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 |
|---|---|---|---|---|---|
| K060492 | Aesculap Craniofacial Plate and Screw | Aesculap Inc | JEY | Class II | |
| K060366 | The Amo Ophthalmic Surgical System | Advanced Medical Optics, Inc. | HQC | Class II | |
| K060330 | See-It Caries Detector | Ronvig Dental Mfg. a/S | LFC | Class II | |
| K060315 | Healthstats Bpro Ambulatory Blood Pressure Monitoring System | Healthstats International Pte., Ltd. | DXN | Class II | |
| K060245 | Harmonic Scalpel Blades and Shears | Ethicon Endo-Surgery Inc | LFL | Unclassified | |
| K060114 | Vectra Laser System | Xintec Corporation, dba | GEX | Class II | |
| K060105 | Vpap III St-A/kidsta Mask System | ResMed Corp | MNS | Class II | |
| K053628 | Lightsheer Duet Laser System | Lumenis Ltd | GEX | Class II | |
| K053563 | Humapen Memoir | Eli Lilly and Company, Pharmaceutical Delivery Systems | FMF | Class II | |
| K051798 | Osteomed Orthodontic Anchor Plating System | Osteomed | DZE | Class II | |
| K051227 | Renu Medical Reprocessed Alp 1 Calf Garment, Model Alp1 | Renu Medical, Inc. | JOW | Class II | |
| K060780 | Tonometer Diaton | Ryazan State Instruments | HKX | Class II | |
| K060714 | Hi-Fi Ultrafix Knotless Minimite Suture Anchor | Conmed Linvatec | HWC | Class II | |
| K060650 | Vitros Chemistry Products D%a1c Reagent Kit, Model 680 2314; Vitros Chemistry Products Calibrator Kit 18, Model 680 1702 | Ortho-Clinical Diagnostics, Inc. | LCP | Class II | |
| K060638 | Dynesys Spinal System with Ha Coated Screws | Zimmer Spine, Inc. | NQP | Class II | |
| K060628 | Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/dbi Calibrator | Siemens Healthcare Diagnostics Inc. | CIG | Class II | |
| K060548 | Stratus Cs Acute Care Betahcg and Nt-Probnp Testpak and Testpak Assay, Calpak and Dilpak | Siemens Healthcare Diagnostics Inc. | DHA | Class II | |
| K060385 | Emit 2000 Tacrolimus Assay and Sample Pretreatment Reagent | Siemens Healthcare Diagnostics Inc. | MLM | Class II | |
| K060314 | Rotating Gamma System. Gamma Art-6000 | American Radiosurgery, Inc. | IWB | Class II | |
| K060309 | Autocat Intra-Aortic Balloon Pump Series | Arrow Intl., Inc. | DSP | Class II | |
| K060044 | Acute Care Face Mask, Model Rt040 | Fisher & Paykel Healthcare, Inc. | MNT | Class II | |
| K053413 | Terumo Syringe for Administration of UV Sensitive Medicines | Terumo Europe N.V. | FMF | Class II | |
| K052420 | G-Spec Articulated Weighted Vaginal Speculum | Gynova, LLC | HIB | Class II | |
| K051927 | Techlab Asca-Chek | Techlab, Inc. | NBT | Class II | |
| K050989 | Awq-104 | Lhasa Oms, Inc. | GZJ | Class II | |
| K050988 | Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls | Lin-Zhi International Inc | DLG | Class I | |
| K060779 | Advance Vessel Analysis II | GE Healthcare | JAK | Class II | |
| K060741 | Swirlgraft Vascular Access Graft | Veryan Medical Limited | DSY | Class II | |
| K060617 | Pts Panels Hdl Cholesterol Test Strips | Polymer Technology Systems | NAQ | Class I | |
| K060566 | Minxray, Models Hfp24 and Hfp40 | Mikasa X-Ray Co., Ltd. | IZL | Class II | |
| K060357 | Trek S Nebulizer Compressor | Pari Innovative Manufacturers, Inc. | CAF | Class II | |
| K060326 | Lasertx - Diode Laser & Delivery System | Prosurg, Inc | GEX | Class II | |
| K053478 | Endosseous Dental Implant System | Northern Implants, LLC | DZE | Class II | |
| K053407 | Oxygen Analyzer, Models Aii 20000A, Aii 2000Hc, Aii 2000M | Analytical Industries, Inc. | CCL | Class II | |
| K053121 | Tram Module | GE Healthcare | MHX | Class II | |
| K052564 | Vygon Leader-Flex | Vygon Corp. | FOZ | Class II | |
| K060749 | Xperct | Philips North America LLC | IZI | Class II | |
| K060703 | Pmp4 Bp Pro Blood Pressure Monitor | Card Guard Scientific Survival, Ltd. | DXN | Class II | |
| K060655 | Scoutpro 8F, Models 342 262; Hemostatic Valve, Models 345 968; Hook Guiding Catheter, Models 342 263; Multi-Purpose H | BIOTRONIK AG | DQY | Class II | |
| K060432 | Novabone Porous-Bone Graft Scaffold | Novabone Products, LLC | MQV | Class II | |
| K060342 | Rossmax Automatic Blood Pressure Monitor Model Mo701k | Rossmax International Ltd. | DXN | Class II | |
| K060254 | Modification to Infinity Explorer | Draeger Medical Systems, Inc. | MSX | Class II | |
| K060190 | Super Sheath Xl Introducer Sheath | Togo Medikit Co., Ltd. | DYB | Class II | |
| K053388 | Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option | Medtronic, Inc. | CBK | Class II | |
| K052319 | Impedimed - Body Composition Analyzer, Model Imp Sfb7 | Impedimed, Inc. | MNW | Class II | |
| K051438 | Vanguard Reprocessed Compression Garments (Hill-Rom) | Alliance Medical Corp. | JOW | Class II | |
| K050913 | Dick's Formalwear Male Latex Condom | Dick'S Formalwear, Inc. | HIS | Class II | |
| K060014 | Intelifuse, Inc., Warmsystem with Stimulinks | Intelifuse, Inc. | JDR | Class II | |
| K053543 | Arthrex Arthoeresis Implant | Arthrex GmbH | HWC | Class II | |
| K052118 | Dose Verification System | Sicel Technologies, Inc. | LHN | Class II |