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 |
|---|---|---|---|---|---|
| K240126 | ProAM ALIF System | Pro Surgical, Inc. | OVD | Class II | |
| K234088 | Emily's Care Nourish Test System (Model 1) | Lactation Lab, Inc. | QEI | Class II | |
| K234021 | Masimo Stork | Masimo Corporation | QYU | Class II | |
| K233687 | ECHELON Synergy V10.0 | FUJIFILM Healthcare Americas Corporation | LNH | Class II | |
| K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) | Hollister Incorporated | EZD | Class II | |
| K233349 | Alinity m HSV 1 & 2 / VZV | Abbott Molecular, Inc. | PGI | Class II | |
| K233157 | VaporMAX LDD; MOJo LDD; MegaJOULE LDD | Innovaquartz LLC | GEX | Class II | |
| K232941 | Megaloop Button System | Suzhou Endophix Co., Ltd. | MBI | Class II | |
| K232895 | B-Ultrasound Diagnostic System | Contec Medical Systems Co., Ltd. | IYO | Class II | |
| K232776 | Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer | Outset Medical, Inc. | KDI | Class II | |
| K232735 | Ema 3D | Ema Sleep Incorporated | LRK | Class II | |
| K232733 | Mbrace Cable | Medacta International SA | JDQ | Class II | |
| K232648 | RODEO Telescopic Nail | Orthofix SRL | HSB | Class II | |
| K232491 | CT 5300 | Philips Healthcare (Suzhou) Co., Ltd. | JAK | Class II | |
| K232454 | Viral Transport Media (VTM) | Alb Luz | JSM | Class I | |
| K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | Arkray, Inc. | LKM | Class II | |
| K240636 | HemoScreen Hematology Analyzer | Pixcell Medical Technologies, Ltd. | GKZ | Class II | |
| K240261 | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) | Merit Medical Systems, Inc. | KRD | Class II | |
| K240037 | Revi™ System | Bluewind Medical Ltd. | QXM | Class II | |
| K240012 | Mobility Scooter (W3431) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | INI | Class II | |
| K233857 | Neodent Implant System – Custom Abutments | JJGC Industria e Comercio de Materiais Dentarios SA | NHA | Class II | |
| K233752 | Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps | Centerpoint Systems LLC | FBN | Class II | |
| K233689 | Hope&Her Vaginal Dilators | Lujena, Inc. | HDX | Class II | |
| K232908 | Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) | Contec Medical Systems Co., Ltd. | IYN | Class II | |
| K232902 | EVA15 insufflator | Palliare | HIF | Class II | |
| K232464 | VereSee Optical Veres Needle System | Freyja Healthcare, LLC | HIF | Class II | |
| K232445 | Csf-4 (Csf-4) | Cardiacsense | DPS | Class II | |
| K240986 | Cold Compression | JKH Health Co., Ltd. | IRP | Class II | |
| K240925 | DuraGraft Vascular Conduit Solution | Marizyme, Inc. | QEJ | Class II | |
| K240900 | HOTWIRE™ RF Guidewire | Atraverse Medical | DXF | Class II | |
| K240882 | BruxZir® Esthetic | Prismatik Dentalcraft, Inc. | EIH | Class II | |
| K240829 | AuST Steerable Sheath | Centerpoint Systems LLC | DYB | Class II | |
| K240279 | Vidas Tbi (Gfap, Uch-L1) | bioMerieux, Inc. | QAT | Class II | |
| K234113 | MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box | Medimaging Integrated Solution, Inc (Miis) | EOQ | Class II | |
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | Reichert, Inc. | HKY | Class II | |
| K233513 | Remex Spine Surgery Navigation System II | Remex Medical Corp. | OLO | Class II | |
| K233284 | Vial Adapter with Filter | Hangzhou Qiantang Longyue Biotechnology Co.,Ltd | LHI | Class II | |
| K233203 | Soft Tissue Augmentation Resorbable Matrix | Collagen Matrix, Inc | NPL | Class II | |
| K232858 | ORskin Blue | Megabay S.A. | GEX | Class II | |
| K232370 | Percutaneous Nephroscope System | Karl Storz SE & Co. KG | FGA | Class II | |
| K231722 | SmarTooth | Smartooth Co., Ltd. | NBL | Class II | |
| K240621 | Morpheus® Moldable; Agilon® Moldable | Biogennix, LLC | MQV | Class II | |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024) | Physio Control, Inc. | DSA | Class II | |
| K240118 | Picosecond Nd:YAG Laser System | Smedtrum Medical Technology Co. Ltd. | GEX | Class II | |
| K233403 | Flexset System | Zeto, Inc. | GWQ | Class II | |
| K233231 | Dental Implants and Abutments | Ditron Dental Ltd | DZE | Class II | |
| K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) | Litu Tech Ltd. | EFB | Class I | |
| K232923 | Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0) | Varian Medical Systems, Inc. | IYE | Class II | |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | JEY | Class II | |
| K232528 | Protective Cap | Neobiotech Co., Ltd. | NHA | Class II |