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 |
|---|---|---|---|---|---|
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody System | Atlas Spine, Inc. | MAX | Class II | |
| K251877 | JMS CAVEO A.V. Fistula Needle Set | JMS North America Corp. | FIE | Class II | |
| K251871 | FEATHER 01 02 03 04 (Model:01) | Heat in a Click LLC | OHS | Class II | |
| K251834 | Persona Partial Knee | Zimmer GmbH | HSX | Class II | |
| K251747 | VEA Align; spineEOS | EOS imaging | QIH | Class II | |
| K251243 | OneRF Trigeminal Nerve Radiofrequency Probes | Neuroone Medical Technologies Corp. | GXI | Class II | |
| K250867 | Dunamis Screw and Suture Locking System | Dunamis Medical LLC | HWC | Class II | |
| K250818 | Nerveblox | Smart Alfa Teknoloji San. ve Tic. A.S. | QRG | Class II | |
| K250620 | KLS Martin Ixos System | KLS-Martin L.P. | HRS | Class II | |
| K250397 | Helios Dermal Scaffold | Helios Biomedical Inc. | KGN | Unclassified | |
| K250170 | Pharos | Brightonix Imaging Inc. | KPS | Class II | |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) | Siemens Healthcare Diagnostics Inc. | LTT | Class II | |
| K243851 | Chloe Blast | Fairtility Ltd. | PBH | Class II | |
| K243650 | Zio® monitor (DFG0001) | iRhythm Technologies, Inc. | DSH | Class II | |
| K251526 | FilmArray GI Control Panel M238 | Maine Molecular Quality Controls, Inc. | PMN | Class II | |
| K251176 | IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C) | Shenzhen Mlay Intelligent Technology Co., Ltd. | OHT | Class II | |
| K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack | Geistlich Pharma AG | NPL | Class II | |
| K251012 | TRUDERMAL Pro (ZLD-390) | Shenzhen Kaiyan Medical Equipment Co., Ltd | OHS | Class II | |
| K250916 | WinForth (LM-E470KA) | Shenzhen Leaflife Technology Co., Ltd. | PBX | Class II | |
| K250898 | Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) | Stryker Sustainability Solutions | NLQ | Unclassified | |
| K250164 | Cassette Autoclave (ACA5) | Guangzhou Ajax Medical Equipment Co Ltd | FLE | Class II | |
| K243905 | Stitch Cerclage – Suture Tapes | GM dos Reis Industria e Comercio Ltda | JDQ | Class II | |
| K243600 | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.ltd. | HKI | Class II | |
| K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | BioFire Diagnostics, LLC | QOF | Class II | |
| K243437 | mOm Essential Incubator (ME1) | Mom Incubators Limited | FMZ | Class II | |
| K252226 | Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) | Nuwellis, Inc. | NQJ | Class II | |
| K252201 | HS Fiber | Riverpoint Medical, LLC | GAT | Class II | |
| K252192 | Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) | Huizhou LVB Maternal and Infant Supplies Co., Ltd. | HGX | Class II | |
| K251569 | Bone Screw | OSSTEM Implant Co., Ltd. | DZL | Class II | |
| K251519 | RelieVRx (Pico G3) | Appliedvr | QRA | Class II | |
| K251495 | MBT Compass HT CA Software; MBT FAST Shuttle US IVD | Bruker Daltonics GmbH & Co. KG | QBN | Class II | |
| K251046 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | DZE | Class II | |
| K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. | HEB | Class II | |
| K250931 | Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121) | Unimed Medical Supplies Inc | DQA | Class II | |
| K250841 | Electrotherapy Electrodes | Baisheng Medical Co.,Ltd. | GXY | Class II | |
| K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker Corp. | HSB | Class II | |
| K243653 | KARL STORZ HOPKINS Telescopes for Urology | Karl Storz SE & Co. KG | FAJ | Class II | |
| K243579 | AeroJet Ventilation Catheter | Pipeline Medical Products, LLC | BTR | Class II | |
| K243279 | DOLORCLAST Focused Shock Waves | E.M.S. - Electro Medical Systems SA | PZL | Class II | |
| K252083 | HOTWIRE™ System RF Generator and Footswitch (optional accessory) | Atraverse Medical | GEI | Class II | |
| K251879 | Sulopenem SPM 2 µg | Liofilchem S.r.l. | JTN | Class II | |
| K251494 | Eko Foundation Analysis Software with Transformers (EFAST) | Eko Health, Inc. | DQD | Class II | |
| K250836 | 14F Duo-Flow® Side X Side Double Lumen Catheter | Medical Components, Inc. | MPB | Class II | |
| K250755 | DS Core Diagnosis | Dentsply Sirona Inc | QIH | Class II | |
| K250294 | Straumann® RidgeFit Implants | Straumann USA, LLC | DZE | Class II | |
| K243562 | CuffGuard | Idmed | BSK | Class II | |
| K252211 | Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) | Cnc Technologies | GEI | Class II | |
| K251873 | Saige-Dx | Deephealth | QDQ | Class II | |
| K251862 | External Fixation Bone Distractor | Paragon 28 | KTT | Class II | |
| K251823 | UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S) | Zhejiang UE Medical Corp. | EOQ | Class II |