flap Fixation System | Chendu Medart Medical Scientific Co., Ltd. | GXR | Class II | |
| K233351 | Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 0.5mm Tip with Cable (HNSAG-5115J); Single Use Non-Stick Jeweller Bipolar Forceps, 115mm, 1.0mm Tip with Cable (HNSAG-1115J); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 1.0mm Tip with Cable (HNSAG-1120A); Single Use Non-Stick Adson Bipolar Forceps, 120mm, 0.5mm Tip with Cable (HNSAG-5120A); Single Use Non-Stick Adson Bipolar Force | Hg Innovations, Ltd. | GEI | Class II | |
| K233346 | Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.0mm Tip with Cable (HMAL18/010); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 1.5mm Tip with Cable (HMAL18/015); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 0.5mm Tip with Cable (HMAL20/005); Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 200mm, 1.0mm Tip with Cable (HMAL20/010); | Hg Innovations, Ltd. | GEI | Class II | |
| K232575 | Hair Removal Device, Model(s): R2815-G Pro, R2815-G | Shenzhen Jianchao Intelligent Technology Co., Ltd. | OHT | Class II | |
| K232555 | Harmony | Topcon Healthcare Solutions | NFJ | Class II | |
| K232545 | The SensiTox B. anthracis Toxin Test | First Light Diagnostics, Inc. | QUU | Class II | |
| K231941 | ARIETTA x10 | FUJIFILM Healthcare Americas Corporation | IYN | Class II | |
| K231692 | Ziehm Vision RFD | Ziehm Imaging GmbH | OWB | Class II | |
| K231498 | TraumaCad Neo | Brainlab, Inc. | LLZ | Class II | |
| K230700 | RIWOtrack Navigation System | Fiagon GmbH | OLO | Class II | |
| K230627 | Zilia Ocular FC (ZIL-10002) | Zilia, Inc. | HKI | Class II | |
| K232974 | EKGenius Smart System | Ekgenius, LLC | DPS | Class II | |
| K232925 | Gastric Alimetry System | Alimetry Ltd | MYE | Class II | |
| K232538 | Dual Color Nitrile Examination Gloves, Powder Free, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl | WRP Asia Pacific Sdn Bhd | LZA | Class I | |
| K232512 | Masimo W1 | Masimo Corporation | DPS | Class II | |
| K232501 | AI Platform (AIP001) | Exo, Inc. | QIH | Class II | |
| K232028 | Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) | Iq Endoscopes Limited | FDS | Class II | |
| K231600 | SENDERO Microcatheter | Okami Medical Inc. | DQY | Class II | |
| K231559 | Multi-Unit DAS System | Talladium Espana, SL | NHA | Class II | |
| K231020 | Alinity c Tricyclic Antidepressants Reagent Kit | Microgenics Corporation | LFH | Class II | |
| K230954 | Samfilcon B Custom Contact Lens | Bausch + Lomb, Incorporated | LPL | Class II | |
| K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences LLC | MUD | Class II | |
| K230589 | Celox Rapid X-Ray Gauze | Medtrade Products Ltd. | QSY | Unclassified | |
| K230190 | Polyver Silver Alginate Dressing (Prescription and OTC) | Roosin Medical Co., Ltd. | FRO | Unclassified | |
| K233443 | Vital™ Navigation System | Zimvie Spine (Zimmer Biomet Spine, Inc.) | OLO | Class II | |
| K233302 | OSSIOfiber® Compression Staple | OSSIO, Ltd. | MNU | Class II | |
| K233200 | XPLUS 35 Series (XPLUS 35, XPLUS 35FD) | Gemss Healthcare Co., Ltd. | OWB | Class II | |
| K232945 | Trio-CT® Triple Lumen Catheter w/ Curved Extensions | Medical Components, Inc. | NIE | Class II | |
| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric | Alcon Laboratories | LPL | Class II | |
| K232753 | Expd 4343D; Expd 3643D | DRTECH Corporation | MQB | Class II | |
| K232533 | ROSA Partial Knee System | Orthosoft D/B/A Zimmer Cas | OLO | Class II |