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 |
|---|---|---|---|---|---|
| K231073 | SkinStylus SteriLock® MicroSystem, Model Number MP1209SL | Esthetic Medical, Inc. | QAI | Class II | |
| K230898 | FLUOBEAM® LX Red | Fluoptics SAS | QDG | Class II | |
| K230813 | BlueStar and BlueStar Rx | Welldoc | NDC | Class II | |
| K230801 | Pathfinder Endoscope Overtube with Balloon Device | Neptune Medical, Inc | FED | Class II | |
| K223781 | Quantisal™ II Oral Fluid Collection Device | Immunalysis Corporation | PJD | Class II | |
| K223710 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Medical | CGA | Class II | |
| K223670 | MESI mTablet ECG Diagnostic System, MESI mTablet ECG | Mesi, Development of Medical Devices, Ltd.; Mesi d.o.o. | DPS | Class II | |
| K222902 | Electrocardiograph: SE-1200 Pro and SE-1201 Pro | Edan Instruments, Inc. | DPS | Class II | |
| K222794 | FlowStar Touch Digital Mixer Flowmeter | Baldus Sedation GmbH & Co. KG | BZR | Class II | |
| K222735 | HJY VisualNext Endoscopic Vision System | Hjy Smart Medical Device Co., Ltd. | GWG | Class II | |
| K222587 | PatCom Distal Chip Endoscope | H&A Mui Enterprises, Inc. | EOB | Class II | |
| K231912 | Therm-X | Zenith Technical Innovations, LLC | IRP | Class II | |
| K231886 | SURGIVISIO Device | Ecential Robotics | OLO | Class II | |
| K231555 | LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) | iSMART Developments, Ltd. | OHS | Class II | |
| K231261 | Altaviz Needle Kit II | Altaviz, LLC | FMI | Class II | |
| K231236 | IBS-B MIS Beveled Screw System | In2bones USA, LLC | HWC | Class II | |
| K231223 | MDx-Chex for BC-GN | Streck LLC | PMN | Class II | |
| K231221 | MDx-Chex for BC-GP | Streck LLC | PMN | Class II | |
| K231195 | Brainomix 360 Triage ICH | Brainomix Limited | QAS | Class II | |
| K231044 | R2P Navicross | Terumo Medical Corp. | DQY | Class II | |
| K230838 | Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets | Cardinal Health200, LLC | FYA | Class II | |
| K230074 | Rapid Aneurysm Triage and Notification | Ischemaview, Inc. | QFM | Class II | |
| K223591 | cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System | Roche Molecular Systems Inc | QOF | Class II | |
| K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | EZL | Class II | |
| K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | DePuy Synthes | KTT | Class II | |
| K231787 | ecoFIX® | Science & Bio Materials, S.B.M. SAS | MAI | Class II | |
| K231572 | uMI Panorama | Shanghai United Imaging Healthcare Co., Ltd. | KPS | Class II | |
| K231172 | ApolloKnee | Corin USA | OLO | Class II | |
| K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences LLC | QNL | Class II | |
| K222994 | Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | |
| K222874 | CarboClear Cervical Cage System, CarboClear Cervical VBR System | Carbofix Orthpedics, Ltd. | ODP | Class II | |
| K220765 | HS Fiber Cerclage | Riverpoint Medical, LLC | JDQ | Class II | |
| K231924 | EZ-IO Intraosseous Vascular Access System | Teleflex Medical | FMI | Class II | |
| K231900 | A-TAP (previously called Arthrotap) | Elcam Medical A.C.A.L. | FMF | Class II | |
| K231878 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 | STERIS Corporation | FGB | Class II | |
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | Stryker Sustainability Solutions | OWQ | Class II | |
| K231577 | MOBILETT Impact | Siemens Medical Solutions | IZL | Class II | |
| K231275 | Exceed™ Biplanar Expandable Interbody System | Spine Wave Inc | MAX | Class II | |
| K230913 | Andi | Imeka Solutions Inc. | QIH | Class II | |
| K230730 | Apyx | Escala Medical | PBQ | Class II | |
| K230576 | Identify | Varian Medical Systems, Inc. | IYE | Class II | |
| K230540 | Patient Specific Planning Solution™ 3D Bone Models | Biomet Manufacturing Corp | LLZ | Class II | |
| K230455 | Enamel Coating Resin | Rizhao Huge Biomaterials Company, Ltd. | EBC | Class II | |
| K230365 | Sonio Detect | Sonio | IYN | Class II | |
| K223473 | Me-Apds™; Magentiq-Colo™ | Magentiq Eye Ltd | QNP | Class II | |
| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl) | Siemens Healthcare Diagnostics Inc. | JGS | Class II | |
| K221605 | Emit® II Plus Buprenorphine Assay | Siemens Healthcare Diagnostics Inc. | DJG | Class II | |
| K213536 | DEKA ACE Pump System | Deka Research & Development Corp. | QFG | Class II | |
| K231523 | EsCom250 | Spident Co., Ltd. | EBF | Class II | |
| K230333 | Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) | Kettenbach GmbH & Co KG | LBH | Class II |