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 |
|---|---|---|---|---|---|
| K201122 | Canon non-mydriatic retinal camera CR series | Canon, Inc. | HKI | Class II | |
| K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors | Parcus Medical, L.L.C. | MBI | Class II | |
| K200743 | Vivid E80/ Vivid E90/ Vivid E95 | GE Medical Systems Ultrasound and | IYN | Class II | |
| K200738 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | Microlife Intellectual Property GmbH | DXN | Class II | |
| K200464 | LG Pra. L Derma LD Scalp Care | LG Electronics.Inc | OAP | Class II | |
| K200090 | PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) | PENTAX of America, Inc. | ODG | Class II | |
| K193520 | EVA 15 Insufflator | Palliare | HIF | Class II | |
| K193450 | Pre-Seed™ Fertility Lubricant | Church & Dwight Co., Inc. | PEB | Class II | |
| K201780 | True Tulip System, True M.I.S. System | Innovative Surgical Designs, Inc. | NKB | Class II | |
| K201751 | Pedicle Screw System | Black Box Medical | NKB | Class II | |
| K201699 | Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor | Surgical Instrument and Savings Inc (dba Medline Renewal) | NLF | Class II | |
| K201527 | EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) | Smith & Nephew, Inc. | HRS | Class II | |
| K201406 | Picowon | WONTECH Co., Ltd. | GEX | Class II | |
| K201355 | Endomat Select, IBS Shaver Software, License | Karl Storz SE & Co. KG | HIG | Class II | |
| K201200 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | FET | Class II | |
| K201150 | InMode RF Multi-System | Inmode Ltd. | GEI | Class II | |
| K200869 | Gamma3 System | Stryker Trauma GmbH | HSB | Class II | |
| K200836 | 8ch Flex Suite | Shenzhen RF Tech Co., Ltd. | MOS | Class II | |
| K200654 | Rubicon SA System | Dymedix Diagnostics Inc | MNR | Class II | |
| K200621 | Caption Interpretation Automated Ejection Fraction Software | Caption Health | QIH | Class II | |
| K200513 | DAC Dynamic Active Compression Plate | Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) | HRS | Class II | |
| K200355 | Duranext Abutments | Elegant Dental Corp. | NHA | Class II | |
| K193528 | Empty EVA Bag | Haemotronic, Inc. | KPE | Class II | |
| K193277 | SOMATOM On.site and On.scene | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K192998 | Reprocessed BRK Transseptal Needle | Innovative Health, LLC. | NMK | Class II | |
| K192511 | Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm | Venner Medical (Singapore) Pte Ltd | BTO | Class II | |
| K201690 | Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | DQX | Class II | |
| K201689 | Riptide Aspiration System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | NRY | Class II | |
| K200387 | Ace Medical Surgical Instruments | Ace Medical | HAE | Class II | |
| K200383 | Wiggins Medical Surgical Instruments | Wiggins Medical | HAE | Class II | |
| K193607 | BOBBY Balloon Guide Catheter | Terumo Cardiovascular Systems Corporation | DQY | Class II | |
| K193434 | Vita Lumex Ac | Vita Zahnfabrik GmbH H Rauter & Co | EIH | Class II | |
| K192847 | Autolign | Diorco Co., Ltd. | PNN | Class II | |
| K201349 | Smith+Nephew Arthroscopes | Smith & Nephew, Inc. | HRX | Class II | |
| K201179 | GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable | Medtronic, Inc. | DQA | Class II | |
| K193603 | Benesta Medical Sterilization Tray | Caldera Medical, Inc. | KCT | Class II | |
| K193392 | BioSiCar Silicone Implant | Metalware Technology Corp. | MIB | Class II | |
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set | Cerenovus, Inc. | NRY | Class II | |
| K193022 | Retractable Safety Insulin Syringe | Jiangsu Caina Medical Co., Ltd | MEG | Class II | |
| K192366 | Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation | FPA | Class II | |
| K191875 | Owgels Oxygen Concentrator | Guangzhou Life Light Electronic Technology Co., Ltd. | CAW | Class II | |
| K201798 | myQA iON | IBA Dosimetry GmbH | LHN | Class II | |
| K201672 | Signia Stapler (with new software) | Medtronic, Inc. | GDW | Class II | |
| K201488 | Rover | Micro-X Ltd. | IZL | Class II | |
| K201465 | SuRgical Planner (SRP) BrainStorm | Surgical Theater Inc | LLZ | Class II | |
| K201365 | True 3D Viewer | Echopixel, Inc. | LLZ | Class II | |
| K201364 | LINK TrabecuLink Femoral Cones | Waldemar Link GmbH & Co. KG | MBH | Class II | |
| K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28 | HSB | Class II | |
| K201198 | S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable | Smith & Nephew, Inc. | GCJ | Class II | |
| K201098 | Ambu Duodeno System | Ambu Innovation GmbH | FDT | Class II |