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 |
|---|---|---|---|---|---|
| K951384 | V-Cath Percutaneous Introducer Kit | Hdc Corp. | KZH | Class II | |
| K951350 | Musclesense Electromyography Device | Smith and Nephew Donjoy, Inc. | HCC | Class II | |
| K946247 | Igfbp-3; Insulin-Like Growth Factor Binding Protein-3 | Nichols Institute | CFL | Class I | |
| K946021 | Vinyl Powder-Free Examination Gloves | Wilson Glove Products Co., Ltd. | LYZ | Class I | |
| K945390 | Citation Delta Scope | Citation Medical Corp. | HRX | Class II | |
| K945111 | Dynapulse 5000A (Dp5000a) | Pulse Metric, Inc. | DXN | Class II | |
| K915402 | Ew-10 and Ew-20 | Olympus Corp. | FEB | Class II | |
| K952600 | Evt-5000Bx | U.S. Table, Inc. | INQ | Class I | |
| K952543 | Graftologer Pgh & Acl Reconstruction Instrument Set | Neoligaments, Ltd. | HWE | Class I | |
| K952500 | Compseal | Jeneric/Pentron, Inc. | EBF | Class II | |
| K952493 | Fluorecord Model 762 | Syracuse Scientific, Inc. | JAA | Class II | |
| K952446 | Tongue Clean | 1-800-Tongues, Inc. | LCN | Class I | |
| K952431 | Spectrum | Freedom Designs Inc | IOR | Class I | |
| K952423 | Cu-100Rlc Light Cure Unit, Document No.a715676 | Rolence Enterprise Co., Ltd. | EBZ | Class II | |
| K952359 | The Hill Adjustable Ha90c | Hill Laboratories | INQ | Class I | |
| K952358 | The Hill Adjustable P.t. Mobilization Table | Hill Laboratories | INQ | Class I | |
| K952356 | The Hill Adjustable Counterstrain Table | Hill Laboratories | INQ | Class I | |
| K952355 | The Hill Adjustable 90Md | Hill Laboratories | INQ | Class I | |
| K952217 | Mitraflex Wound Dressing Wet-Stick | Polymedica Industries, Inc. | MGP | Unclassified | |
| K952168 | Titanium Mandibular Fracture System | Medicon Co., Ltd. | JEY | Class II | |
| K952121 | 3M Resin Cement | 3M Medical Products Group | EMA | Class II | |
| K952120 | Torque Limiter | Steri-Oss, Inc. | DZE | Class II | |
| K952071 | Ultec Thin Hydrocolloid Dressing | Sherwood Medical Co. | MGP | Unclassified | |
| K952069 | Mechanical Wheelchair | Grand Seating King Corp. | IOR | Class I | |
| K951955 | Cardon Physical Therapy Table Model:r40194 | Cardon Rehabilitation Products, Inc. | INQ | Class I | |
| K951720 | Scimed Expo Angiographic Catheter | Scimed Life Systems, Inc. | DQO | Class II | |
| K951649 | Model #801Ge1500 Pediatric Array Coil | Medic, Inc. | LNH | Class II | |
| K951621 | J & S Wheelchairs Models 500, 500B, 502, 503, 504 and 500T | J&S Associates | IOR | Class I | |
| K951607 | Sureflex Files | Dentsply Intl. | EKJ | Class I | |
| K951508 | Stainless Steel Greenfield Vena Cava Filter with 24F Introducer System | Boston Scientific Corporation | DTK | Class II | |
| K951415 | Luhr Pan Fixation System Condensed Straight Plate, Y Plates and 1.5Mm Bone Screw | Howmedica Corp. | HRS | Class II | |
| K951307 | Baxter Trek *14 Intermediate and Support Guidewires | Baxter Healthcare Corporation | DQX | Class II | |
| K951271 | Vs11 Sf | Metalor Dental USA Corp. | EJT | Class II | |
| K951248 | Braun Pta Balloon Catheter | B.Braun Medical, Inc. | LIT | Class II | |
| K950906 | Lesinski Surgical Ear Dressing | Microtek Medical LLC | EFQ | Unclassified | |
| K950782 | Medi-Trac EEG Electrode | Graphic Controls Corp. | GXY | Class II | |
| K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | MNH | Class II | |
| K950652 | Osteotech Navicular and Cancellous Cannulated Screws | Osteotech Inc | HWC | Class II | |
| K950357 | Survival Kit | Opportunity Resources, Inc. | LYY | Class I | |
| K950216 | Scimed Choice Pt Plus(rm) Ptca Guide Wire | Scimed Life Systems, Inc. | DQX | Class II | |
| K945781 | Webb-Morley Spine System | Electro-Biology, Inc. | KWP | Class II | |
| K945690 | Backcycler Cpm(tm) | Ergomedics, Inc. | BXB | Class I | |
| K945687 | Rounded Cannulated Inside-Out (Rci) Acl Screw | Smith and Nephew Donjoy, Inc. | HWC | Class II | |
| K944935 | Dynatron 250 | Dynatronics Corp. | IPF | Class II | |
| K944871 | Lmd Giardia Antigen Detection Assay | Lmd Laboratories | MHI | Class II | |
| K944737 | Isola Spine System | Acromed Corp. | MNH | Class II | |
| K943933 | Saxon Gold Ultra Spermicidal Rainbow Condom | Aladan Corp. | HIS | Class II | |
| K942697 | Trojan Polyurethane Condom | Carter Products | MOL | Class II | |
| K942681 | Filtryzer | Toray Industries (America), Inc. | KDI | Class II | |
| K942256 | The Hill Adjustable Extend-R Table | Hill Laboratories | INQ | Class I |