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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K133521 | Aze Phoenix Software | Aze, Ltd. | LLZ | Class II | |
| K133345 | Reveel Endoscopic Retractor | Retraction Limited | GCJ | Class II | |
| K133340 | Spineworks Anterior Lumbar Device | Spineworks, LLC | MAX | Class II | |
| K132596 | Proposed Optimus | Custom Spine, Inc. | OVD | Class II | |
| K132478 | Air-Flow Handy 3.0 | E.M.S. - Electro Medical Systems SA | EFB | Class I | |
| K132312 | Renovis Tesera Trabecular Technology (T3) Acetabular Shell System | Renovis Surgical Technologies, LLC | LPH | Class II | |
| K132138 | Rhythmlink Disposable Concentric Stimulating Probe | Rhythmlink International, LLC | PDQ | Class II | |
| K131906 | Scanwave Pen (with Light Gray Cord), Scanwave Pen (with Medium Gray Cord), Scanwave Pen (with Dark Gray Cord), Scanwave | Satelec-Acteon Group | EBZ | Class II | |
| K131883 | Audicor Cpam with Sdb (Accelerometer Based) | Inovise Medical, Inc. | MNR | Class II | |
| K131734 | All-Bond Universal Sc (Not Finalized) | Bisco Inc | KLE | Class II | |
| K122377 | Powder Free Vinyl Examination Gloves | Shu Tong Xinghua Co., Ltd. | LYZ | Class I | |
| K122176 | Powdered Vinyl Examination Gloves | Shu Tong Xinghua Co., Ltd. | LYZ | Class I | |
| K140696 | Streamline Tl Spinal Fixation System | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | NKB | Class II | |
| K140648 | St Aia-Pack C-Peptide II Calibrator Set | Tosoh Bioscience Inc | JIT | Class II | |
| K140473 | Dualguard | Flexicare Medical Ltd. | CCK | Class II | |
| K140339 | Vital Sync Informatics Manager & Virtual Patient Monitoring Platform | Medtronic, Inc. | MWI | Class II | |
| K140042 | 1.5Mm Hydro Expandable Lemaitre Valvulotome | LeMaitre Vascular Inc. | MGZ | Class II | |
| K133903 | Bio-Probe Transducer (Adult) | Medtronic, Inc. | DPT | Class II | |
| K133578 | Reprocessed Ligasure Blunt Tip Laparoscopic Sealer/divider | Stryker Sustainability Solutions | NUJ | Class II | |
| K133238 | Contour I V3.1 System | Syneron Medical, Ltd. | OHV | Class II | |
| K133045 | Element Tm Lite Blood Glucose Monitoring System | Infopia Co, Ltd. | NBW | Class II | |
| K132934 | Multix Select Dr | Siemens Medi Cal Solutions, Inc. | KPR | Class II | |
| K132825 | Retromta-Orthomta II | BioMTA | KIF | Class II | |
| K132290 | Surgicase Orthopaedics System, Surgicase Connect, Surgicase Guides | Materialise N.V. | PBF | Class II | |
| K132284 | Vectra Neo Clinical Therapy System | DJO, LLC | IPF | Class II | |
| K132208 | Ontex and Others Proprietary Names | Ontex Bvba | HIL | Class II | |
| K131944 | Ieeg | Jordan Neuroscience, Inc. | OMC | Class II | |
| K131902 | Pentax Video Upper G.i. Scopes (Eg Family) | PENTAX of America, Inc. | FDS | Class II | |
| K131028 | Pentax Video Bronchoscopes (Eb Family) | PENTAX of America, Inc. | EOQ | Class II | |
| K140609 | Reliatack Articulating Reloadable Fixation Device with Standard Purchase Absorble Tacks | Medtronic, Inc. | GDW | Class II | |
| K140047 | Lexiconture Mechanical Dilator Sheath Set | Spectranetics Corp. | DRE | Class II | |
| K134008 | Md-Flex Heavy Body | Meta Biomed Co., Ltd. | ELW | Class II | |
| K133837 | Viora V-Total | Viora, Ltd. | GEX | Class II | |
| K133716 | Trc-Paste | Km Corporation | KIF | Class II | |
| K133285 | Stryker Temporary Condylar Prosthesis | Stryker Corp. | NEI | Class II | |
| K133212 | Zeltiq Coolsculpting System | Zeltiq Aesthetics Inc | OOK | Class II | |
| K133182 | Htfx-222 | GC America Inc. | EBF | Class II | |
| K132401 | Mega Isq | Osstell AB | EKX | Class I | |
| K132009 | Cmos Video Nasopharyngoscope System | Schoelly Fiberoptic, GmbH | EOB | Class II | |
| K131855 | Pentax Video Colonoscopes (Ec Family) | PENTAX of America, Inc. | FDF | Class II | |
| K131563 | Subq It! Bioabsorbable Skin Closure System | Opus KSD, Inc. | GDW | Class II | |
| K131098 | Emergency Portable Ventilator | Allied Medical LLC | BTL | Class II | |
| K123555 | Kangaroo Feeding Tubes with Iris Technology | Medtronic, Inc. | KNT | Class II | |
| K140482 | Mandrel Guidewire | Lake Region Medical | OCY | Class II | |
| K140089 | Cr3 Keyless Split Sample Cup(opi-Bzo) | Guangzhou Wondfo Biotech Co., Ltd. | DJG | Class II | |
| K133949 | Powder Free Nitrile Patient Examination Glove,blue and Orange Colored,non-Sterile Tested for Use with Chemotherapy Drugs | Top Calibre Sdn Bhd | LZA | Class I | |
| K133554 | Surgical Light Handle Cover | Microtek Medical, Inc. an Ecolab Company | FTA | Class II | |
| K133366 | Orthros Posterior Stabilization System | Camber Spine | NKB | Class II | |
| K132423 | The Gynocular | Gynius AB | HEX | Class II | |
| K130531 | Ultrafuse | Baxter Healthcare Corporation | MQV | Class II |