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 |
|---|---|---|---|---|---|
| K071735 | Modification to Disposable Infusion Pump Kit | Symbios Medical Products, LLC | MEB | Class II | |
| K071676 | Exactech Novation Crown Cup Constrained Liners and Rings | Exactech, Inc. | KWZ | Class II | |
| K071292 | View Md Office System, Model 41066.5540 | Richard Wolf Medical Instruments Corp. | GCJ | Class II | |
| K071288 | Modification to Kavo Quattrocare | Sybron Dental Specialties, Inc. | EBF | Class II | |
| K070465 | Busse Epidural Catheter | Busse Hospital Disposables | BSO | Class II | |
| K071882 | Model Cg-Whc18-H150-Ap - Wrist Hand Coil 1.5T 4 Ch, | Shanghai Chenguang Medical Technologies Co, Ltd | MOS | Class II | |
| K071715 | Acumed Congruent Bone Plate System | Acumed LLC | HRS | Class II | |
| K071673 | Onc Solutions Marker, Models 001001 to 001012 and 001021 to 001032 | Onc Solutions, Inc. | IYE | Class II | |
| K071665 | Scoutpro Slitter Tool Advanced, Model 356 552 | BIOTRONIK AG | DQY | Class II | |
| K071556 | Somnoscreen Eeg10-20 | Somnomedics AG | MNR | Class II | |
| K071550 | Pre-Waxed Needles with Gold Fiduciary Markers | Cp Medical | KXK | Class II | |
| K071423 | Medline Latex Foley Catheter | MEDLINE INDUSTRIES, LP - Northfield | EZL | Class II | |
| K071381 | Gammamedplus IX Series Hdr Afterloader | Varian Medical Systems, Inc. | JAQ | Class II | |
| K071163 | Weinmanncomfort 2, Model Wm 27600 and Weinmannaqua, Model Wm 27603 | Weinmann Gerate Fur Medizin GmbH + Co. KG | BZD | Class II | |
| K070608 | Smartep, Model M010000 | Intelligent Hearing Systems Corp. | GWJ | Class II | |
| K070346 | Dade Behring Labpro Alert Software System | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K061495 | Vr Lung Electrosonograph | Deep Breeze, Ltd. | OCR | Class II | |
| K071260 | Hermes Bond 3 | 3M Espe AG Dental Products | KLE | Class II | |
| K071175 | Ohmeda Medical Giraffe Omnibed | GE Healthcare | FMZ | Class II | |
| K071111 | Non-Absorbable Silk Suture | Arrow Intl., Inc. | GAP | Class II | |
| K070461 | Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4 | STERIS Corporation | JOJ | Class II | |
| K070435 | Dr Brown's Natural Flow Double Electric Breast Pump, Model# 1400 | Whittlestone, Inc. | HGX | Class II | |
| K070428 | Medicom Self-Sealing Sterilization Pouch | A.R. Medicom, Inc. | KCT | Class II | |
| K061934 | Xtac | Osteogenics, Inc. | FTL | Class II | |
| K071494 | Capiox Fx15 and Fx25 Hollow Fiber Oxygenator and Arterial Filter | Terumo Corp. | DTZ | Class II | |
| K071467 | Varisource IX Hdr Afterloader | Varian Medical Systems, Inc. | JAQ | Class II | |
| K070936 | Welmed Hypodermic Syringe | Welmed, Inc. | FMF | Class II | |
| K070500 | Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 Slim | Ni Medical | DSB | Class II | |
| K070299 | Ezfit Digital Heating TENS (Model No.: Hr-661/Uc-101) | Ezfit Technology, Inc. | GZJ | Class II | |
| K063710 | Saturn 9000 | New Medical Co., Ltd. | MQB | Class II | |
| K071728 | Modification to: Enseal Ptc Tissue Sealing Device | Surgrx, Inc. | GEI | Class II | |
| K071721 | Asahi Astato 30 Peripheral Guide Wire, Models - Pagh18m071, Pagh18m371 | Asahi Intecc Co., Ltd. | DQX | Class II | |
| K071718 | Trilogy Longevity Constrained Liner | Zimmer GmbH | KWZ | Class II | |
| K071664 | Trellis-6 Peripheral Infusion System | Bacchus Vascular, Inc. | QEY | Class II | |
| K071354 | Mepilex Ag Dressing | Monlycke Health Care | FRO | Unclassified | |
| K071322 | Powder Free Latex Examination Gloves | Quality Gallant Sdn. Bhd. | LYY | Class I | |
| K071309 | Blue Max Balloon Dilatation Catheter | Boston Scientific Corporation | LIT | Class II | |
| K070852 | Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color | Shijiazhang Hongxiang Plastic Products Co., Ltd. | LYZ | Class I | |
| K070746 | Restraxx Data Centre, Model R10 | ResMed Corp | BZD | Class II | |
| K070709 | Roche Elecsys Pth Test System | Roche Diagnostics GmbH | CEW | Class II | |
| K070704 | Trilogy Analyzer | Drew Scientific, Ltd. | CGA | Class II | |
| K070636 | Autovent 4000 with CPAP | Allied Medical LLC | BTL | Class II | |
| K070631 | Device Modification to Radius Spinal System | Howmedica Osteonics Corp | NKB | Class II | |
| K070599 | Customized Sound Therapy (Cst) | Tinnitus Otosound Products, LLC | KLW | Class II | |
| K070581 | Silver Alginate II Wound Dressing | Advanced Medical Solutions Limited | FRO | Unclassified | |
| K070577 | On the Go Sharps | Medport, Inc. | MMK | Class II | |
| K070555 | Orthopro Steinman Pins and Kirschner Wires | Orthopro, LLC | HTY | Class II | |
| K070392 | Mosaic Laser System | Lutronic Corporation | GEX | Class II | |
| K070183 | Kronus Insulin Autoantibody (Iaa) Assay Kit | Kronus Market Development Associates, Inc. | OCN | Class II | |
| K070132 | Tripore, Models Ha, Bp90, Bp15 | Orthogem Limited | MQV | Class II |