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 |
|---|---|---|---|---|---|
| K182774 | STOP U (Packed Black USA), STOP U (Packed White USA) | Pollogen Ltd | PAY | Class II | |
| K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | Quidel Cardiovascular Inc. | DKZ | Class II | |
| K182703 | EntericBio Dx Assay | Serosep, Ltd. | PCH | Class II | |
| K182658 | Bioliner | Five Star Orthodontic Lab & Supply | NXC | Class II | |
| K182638 | Hailie Sensor | Adherium (Nz), Ltd. | CAF | Class II | |
| K191209 | Aneroid Type Blood Pressure Kit | Dongguan Mars Medical Products Co., Ltd. | DXQ | Class II | |
| K191049 | Stryker MIS and Footed Attachments | Stryker Corp. | HBE | Class II | |
| K190913 | QLAB Advanced Quantification Software 13 | Philips Health Care | LLZ | Class II | |
| K183578 | Torpedo Gelatin Foam | Biosphere Medical, S.A. | KRD | Class II | |
| K183385 | NanoKnife System | Boston Scientific Corporation | OAB | Class II | |
| K182667 | Med-link Temperature Probes | Shenzhen Med-Link Electronics Tech Co.,Ltd | FLL | Class II | |
| K182493 | Bovine Pericardial Tissue Patch | Tisgenx, Inc. | FTM | Class II | |
| K191368 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. | QEW | Class II | |
| K190936 | Q-Switched Nd: YAG Laser System | Shanghai Apolo Medical Technology Co.,Ltd. | GEX | Class II | |
| K190684 | LxHA PEEK Lateral IBF System | Innovasis, Inc | MAX | Class II | |
| K190663 | Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 | Pajunk GmbH Medizintechnologie | BSN | Class II | |
| K190662 | MRI Compatibility for Existing Straumann Dental Implant Systems | Straumann USA, LLC | DZE | Class II | |
| K190121 | Ids Shbg | Immunodiagnostic Systems Ltd. | CDZ | Class I | |
| K182695 | Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter | Cook Incorporated | EYB | Class II | |
| K182524 | GALILEO Spine Alignment Monitoring System | Mirus, LLC | OLO | Class II | |
| K190010 | Penumbra System Reperfusion Catheter JET 7 | Penumbra Inc. | NRY | Class II | |
| K191387 | ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube | Envizion Medical, Ltd. | KNT | Class II | |
| K191318 | AEQUALIS FLEX REVIVE Shoulder System | TORNIER Inc. | KWS | Class II | |
| K191299 | Silhouette Featherlift / Silhouette Lift | Sinclair Pharma US, Inc. | GAW | Class II | |
| K190700 | Electrodes Pad | Shenzhen Bestpad Technology Development Co., Ltd | GXY | Class II | |
| K190414 | Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV | Moss Tubes, Inc. | PIF | Class II | |
| K190172 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | Stryker Corp. | HBE | Class II | |
| K183566 | CLARITY II Laser System | Lutronic Corporation | GEX | Class II | |
| K183431 | Medline Digital Rectal Thermometer Sheath | MEDLINE INDUSTRIES, LP - Northfield | FLL | Class II | |
| K183263 | UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope | Unipack Medical Corporation | PEM | Class II | |
| K183219 | Trio-CT Triple Lumen Catheter | Medical Components, Inc. | NIE | Class II | |
| K183195 | Vivo | Catheter Precision, Inc. | DQK | Class II | |
| K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | Corinth Medtech, Inc. | FJL | Class II | |
| K191089 | Edwards Pressure Cable | Edwards Lifesciences LLC | DQK | Class II | |
| K191036 | SyMRI | Syntheticmr AB | LNH | Class II | |
| K191005 | ProLift® Expandable System | Life Spine | MAX | Class II | |
| K190667 | Sonopet iQ Sterilization Tray | Paragon Medical Inc. | KCT | Class II | |
| K190424 | HealthICH | Zebra Medical Vision, Ltd. | QAS | Class II | |
| K190228 | Transcranial Doppler Ultrasound System | Shenzhen Delica Medical Equipment Co., Ltd. | IYN | Class II | |
| K190133 | Full Automatic (NIBP) Blood Pressure Monitor-HL158UB | Health & Life Corporation | DXN | Class II | |
| K190117 | Fiberoptix IAB | Arrow International LLC (subsidiary of Teleflex Incorporated) | DSP | Class II | |
| K183564 | Electrosurgical Generator | Fulwell LLC | GEI | Class II | |
| K183513 | XenoSure Dura Biologic Patch | LeMaitre Vascular Inc. | GXQ | Class II | |
| K183460 | ClariCT.AI | Claripi Inc. | LLZ | Class II | |
| K183363 | Treace Medical Concepts (TMC) Snap-Off Screw System | Treace Medical Concepts, Inc. | HWC | Class II | |
| K182608 | Oyster ACIF Cage | Silony Medical GmbH | ODP | Class II | |
| K182159 | Strome-Blitzer Cytology Balloon | Adn International, LLC | EOX | Class II | |
| K181965 | Restore Toothpaste | Dr. Collins, Inc. | LBH | Class II | |
| K181514 | SeraQuest HSV Type 2 Specific IgG | Quest International, Inc. | MYF | Class II | |
| K191331 | Life Sensor Cardiac Monitor | Braveheart Wireless, Inc. | DRG | Class II |