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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K262722 | Primal K-Wire (P99-193-1410) | Paragon 28, Inc. | HTY | Class II | |
| K262013 | Kiba CTO Crossing Catheter | Reflow Medical, Inc. | PDU | Class II | |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) | Ortler Global Tibbi Gerecler Anonim Sirketi | HRS | Class II | |
| K261582 | Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | NUV | Class II | |
| K261378 | Rayvolve AZchest | AZmed | QBS | Class II | |
| K261176 | Zoom 4S Catheter | Imperative Care, Inc. | QJP | Class II | |
| K260617 | Tigertriever 13 Ultra Revascularization Device | Rapid Medical Ltd. | NRY | Class II | |
| K260517 | Automatic Core Biopsy Instrument | Zhejiang Curaway Medical Technology Co., Ltd. | KNW | Class II | |
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart Display | GE Healthcare Finland Oy | MHX | Class II | |
| K260203 | Fule Vertebroplasty Balloon Catheter | Beijing Fule Science & Technology Development Co., Ltd. | HRX | Class II | |
| K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) | Roche Molecular Systems, Inc. | PGX | Class II | |
| K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) | Roche Molecular Systems, Inc. | OZN | Class II | |
| K254261 | Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) | Cell Store (Beijing) Biotechnology Co., Ltd. | MQL | Class II | |
| K253954 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | QRY | Class II | |
| K253630 | Mpact 3D Metal Foam | Medacta International S.A. | LPH | Class II | |
| K262744 | GenesisX RMN | Stereotaxis, Inc. | DXX | Class II | |
| K262677 | Iconix Knotless T | Riverpoint Medical | MBI | Class II | |
| K262654 | Dexus Prosthetic System (MSL2, MSR2) | Zhejiang Qiangnao Technology Co.,Ltd | GXY | Class II | |
| K262268 | Optiflow Oxygen Kit (AA484J) | Fisher and Paykel Healthcare Limited | BTT | Class II | |
| K262104 | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) | Ram.Shaw Pte., Ltd. | LRK | Class II | |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | GEX | Class II | |
| K261802 | Glidewell™ Denture Base Resin | Prismatik Dentalcraft, Inc. | EBI | Class II | |
| K261360 | EasyCare Tx 2 | Resmed Corp | MOD | Class II | |
| K260870 | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | Gebauer Company | MLY | Unclassified | |
| K260856 | Disposable Distal Attachment D-201-13404 | Olympus Medical Systems Corporation | FDS | Class II | |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500 | Olympus Medical Systems Corporation | FDS | Class II | |
| K260751 | 35 Helix Guidewire | Piraeus Medical, Inc. | MOF | Class II | |
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP) | Berkeley Advanced Biomaterials | KGN | Unclassified | |
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | NBW | Class II | |
| K260481 | Gc85a | Samsung Electronics Co., Ltd. | KPR | Class II | |
| K260401 | Evis Eus Ultrasound Bronchofibervideoscope Olympus Bf-Ucp190f (Bf-Ucp190f) | Olympus Medical Systems Corporation | PSV | Class II | |
| K253859 | Scarlet Pro (Scarlet Pro) | VIOL Co., Ltd. | GEI | Class II | |
| K262595 | VariLift-C Cervical Interbody Fusion System | Wenzel Spine, Inc. | ODP | Class II | |
| K262581 | GraftGun Universal Graft Delivery System (GDS®) | SurGenTec, LLC | FMF | Class II | |
| K261394 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus) | JOYTECH Healthcare Co., Ltd. | DXN | Class II | |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope System | Boston Scientific Corporation | FGB | Class II | |
| K261142 | Ponto 5 Mini; Ponto 5 Superpower | Oticon Medical AB | MAH | Class II | |
| K260972 | OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor | Sony Corporation | GCJ | Class II | |
| K260811 | Heartvue.Proton | Heartvue.ai, Inc. | QIH | Class II | |
| K260733 | MRIA Radiation Therapy Information System (MRIA) | Manteia Technologies Co., Ltd. | IYE | Class II | |
| K260407 | Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns | Principle & Will Co., Ltd. | FYA | Class II | |
| K254103 | HOPKINS Telescopes for Arthroscopy | Karl Storz SE & CO. KG | HRX | Class II | |
| K253877 | StimTrial Neuromodulation System | Bioventus, LLC | GZF | Class II | |
| K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279) | Maquet Critical Care AB | PIF | Class II | |
| K262631 | Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) | SteriLance Medical (Suzhou), Inc. | QRK | Class II | |
| K261747 | Report Studio | Beacon Biosignals, Inc. | OLV | Class II | |
| K261719 | Promisemed X-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | FMI | Class II | |
| K261595 | Ceevra Reveal 4 | Ceevra, Inc. | QIH | Class II | |
| K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal) | Guilin Kevin Peter Technology Co., Ltd. | KIF | Class II | |
| K254304 | iNOS intraoral biosensor | Achaemenid, LLC | PLC | Class II |