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 |
|---|---|---|---|---|---|
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System | Encore Medical, LP | PHX | Class II | |
| K250971 | Embosphere Microspheres | Biosphere Medical, S.A. | KRD | Class II | |
| K250141 | Synthecure Synthetic Calcium Sulfate | Austin Medical Ventures, Inc. | MQV | Class II | |
| K250110 | Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6); | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K250099 | Mobius3D (4.1) | Varian Medical Systems, Inc. | IYE | Class II | |
| K250086 | OTS Hip | Ortoma AB | OLO | Class II | |
| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) | Shenzhen Desida Technology Co., Ltd. | BTA | Class II | |
| K244008 | Spectral CT | Philips Medical Systems Technologies Ltd. | JAK | Class II | |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG | LZO | Class II | |
| K243837 | iBSM | Iorbit Digital Technologies Private Limited | DRG | Class II | |
| K243617 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | |
| K243602 | Arthrex Spine Endoscope | Arthrex GmbH | HRX | Class II | |
| K243371 | Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 | Byonyks Pvt Ltd | FKX | Class II | |
| K243176 | BLESSING System | Cellah Medical Co., Ltd. | GEI | Class II | |
| K243105 | Ruby Intravascular Catheter | Venocare, Inc. | FOZ | Class II | |
| K242731 | MasteRad MiniX Mobile Digital Imaging System (Mini-X) | Medicatech USA | OWB | Class II | |
| K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | Fujirebio Diagnostics, Inc. | SET | Class II | |
| K242585 | Cystatin C | Sentinel CH SpA | NDY | Class II | |
| K242569 | Mixed Reality Spine Navigation | Brainlab, Inc. | SBF | Class II | |
| K242438 | Clearo | Breas Medical AB | NHJ | Class II | |
| K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote S.p.A. | IYN | Class II | |
| K241581 | Hemodialysis Catheter | Haolang Medical USA Corporation | MSD | Class II | |
| K240554 | InferRead Lung CT.AI | Infervision Medical Technology Co., Ltd. | OEB | Class II | |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | C.R. Bard Inc | LDF | Class II | |
| K251156 | NPseal | Guard Medical, Inc. | OKO | Class II | |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | Hardy Diagnostics | JTN | Class II | |
| K250451 | NeurAxis IB-Stim (01-1020) | Neuraxis, Inc | QHH | Class II | |
| K250444 | NEXUS® Hip Stem | Microport Orthopedics Inc. | LZO | Class II | |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) | Olympus Medical Systems Corp. | FDF | Class II | |
| K250276 | Nitinol Enhanced Device (NED) | Embolization Inc | KRD | Class II | |
| K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) | Stryker Corp. | GXI | Class II | |
| K243165 | Limfa Therapy System (Limfa Therapy) | Eywa SRL | NGX | Class II | |
| K242931 | Hft750u | Mekics Co., Ltd. | MNT | Class II | |
| K242519 | Lumify Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K242518 | Hypertension Prediction Index (HePI) Algorithm | Edwards Lifesciences LLC | QAQ | Class II | |
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU | Nikkiso Co., Ltd. | KOC | Class II | |
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) | Nikkiso Co., Ltd. | KOC | Class II | |
| K242155 | DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) | Nikkiso Co., Ltd. | KDI | Class II | |
| K240857 | Youmagic FLM System (YM5-U1) | We Medical Technology (Wuxi) Co., Ltd. | GEI | Class II | |
| K251288 | Veincare | WONTECH Co., Ltd. | GEX | Class II | |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) | Ethicon Endo-Surgery Inc | GDW | Class II | |
| K250813 | MICROLET®NEXT 2 Lancing Device | Medrad, Inc. | QRL | Class II | |
| K250775 | Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System | Imperative Care Inc. | QEW | Class II | |
| K250712 | Linkt Compression Staple System | Trax Surgical, Inc. | JDR | Class II | |
| K250533 | Magnesium alloy scooter (RS100) | Taizhou Reach Technology Co., Ltd. | INI | Class II | |
| K250420 | Helios Dura Regeneration Matrix | Helios Biomedical Inc. | GXQ | Class II | |
| K250414 | CaloPix | Tribun Health | QKQ | Class II | |
| K250405 | Nerivio; Nerivio Infinity | Theranica Bio-Electronics Ltd. | QGT | Class II | |
| K250041 | Medical Picosecond ND: YAG Laser System (PZ-6) | Zhengzhou PZ Laser Slim Technology Co., Ltd | GEX | Class II | |
| K243830 | Disposable ureteral stent | Shenzhen Trious Medical Technology Co., Ltd | FAD | Class II |