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 |
|---|---|---|---|---|---|
| K243547 | uMR Ultra | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K243428 | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector | Dxtx Medical Inc. | MOS | Class II | |
| K243420 | Hestia | Genoray Co., Ltd. | MUE | Class II | |
| K243324 | Masimo O3 Regional Oximeter | Masimo Corporation | MUD | Class II | |
| K242505 | Elecsys Cortisol III | Roche Diagnostics GmbH | JFT | Class II | |
| K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | Kerecis Limited | KGN | Unclassified | |
| K251342 | EchoPAC Software Only / EchoPAC Plug-in | GE Healthcare | QIH | Class II | |
| K251202 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | NAY | Class II | |
| K251198 | HyperVue™ Software | Spectrawave, Inc. | NQQ | Class II | |
| K251151 | Rapid CTA 360 | Ischemaview, Inc. | QAS | Class II | |
| K251102 | Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) | Cemho Medical Technology (Guangdong) Co., Ltd. | DXN | Class II | |
| K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | Olympus Medical Systems Corp. | ODC | Class II | |
| K243782 | StimTrial Neuromodulation System | Bioventus LLC | GZF | Class II | |
| K243412 | ARCHIMEDES Biodegradable Pancreatic Stent | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | FGE | Class II | |
| K243397 | uMR 680 | Shanghai United Imaging Healthcare Co., Ltd. | LNH | Class II | |
| K251844 | Kerecis SurgiBind (50241) | Kerecis Limited | OXH | Class II | |
| K251053 | Shinetell PlusTM Digital Early Pregnancy Test | Hangzhou AllTest Biotech Co.,Ltd | LCX | Class II | |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) | Unimed Medical Supplies Inc | DXQ | Class II | |
| K250350 | Thrive 2-in-1 Breast Pump (Model P3) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K250181 | AV Viewer | Philips Medical Systems Nederland B.V. | LLZ | Class II | |
| K250119 | Tempus ECG-Low EF | TEMPUS AI, Inc. | QYE | Class II | |
| K242818 | IsoSphere | Isoaid, L.L.C. | KXK | Class II | |
| K242237 | Jewel Soft Tissue Reinforcement Device (102-6005) | Xiros Limited | QUW | Class II | |
| K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28 | HSB | Class II | |
| K251554 | Materialise TKA Guide System | Materialise N.V. | JWH | Class II | |
| K251488 | FLOWRUNNER Aspiration System | Expanse Medical Inc. | QEZ | Class II | |
| K251378 | CoolTone | Zimmer Medizinsysteme GmbH | NGX | Class II | |
| K251173 | Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF) | Shenzhen Fansizhe Science and Technology Co., Ltd. | OHT | Class II | |
| K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws | Acumed LLC | HRS | Class II | |
| K251096 | PeekMed web | Peek Health, S.A. | QIH | Class II | |
| K250660 | LUMINOS Q.namix T; LUMINOS Q.namix R | Siemens Medical Solutions | OWB | Class II | |
| K250504 | Leonardo Duster | Ceramoptec GmbH | GEX | Class II | |
| K250185 | Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) | Jiangxi Aicare Medical Technology Co., Ltd | DXN | Class II | |
| K250120 | Gecho | Narnar, LLC | LLZ | Class II | |
| K243917 | F&P Optiflow Air/Oxygen Flow Source | Fisher & Paykel Healthcare, Inc. | BZR | Class II | |
| K243598 | Welch Allyn Connex® 360 (Multiple) | Welch Allyn Inc | |||
| K243199 | NightWatch+ US | Livassured | POS | Class II | |
| K251808 | Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K251786 | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | Geistlich Pharma AG | NPM | Class II | |
| K251482 | AEON™ Endoscopic Powered Stapler | Lexington Medical, Inc. | GAG | Class II | |
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System | Inion Oy | HBW | Class II | |
| K251470 | ResiCem EX | Shofu Dental Corp. | EMA | Class II | |
| K251436 | Resolve Anterior Cervical Plate System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | KWQ | Class II | |
| K251352 | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) | Codonics.Incorporated | BSZ | Class II | |
| K251155 | BD Cathena™ Safety IV Catheter | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | Class II | |
| K251149 | AviClear Laser System | Cutera Inc | GEX | Class II | |
| K251134 | RipCord | Trimed Inc | HTN | Class II | |
| K250942 | Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHT | Class II | |
| K250820 | Disposable Trocars | Sinolinks Medical Innovation, Inc. | GCJ | Class II | |
| K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter | Medline ReNewal | NLH | Class II |