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 |
|---|---|---|---|---|---|
| K230380 | Surgical Face Masks, Model: EFMDS-L50Pn BLU | Iris USA Inc | FXX | Class II | |
| K223551 | Sterile Water for Inhalation in 1L Flexoval ® bottles. | Hometa, Inc. | BTT | Class II | |
| K223542 | TubaVent Balloon Dilatation System | Spiggle & Theis Medizintechnik GmbH | PNZ | Class II | |
| K223133 | VisiRad XR | Imidex, Inc. | MYN | Class II | |
| K223122 | Menix®; Menix® Duo | S.B.M. SAS (Science & Bio Materials) | GAT | Class II | |
| K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | Globus Medical, Inc. | MAX | Class II | |
| DEN230003 | Viz HCM | Viz. Ai, Inc. | QXO | Class II | |
| K232030 | Ingenia Elition R5.7.1 SP4 MR Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K231942 | Mineral Collagen Composite Bioactive Extra Moldable | Collagen Matrix, Inc | MQV | Class II | |
| K231593 | Sapphire X3 Anterior Cervical Plate System | Spinal Elements, Inc | KWQ | Class II | |
| K231344 | ActivSight Intraoperative Imaging System | Activ Surgical Inc | OWN | Class II | |
| K231286 | Chemfort® Catheter Adaptor | Simplivia Healthcare Ltd. | ONB | Class II | |
| K231174 | Bpbio750 | InBody Co, Ltd. | DXN | Class II | |
| K231126 | Eblator Device | E Surgical, LLC | GEI | Class II | |
| K230748 | Disposable Ureteral Access Sheath | Youcare Technology Co.,Ltd. (Wuhan) | FED | Class II | |
| K230613 | Skeeper | Smartsound Corporation | DQD | Class II | |
| K223821 | Self-Cath Closed System | MEDLINE INDUSTRIES, LP - Northfield | FCM | Class II | |
| K223689 | Disposable Needle Guides and Grids | Advance Medical Designs Inc | ITX | Class II | |
| K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | Brainlab, Inc. | OLO | Class II | |
| K223114 | Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors | Gm dos Reis Industria E Comerico Ltda. | MBI | Class II | |
| K221114 | Immunoglobulin G (IgG) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | CFN | Class II | |
| K231963 | Real Intelligence™ Cori™ | Blue Belt Technologies, Inc. | OLO | Class II | |
| K231959 | Expd 4357; Expd 4357P | DRTECH Corporation | MQB | Class II | |
| K231954 | Aristotle 18 Guidewire; Aristotle 24 Guidewire | Scientia Vascular | MOF | Class II | |
| K231620 | Nuubo Smart | Smart Solutions Technologies SL | DQK | Class II | |
| K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing | GA Health Company Limited | OCX | Class II | |
| K231278 | Knotless Suture Anchor | Riverpoint Medical, LLC | MBI | Class II | |
| K230873 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments | Southern Implants, (Pty.) Ltd. | NHA | Class II | |
| K230162 | uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | |
| K232088 | Altris IMS | Altris, Inc. | NFJ | Class II | |
| K231698 | AllTest Fentanyl Rapid Test (Urine) | Hangzhou AllTest Biotech Co.,Ltd | DJG | Class II | |
| K231613 | Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. | Zhuzhou Goldenhot Medical Technology Co.,Ltd | OHT | Class II | |
| K231591 | V-Print c&b temp | Voco GmbH | POW | Class II | |
| K231321 | Nooance Led And Laser Helmet | Shenzhen Kaiyan Medical Equipment Co., Ltd | OAP | Class II | |
| K230956 | BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System | BD Integrated Diagnostic Solutions | QOF | Class II | |
| K230858 | Quatera 700 | Carl Zeiss Meditec Inc | HQC | Class II | |
| K230630 | ZENEX Implant System_Narrow | Izenimplant Co., Ltd. | DZE | Class II | |
| K230004 | Disposable Hemoclip | Yangzhou Fartley Medical Instrument Technology Co., Ltd | PKL | Class II | |
| K223567 | CNS-2101 Central Monitor | Nihon Kohden Corp. | MSX | Class II | |
| K223097 | RenaNav Ureteroscope System | Centerpoint Systems LLC | FGB | Class II | |
| K221767 | Surgical Sutures with or without Needle | Huaian Seamen Medical Technology Co., Ltd. | GAP | Class II | |
| K222862 | SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC | Lotuxs Medtech (Suzhou) Co., Ltd. | GEX | Class II | |
| K231951 | SI-Cure Sacroiliac Joint Fusion System | Alevio, LLC | OUR | Class II | |
| K231931 | Adena-Zina Spinal System | Shanghai Sanyou Medical Co. Ltd | NKB | Class II | |
| K231618 | 3 Layer Surgical Mask (134252531) | Original Mattress Factory, Inc. | FXX | Class II | |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-E | Nikkiso Co., Ltd. | KOC | Class II | |
| K231552 | Dia-Cem | Diadent Group International | EMA | Class II | |
| K231480 | Bright MTA Sealer Plus | GENOSS Co., Ltd. | KIF | Class II | |
| K231313 | Therapy Mask 3100 NC/SP | Respironics, Inc. | BZD | Class II | |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL | PENTAX of America, Inc. | PEA | Class II |