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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K222658 | Accurate 24 Non-invasive blood pressure monitor | Accurate Meditech, Inc. | DXN | Class II | |
| K221311 | Antibacterial Bandage | Winner Medical Co., Ltd. | FRO | Unclassified | |
| K231459 | HepaFatSmart (V2.0.0) | Resonance Health Analysis Services Pty Ltd | LNH | Class II | |
| K231148 | ScleroSafe™ 150 mm, ScleroSafe™ 350 mm | Vvt Medical, Ltd. | KRA | Class II | |
| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) | Carl Zeiss Meditec Inc | IZI | Class II | |
| K230993 | CODA™ Anterior Cervical Plate System | Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech | KWQ | Class II | |
| K230796 | Sparrow Ascent | Spark Biomedical Inc. | PZR | Class II | |
| K230781 | Belle Sensilube | Rb Health (Us), LLC | NUC | Class II | |
| K230346 | Voluson SWIFT; Voluson SWIFT+ | GE Medical Systems Ultrasound and Primary Care Diagnostic | IYN | Class II | |
| K223535 | SMARTbase Abutment System | Implant Direct Sybron Manufacturing LLC | NHA | Class II | |
| K223522 | NC° Thermometer (Gen 3), Model Number: NCTG3 | Xiamen Intretech, Inc. | FLL | Class II | |
| K223103 | BethaLoc® stem cementless HA | implantcast GmbH | LZO | Class II | |
| K223029 | Perfit CL | Vatech mcis Co., Ltd. | EIH | Class II | |
| K222998 | F3 | Acrew Imaging, Inc. | OWB | Class II | |
| K221024 | tremoflo C2 Airwave Oscillometry System | Thorasys Thoracic Medical Systems Inc. | PNV | Class II | |
| K220072 | Sinobot X1 | Sinovation (Beijing) Medical Technology Co., Ltd | HAW | Class II | |
| K223920 | Vinno G50, Vinno G55, Vinno M50, Vinno E30, Vinno X5, Vinno X6, Vinno X7, Vinno M55, Vinno E35, Vinno X65, Vinno X55, Vinno X35, Vinno G55e, Vinno G55p, Vinno M55e, Vinno M55p, Vinno E35e, Vinno E35p | Vinno Technology (Suzhou) Co.,Ltd | IYN | Class II | |
| K223917 | Vinno E20, Vinno E10,vinno E10p,vinno E10e, Vinno X1,vinno X1e,vinno X1p, Vinno X2,vinno X2e,vinno X2p | Vinno Technology (Suzhou) Co.,Ltd | IYN | Class II | |
| K231461 | Smart Correction System (HA Half Pins) | Wishbone Medical, Inc. | KTT | Class II | |
| K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | MAX | Class II | |
| K231136 | Fitness Belt (Model: KLT-07) | Shenzhen Kelutongda Industrial Co., Ltd. | NGX | Class II | |
| K231110 | Manual Wheelchair (A006) | Ningbo Shenyu Medical Equipment Co., Ltd. | IOR | Class I | |
| K231045 | Healgen URS Test Strips | Healgen Scientific LLC | LJX | Class I | |
| K230965 | Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens | Acuity Polymers Inc. | HQD | Class II | |
| K230910 | NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens | Acculens, Inc. | HQD | Class II | |
| K230894 | NuVasive Modulus ALIF System | Nu Vasive, Incorporated | OVD | Class II | |
| K230538 | All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid | Sonova AG | QUH | Class II | |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series | Nikkiso Co., Ltd. | KOC | Class II | |
| K230421 | SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K230015 | OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver | Laurane Medical SAS | KNW | Class II | |
| K223890 | NAJA Gastrointestinal Catheter | Chess Medical Inc. | FGD | Class II | |
| K223646 | IB Lab LAMA | IB Lab GmbH | QIH | Class II | |
| K223556 | DeepCatch | MEDICAL IP Co., Ltd. | QIH | Class II | |
| K223357 | EyeArt v2.2.0 | Eyenuk | PIB | Class II | |
| K223217 | Zynex Monitoring System, Model CM-1600 | Altivera Medical, Inc. | DSB | Class II | |
| K222999 | Surgical Gown | Hubei Woozon Healthcare Co., Ltd. | FYA | Class II | |
| K222906 | Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 | Ningbo Maxcon Medical Technology Co., Ltd | MMK | Class II | |
| K222597 | BabySat 3 | Owlet Babycare, Inc. | DQA | Class II | |
| K221121 | Volumat Polyethylene I.V. Administration Set | Fresenius Kabi AB | FPA | Class II | |
| K220907 | The iNAP One Sleep Therapy System | Somnics, Inc. | OZR | Class II | |
| K220703 | F&P 950 Respiratory Humidifier | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K220107 | Mindray SV600 Ventilator, Mindray SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | CBK | Class II | |
| DEN220048 | Neoasis | Invictus Medical, Inc. | QWX | Class II | |
| K231109 | Xerxes Hip Stem | Xerxes Arthopedix, LLC | LZO | Class II | |
| K231090 | Zevo Anterior Cervical Plate System | Medtronic Sofamor Danek USA Inc | KWQ | Class II | |
| K231023 | ERBEJET® 2 System | ERBE Elektromedizin GmbH | FQH | Class II | |
| K230762 | EDEN Spinal Fixation MIS System | Jmt Co., Ltd. | NKB | Class II | |
| K230718 | UTC 3mL Medication Cartridge | Gilero, Inc | MRZ | Class II | |
| K230473 | IPL Hair Removal Device Models: MLY-T069 | Miley Technology (Hebei) Co., Ltd | OHT | Class II | |
| K230386 | SpassageQ | Spass, Inc. | PLB | Class II |