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 |
|---|---|---|---|---|---|
| K011128 | Nichols Advantage Direct Renin (Calibrators, Calibration Verifiers, Controls, and Sample Diluent) | Nichols Institute Diagnostics | CIB | Class II | |
| K010612 | Vectorvision Knee | Brainlab, Inc. | HAW | Class II | |
| K010450 | Liver Tamponade Balloon | Cook Inc. | NGU | Class II | |
| K010431 | Lead-Lok Reusable TENS/ Nmes Electrodes | Lead-Lok, Inc. | GXY | Class II | |
| K003988 | Uroscope, Artes Medical, USA | Artes Medical USA, Inc. | FAJ | Class II | |
| K002352 | Jms A.v. Fistula Needle Set Accordion Type | JMS Co., Ltd. | FIE | Class II | |
| K012573 | Castle 400Hc/500hc Series Steam Sterilizer, Models 422Hc, 433Hc, 522Hc, and 533Hc | Getinge/Castle, Inc. | FLE | Class II | |
| K012440 | Modification to Clearfil Liner Bond 2V | Kuraray Medical, Inc. | KLE | Class II | |
| K012438 | Modification to Panavia 21 | Kuraray Medical, Inc. | EMA | Class II | |
| K012342 | Ams Soft-Tissue Approximation System | American Medical Systems, Inc. | FZP | Class II | |
| K012180 | A-Wear | Bisco Inc | EBF | Class II | |
| K011981 | Mhs 5000 | Micro Health Systems, Inc. | LHQ | Class I | |
| K011820 | Dentorium Convertible Acrylic | Nats Corp. | EBI | Class II | |
| K011790 | Microcruiser Plus Introducer Set | Medical Device Technologies, Inc. | DYB | Class II | |
| K011774 | R120 Modular Total Hip System | Osteoimplant Technology, Inc. | JDI | Class II | |
| K011763 | Omnidos | Scanditronix Medical AB | IYE | Class II | |
| K010935 | Britesmile Barrier Material | Britesmile, Inc. | EIE | Class I | |
| K002394 | Jms Apheresis Needle Set Accordion Type | JMS Co., Ltd. | FMI | Class II | |
| K012799 | Es-2000 Shape Select Electrosurgical Scalpel | Senorx, Inc. | GEI | Class II | |
| K012541 | Modification To:fastix Thc/coc Drug Screen Dipstick Test, Fastix Thc/coc/met Drug Screen Dipstick Test, Fastix Opi/met | Branan Medical Corp. | LDJ | Class II | |
| K012468 | Modification to N/t Protein Control Sl | Siemens Healthcare Diagnostics Inc. | JJY | Class I | |
| K012436 | Modification to Alloy Primer | Kuraray Medical, Inc. | KLE | Class II | |
| K012432 | Modification to Clearfil Photo Bond | Kuraray Medical, Inc. | KLE | Class II | |
| K012405 | Extrude Modified | Sybron Dental Specialties, Inc. | ELW | Class II | |
| K012392 | Disposable Surgical Extension Cable, Model 4255 and Model 4260 | Pace Medical | DSA | Class II | |
| K012177 | Ventview, Model 8414095 | Drager Medizintechnik GmbH | CBK | Class II | |
| K011868 | Enteral Expres Pump Unit, Enteral Expres Giving Sets | Debio Tech SA | LZH | Class II | |
| K011854 | Tokuyama M-Bond | Tokuyama America Inc. | EMA | Class II | |
| K011785 | Novel Print Cyan Alginates | Manufacturera Dental Continental | ELW | Class II | |
| K011674 | Dc - Cristal | Austenal, Inc. | EIH | Class II | |
| K010621 | Accu-Space Absorbable Seeding Spacers | Cp Medical | KXK | Class II | |
| K010424 | Nexan System, Model Nx-301 | Nexan, Ltd. | MWI | Class II | |
| K003548 | Padpro System Defibrillator Electrode Adapters | Padpro, LLC | MKJ | Class III | |
| K012663 | Easy Moving Mobile X-Ray Unit (Model Sm-HF) | Sedecal USA, Inc | IZL | Class II | |
| K012530 | Aa-1 System | Neurovision, Inc. | HJT | Class I | |
| K012476 | Monarch, Transshaping Gastrostomy Tube Model 9-2010 | Applied Medical Technology Inc | KNT | Class II | |
| K012317 | Coalescent Surgical U-Clip | Coalescent Surgical | FZP | Class II | |
| K012296 | Human Igg Subclass Liquid Reagent Kits, Product Code Lk001.t | The Binding Site | CFN | Class II | |
| K012292 | Human Igg Subclass Liquid Reagent Kits, Product Code Lk001.tb | The Binding Site | CFN | Class II | |
| K012162 | Stryker Plating System Basic Fragment Set | Howmedica Osteonics Corp | HRS | Class II | |
| K011912 | Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000 | TORNIER Inc. | MBI | Class II | |
| K011873 | Dornier Lithotripter S(doli S) & Dornier Lithotripter S-Xp (Doli S-Xp) | Dornier | LNS | Class II | |
| K011781 | Intercept-Urethral Microcoil | Surgi-Vision, Inc. | MOS | Class II | |
| K011725 | Olympus Suction Pump, Model Kv-5 | KEYMED (Medical & Industrial Equipment) Ltd | JCX | Class II | |
| K011543 | TENS Care, Model Xl-Y3 | Tenscare Ltd. | GZJ | Class II | |
| K011427 | Mbi Pd-103 Sl; Mbi Pd-103 Sh | Mills Biopharmaceuticals, Inc. | KXK | Class II | |
| K010204 | Stryker Navigation System-Knee Module | Stryker Corp. | HAW | Class II | |
| K012855 | Liquispx Liquid Lipid Control | Clinical Controls Division | JJY | Class I | |
| K012593 | Vitros Chemistry Products Magnetic Hdl-Cholesterol Reagent, Vitros Chemistry Products Calibrator Kit 2 | Ortho-Clinical Diagnostics, Inc. | LBR | Class I | |
| K012507 | The Trabecular Metal Technology Acetabular Augment System, Models 4893-Xx-Yy (Zimmer), 02-212-05Xx1 ( Implex) | Implex Corp. | LPH | Class II |