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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K071363 | Waterlase and Waterlase Md | Biolase MG LLC | GEX | Class II | |
| K071307 | Invirolink and Inviro Tip Blunt Cannulas, Model 130001, 130501, 140001, 140002, 140003 | Inviro Medical Devices, Inc. | FMI | Class II | |
| K080062 | Oasis Rapid Breast Coil, Model Mr-Ibc-120 and Oasis Rapid Nv Coil, Model Mr-Nvc-120 | FUJIFILM Healthcare Americas Corporation | MOS | Class II | |
| K073510 | Endius Title 2 Poly Axial Spinal System | Endius, Inc. | NKB | Class II | |
| K073490 | Olympus Igg Reagent | OLYMPUS Corporation of the Americas | CFN | Class II | |
| K073489 | Olympus Iga Reagent | OLYMPUS Corporation of the Americas | CFN | Class II | |
| K073487 | Olympus Igm Reagent | OLYMPUS Corporation of the Americas | CFN | Class II | |
| K073435 | Kodak 9000, Kodak 9000 3D | Trophy | MUH | Class II | |
| K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | IZI | Class II | |
| K073149 | Meniscal Cinch | Arthrex GmbH | GAT | Class II | |
| K072981 | Synthes Zero-P | Synthes Spine Co.Lp | OVE | Class II | |
| K072632 | Quanta Plex Celiac Igg Profile | Inova Diagnostics, Inc. | MVM | Class II | |
| K071794 | 15M Monochrome Digital Mammography Lcd Monitor Mdl2123a (Ms51i2) | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K080249 | Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505 | Ultradent Products Inc. | LBH | Class II | |
| K080173 | Star 55 | Larsen & Toubro Limited | MWI | Class II | |
| K080169 | Heartstring III Proximal Seal System | Guidant Corporation, Cardiac Surgery | DXC | Class II | |
| K080160 | Aplio Artida, Model Ssh-880Cv Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | IYN | Class II | |
| K073446 | Grind Guard | Archtek, Inc. | OBR | Unclassified | |
| K073366 | Talking Clinical Electronic Thermometer, Models Dx6623b, Dt1031 and Dt1041 | Shenzhen Dongdixin Technology Co., Ltd. | FLL | Class II | |
| K073347 | Dynesys Top-Loading Spinal System | Zimmer Spine, Inc. | NQP | Class II | |
| K073268 | Biohorizons Internal Implant System | BioHorizons Implant Systems Inc | DZE | Class II | |
| K073243 | LED Pro Seal | Reliance Orthodontic Products, Inc. | EBD | Class II | |
| K073241 | Vascular Pathways Rivs Rapid Intravascular Catheter Start System | Vascular Pathways, Inc. | FOZ | Class II | |
| K073188 | Hypodermic Needle-Pro Edge Safety Device | Abbott Medical | FMI | Class II | |
| K073162 | Safe-Cross(r) Radio Frequency Total Occlusion Crossing System, Safe-Cross(r) Radio Frequency Total Occlusion Crossing | DSM Biomedical, Inc. | DQX | Class II | |
| K073024 | Masimo Rainbow Set Rad 87 Pulse Co-Oximeter and Accessories | Masimo Corporation | DQA | Class II | |
| K072993 | Reusable Headrest with Nasal Seal | Aeiomed, Inc. | BZD | Class II | |
| K072947 | Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters | Clearstream Technologies Ltd. | LIT | Class II | |
| K072942 | Medline Disposable Vaginal Speculum | MEDLINE INDUSTRIES, LP - Northfield | HIB | Class II | |
| K072757 | Dive and Shallow and Grand Dive | Summit to Sea, LLC. | CBF | Class II | |
| K072534 | Bio-Mat 2000 | Richway Intl., Inc. | IRT | Class II | |
| K072228 | Synthetic Vinyl Examination Glove Powder Free (Yellow/white) | Pinnacle Co., Ltd | LYZ | Class I | |
| K071560 | Provent Nasal Dilator, Model Br2 | Ventus Medical, Inc. | OHP | Class II | |
| K071557 | Collawound Hydrogel | Collamatrix Co., Inc. | FRO | Unclassified | |
| K070126 | Occlusion Balloon Catheter | Sentreheart, Inc. | DQY | Class II | |
| K080240 | Challenger/classic Push Button Handpiece | Promident, LLC | EFB | Class I | |
| K080071 | Sidekick Rail Fixator | Wrightmedicaltechnologyinc | KTT | Class II | |
| K073533 | Sanarus V2 Treatment System | Sanarus Medical, Inc. | GEH | Class II | |
| K073438 | Prostim 1000/2000 | Bio Protech, Inc. | GZJ | Class II | |
| K073320 | Cimplicity Spinal System | Spine Smith Partners L.P. | ODP | Class II | |
| K073096 | Anchorage Closure Device | Epitek, Inc. | GAT | Class II | |
| K073003 | Syngo Dual Energy with Extended Functionally | Siemens Medi Cal Solutions, Inc. | JAK | Class II | |
| K072627 | Intuitive Surgical Da Vinci and Da Vinci S Surgical System and Endoscopic Instruments and Endowrist Introducer | Intuitive Surgical, Inc. | NAY | Class II | |
| K072005 | Rk Epidural Needle | Epimed International, Inc. | BSP | Class II | |
| K070761 | Sanatmetal Nails and Pins | Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod. | HSB | Class II | |
| K033484 | Human Heart Valve, Cryovalve Sg | Artivion, Inc. | OHA | Unclassified | |
| K080266 | Well-Pex | Vericom Co., Ltd. | KIF | Class II | |
| K080265 | Denfil Etchant-37 | Vericom Co., Ltd. | EBF | Class II | |
| K080048 | Msk Extreme Mr Scanner, Model Aa5000 | Oni Medical Systems, Inc. | LNH | Class II | |
| K073650 | Fujifilm Unity Speedsuite, Model Cr-Ir 371 | FUJIFILM Healthcare Americas Corporation | KPR | Class II |