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 |
|---|---|---|---|---|---|
| K170093 | AcceleDent Optima | Orthoaccel Technology, Inc. | OYH | Class II | |
| K163349 | MIS V3 Conical Connection Dental Implant System | MIS Implants Technologies Ltd. | DZE | Class II | |
| K163140 | SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System | Gemss Medical Systems Co., Ltd. | OWB | Class II | |
| K163065 | T3 Software | Etiometry Inc. | MWI | Class II | |
| K162603 | Masimo O3 Regional Oximeter System | Masimo Corporation | MUD | Class II | |
| K162526 | Creatine Kinase-MB | Roche Diagnostics GmbH | JHW | Class II | |
| K162448 | White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter | Cook Incorporated | DQO | Class II | |
| K171253 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead | Medtronic, Inc. | LDF | Class II | |
| K171238 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy-America, Inc. | OWN | Class II | |
| K171170 | M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws | Medacta International SA | NKB | Class II | |
| K170944 | LCD Monitor (MD310C, MD310G, MD210G) | Benq Corporation | PGY | Class II | |
| K170892 | Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL | Liofilchem S.r.l. | JWY | Class II | |
| K170611 | SETx Pedicle Screw System | Xenco Medical LLC | NKB | Class II | |
| K170597 | PicoWay Laser System | Syneron Candela Corporation | GEX | Class II | |
| K170558 | revogene | Genepoc, Inc. | OOI | Class II | |
| K170557 | GenePOC GBS LB | Genepoc, Inc. | NJR | Class I | |
| K170486 | CATHTONG II PICC Catheter | L & z US, Inc. | LJS | Class II | |
| K170259 | TruAbutment DS | TruAbutment Inc. | NHA | Class II | |
| K170242 | MultiGen™ 2 RF Generator System | Stryker Corp. | GXD | Class II | |
| K171194 | As-10, Cxdi-401Rf | Canon, Inc. | OWB | Class II | |
| K170891 | Mako Partial Knee Application | Mako Surgical Corp. | OLO | Class II | |
| K170779 | Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein | Terang Nusa (Malaysia) Sdn. Bhd. | LYY | Class I | |
| K170603 | Tao Brush I.U.M.C. Endometrial Sampler | Cook Incorporated | HFE | Class II | |
| K170514 | Central Monitoring System | Guangdong Biolight Meditech Co., Ltd | MHX | Class II | |
| K170349 | RA-308 Excimer Laser System, Excimer Laser Catheter | Ra Medical Systems,Inc | PDU | Class II | |
| K170306 | FIBERGRAFT BG Putty Bone Graft Substitute | Prosidyan, Inc. | MQV | Class II | |
| K170290 | Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr | Shen Wei (USA), Inc. | LZA | Class I | |
| K170287 | Dental Implants OKTAGON Bone Level Tapered Design | Hager & Meisinger GmbH | DZE | Class II | |
| K170172 | UNiD Spine Analyzer | Medicrea International | LLZ | Class II | |
| K163618 | INDIGO Aspiration System | Penumbra Inc. | QEX | Class II | |
| K163257 | VitreOx Anti-fog Solution | Sio2 Nanotech, LLC | OCT | Class II | |
| K163244 | truFreeze System | CSA Medical | GEH | Class II | |
| K163197 | Cook Holmium Laser Fiber | Cook Incorporated | GEX | Class II | |
| K163196 | ACTION II Laser System | Lutronic Corporation | GEX | Class II | |
| K163172 | 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 | |
| K163071 | vascuCAP | Elucid Bioimaging | LLZ | Class II | |
| K162463 | Matrix Data Management System | Global Instrumentation Corp. | DXN | Class II | |
| K162433 | GCE Zen-O Portable Oxygen Concentrator | Oxus, Inc. | CAW | Class II | |
| K162409 | Gems Vitrification Set, Gems Warming Set | GENEA BIOMEDX Pty Ltd. | MQL | Class II | |
| K170489 | Skylit Phototherapy System | Skylit Medical | FTC | Class II | |
| K163673 | Fortilink™-C with TETRAfuse™ 3D Technology | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | ODP | Class II | |
| K163658 | ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay | Siemens Healthcare Diagnostics Inc. | CEW | Class II | |
| K163430 | Prontosan Wound Gel | B.Braun Medical, Inc. | FRO | Unclassified | |
| K163090 | Plasma Edge System | Chirurgie Innovation | FAS | Class II | |
| K162598 | HAPI Seal | Bisco Inc | EBC | Class II | |
| K161833 | Latex Examination Glove Powder Free | Careglove Global Sdn Bhd | LYY | Class I | |
| K171348 | Pinpoint GT Needle Guide Kits | C.R. Bard Inc | ITX | Class II | |
| K170989 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | NKB | Class II | |
| K170586 | Strep B Carrot Broth One-Step | Hardy Diagnostics | PQZ | Class I | |
| K170282 | Smith & Nephew VISIONAIRE Adaptive Guides | Smith & Nephew, Inc. | JWH | Class II |