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 |
|---|---|---|---|---|---|
| K973967 | Al-47 (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Tinted, Lathe-Cut from Lens Blank) | Alden Optical Labs., Inc. | LPL | Class II | |
| K973847 | Al-47 Toric (Isofilcon) Soft (Toric) Daily Wear Contact Lens | Martin Dalsing | LPL | Class II | |
| K973749 | Frag Commander | Scieran Technologies, Inc. | HQC | Class II | |
| K973566 | Sowell Patented Non-Precious Metal Alloy | C.K. International Trading | EJH | Class II | |
| K973528 | Sunglasses | Jeou Jeou Long Industrial Co., Ltd. | HQY | Class I | |
| K973510 | Duploject (0.5/1.0 Ml, 2.0 Ml, 5.0 Ml) | Immuno-U.S., Inc. | FMF | Class II | |
| K973485 | Clearview Blower/mister | Dlp, Inc. | FQH | Class II | |
| K973472 | 3M Cdi H/s Cuvettes with Heparon Treatment | 3M Healthcare | DRY | Class II | |
| K973468 | Model Irc 1199 Scout Nebulizer | Invacare GmbH | CAF | Class II | |
| K973439 | Endo Analyzer, Model 8005 | Sybron Dental Specialties, Inc. | EAT | Class II | |
| K973412 | Natural-Knee II Constrained Knee System | Sulzer Orthopedics, Inc. | JWH | Class II | |
| K973406 | Osteonics Series 7000 Total Knee Augmented Femoral Component | Osteonics Corp. | JWH | Class II | |
| K973092 | Stae | Southern Dental Industries, Inc. | KLE | Class II | |
| K973091 | Wave | Southern Dental Industries, Inc. | EBF | Class II | |
| K973089 | Freedom | Southern Dental Industries, Inc. | EBF | Class II | |
| K963518 | Cobe Optima Xp Hollow Fiber Membrane Oxygenator | LivaNova USA, Inc. | DTZ | Class II | |
| K974047 | Accuwell Phenylalanine Assay | Neometrics, Inc. | JNB | Class II | |
| K974003 | Alanine Aminotransferase-Sl Assay Catalogue Number 318-10, 318-30 | Sekisui Diagnostics P.E.I. Inc. | CKA | Class I | |
| K973882 | El-B2gp1scr | Theratest Laboratories, Inc. | MSV | Class II | |
| K973842 | Carbon Fiber Conformal Couch Top | Medtec LLC | IXQ | Class II | |
| K973826 | Sphincterotome | Boston Scientific Corporation | KNS | Class II | |
| K973630 | Cp Breast Array Coil/magnetom Harmony/symphony System | Siemens Medical Solutions USA, Inc. | MOS | Class II | |
| K973616 | Troponin I Assay for the Bayer Immuno 1 System | Bayer Corp. | MMI | Class II | |
| K973433 | Steri-Oss 3.25 Mm Replace(titanium Plasma Sprayed) Dental Implant | Steri-Oss, Inc. | DZE | Class II | |
| K973423 | Steri-Oss 3.25 Mm Replace(hydroxyapatite-Coated)dental Implant | Steri-Oss, Inc. | DZE | Class II | |
| K973421 | Imageshare Computed Radiography Acquisition Station And/or Software(2100{sikarus X86}/(1500{windows Nt} | Dejarnette Research Systems | LMD | Class I | |
| K973385 | Oval Shapes | Technical Products, Inc. | HXA | Class II | |
| K973384 | Ethicon Non-Stick Bipolar Forceps | Ethicon, Inc | GEI | Class II | |
| K973355 | Advantage 3000 | Advantage Medical Division of Cme Telemetrix | IKN | Class II | |
| K972925 | Access Radiology (Framewave) Teleradiology Image Acquisition and Distribution System with Picture and Archiving Communic | Access Radiology Corp. | LMD | Class I | |
| K972790 | The Theratest El-B2gp1 (Igm, Igg, Iga) and El-B2gp1scr | Theratest Laboratories, Inc. | MSV | Class II | |
| K972228 | Meridian Titanium Femoral Stems | Howmedica Corp. | LZO | Class II | |
| K963982 | Acist Angiographic Injector | Invasatec | DXT | Class II | |
| K973976 | Epic-Flo | Parkell, Inc. | EBF | Class II | |
| K973899 | Unifine Pentips | Owen Mumford USA, Inc. | FMI | Class II | |
| K973782 | Aquasil Xlv Smart Wetting Impression Material | Dentsply Intl. | ELW | Class II | |
| K973771 | Dental/surgical Drills, Burs, Taps | ZimVie US Corp LLC | DZE | Class II | |
| K973703 | Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound Drain | Medtronic, Inc. | GBX | Class I | |
| K973509 | Kendall Curasorb Zn + Mg Alginate Wound Dressing | Kendall Healthcare Products Co. Div.Of Tyco Health | KMF | Class I | |
| K973491 | Mechanical Folding Wheel Chair | Heartway Medical Products Co., Ltd. | IOR | Class I | |
| K973411 | Digmi-2000 (Gsi Internal Reference)/ld2800 (Marketing Name) | General Scanning, Inc. | LMA | Class II | |
| K973354 | Sharplan Epitouch Alexandrite Laser System (5000) | Sharplan Lasers, Inc. | GEX | Class II | |
| K973206 | Sterling Diagnostic Imaging Direct Radiography | Sterling Diagnostic Imaging, Inc. | MQB | Class II | |
| K973146 | Mentor Super Absorbent Drape | Mentor Ophthalmics, Inc. | KKX | Class II | |
| K972767 | Candela Gentlelase Gl Dermatological Vascular Lesion Laser | Candela Corporation | GEX | Class II | |
| K972649 | Cardiocall Cardiac Event Recorder | Reynolds Medical, Ltd. | DXH | Class II | |
| K972016 | Autimo 2.5-D and Autimo 3-D | C.L. Mcintosh & Assoc., Inc. | IXI | Class II | |
| K971920 | Gown Poly Reinforced Large(product No.900-522)/(Reorder No. 0522) | Customed, Inc | FYA | Class II | |
| K971824 | Reach Femoral Hip Component | Zimmer GmbH | LPH | Class II | |
| K971681 | Smc Femoral Hip Component | Whiteside Biomechanics, Inc. | JDI | Class II |