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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K173410 | n!ce for Planmill | Straumann USA, LLC | EIH | Class II | |
| K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens | IYO | Class II | |
| K172759 | Smart External Drain (SED) System | Aqueduct Critical Care, Inc. | JXG | Class II | |
| K172531 | Biograph mMR with mMR Angio Transfer Option | Siemens Medical Solutions USA, Inc. | OUO | Class II | |
| K172157 | DePuy Synthes Femoral Recon Nail System | Synthes (USA) Products LLC | HSB | Class II | |
| K171769 | Straumann PURE Ceramic Implants | Straumann USA, LLC (on Behalf of Institut Straumann AG) | DZE | Class II | |
| K171385 | Planmeca Romexis | Planmeca Oy | LLZ | Class II | |
| K170859 | Dolphin/IQ and Dolphin/4D | Viasonix Ltd. | IYN | Class II | |
| K170799 | AP 50/30 Insufflator with Insuflow Port | Lexion Medical, LLC. | HIF | Class II | |
| K173166 | ANTHEM Fracture System | Globus Medical, Inc. | HRS | Class II | |
| K172703 | Disposable Snap Electrode | Embla Systems | GXY | Class II | |
| K172525 | Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs | Central Medicare Sdn Bhd | LZC | Class I | |
| K172344 | Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) | Medax S.r.l. Unipersonale | KNW | Class II | |
| K170931 | CXI TriForce Peripheral Crossing Set | Cook Incorporated | KRA | Class II | |
| K170725 | Stryker Universal Mesh | Stryker Corp. | GWO | Class II | |
| K170524 | Access AMH | Siemens Healthcare Diagnostics Inc. | PQO | Class II | |
| K170102 | Pekkton Ivory | Cendres+metaux SA | EBF | Class II | |
| K163595 | IMPIX 3D Print Cages | Medicrea International | MAX | Class II | |
| K171868 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | PZH | Class II | |
| K173271 | Aesculap Slim Clip Applier Forceps | Aesculap Inc | HCI | Class II | |
| K171902 | Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Inc. | OBP | Class II | |
| K173273 | Aquarius 8600 1417WCI; Aquarius 8600 1717WCI | Imaging Dynamics Company, Ltd. | MQB | Class II | |
| K172700 | OEC One | GE Hualun Medical Systems Co., Ltd. | OWB | Class II | |
| K172458 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit | Abbott Medical | DRS | Class II | |
| K172453 | WATCHDOG Hemostasis Valve Kit | Boston Scientific Corporation | DQX | Class II | |
| K172226 | MX40 Release B.07 | Philips North America LLC | MHX | Class II | |
| K172124 | Televere Podiatry Digital Imaging System | Televere Systems | MQB | Class II | |
| K172006 | Alivio Ventricular Catheter and Flusher System (Alivio System) | Alcyone Lifesciences, Inc. | JXG | Class II | |
| K171911 | Medline ReNewal Reprocessed Synthes External Fixation Systems | Medline ReNewal | KTT | Class II | |
| K171850 | Philips CT Big Bore | Philips North America LLC | JAK | Class II | |
| K171467 | BioZorb Marker GOLD / LP Marker GOLD | Focal Therapeutics | IYE | Class II | |
| K171392 | ulrichINJECT CT motion | Ulrich GmbH & Co. KG | IZQ | Class II | |
| K171050 | Geistlich Fibro-Gide | Geistlich Pharma AG | NPL | Class II | |
| K170900 | DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories | Intervene Group Limited | FMF | Class II | |
| K170664 | Odyssey Micro Catheter | Heraeus Medical Components, LLC | DQY | Class II | |
| K170534 | Prolixus Total Knee System | Otis Biotech Co., Ltd. | JWH | Class II | |
| K170071 | SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer | Sleep Group Solutions | BXQ | Class II | |
| K162315 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | MQP | Class II | |
| K161923 | J2A SLA Dental Implant System | KJ Meditech Co., Ltd. | DZE | Class II | |
| K173247 | Surgical Planning Software version 1.1 | Wenzel Spine | LLZ | Class II | |
| K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit | Cerenovus, Inc. | GWM | Class II | |
| K172790 | ER-REBOA Catheter | Prytime Medical Devices, Inc. | MJN | Class II | |
| K172738 | RadiForce RX560, RX560-AR | Eizo Corporation | PGY | Class II | |
| K172620 | SyndesMetrics Syndesmosis Repair System | Mortise Medical, LLC | HTN | Class II | |
| K172083 | Idys™ ALIF System | Clariance-SAS | OVD | Class II | |
| K171534 | SurgicalPreview | Endo Vantage, LLC | PZO | Class II | |
| K171131 | MHC Standard and NRFit Tip Syringes | Mazza Healthcare LLC | FMF | Class II | |
| K170773 | Stryker Universal Mesh | Stryker Corp. | JEY | Class II | |
| K170473 | C2 femoral stem | Lima Corporate S.p.A. | LZO | Class II | |
| K170229 | Dental High-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | EFB | Class I |