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 |
|---|---|---|---|---|---|
| K042565 | Encompass Hip Stem, Tri-Plus Acetabular Shell, Tri-Plus Dcm Liner | Ortho Development Corp. | LPH | Class II | |
| K050771 | Lupine Loop | DePuy Mitek, Inc. | GAM | Class II | |
| K050765 | Lano-E Powder-Free Nitrile Examination Glove | N.S. Uni-Gloves Sdn. Bhd. | LZA | Class I | |
| K050704 | Modification to: Revolution Xr/d Digital Radiographic Imaging System with Image Pasting and Autopositioning | General Electric Co. | KPR | Class II | |
| K050692 | Flxis | Philips North America LLC | JAA | Class II | |
| K050663 | Traxyloc-1 System | Traxyz Medical, Inc. | IZH | Class II | |
| K050622 | Hrw-63-8 Wrist Array Coil; Hrw-127-8 Wrist Array Coil | Mri Devices Corp. | MOS | Class II | |
| K050244 | Male Natural Rubber Latex Condom | Nrs Global Partners | HIS | Class II | |
| K050083 | Blood-Pressure Meter, Bpw120 | Idt Technology Limited | DXN | Class II | |
| K043543 | Blood Glucose Monitoring System | American Healthcare Corp. | NBW | Class II | |
| K043529 | Accu-Chek Advisor Insulin Guidance Software | Roche Diagnostics GmbH | NDC | Class II | |
| K043512 | Easygluco Igm-0002 G2 | American Healthcare Corp. | CGA | Class II | |
| K043443 | One Step Hcg Urine Pregnancy Test | Guangzhou Wondfo Biotech Co., Ltd. | LCX | Class II | |
| K043253 | Vanguard Reprocessed Dilating Tip and Blunt Trocars | Stryker Sustainability Solutions | NLM | Class II | |
| K042958 | Durex Play Tingling Lubricant | Ssl Americas, Inc. | NUC | Class II | |
| K041515 | Truglyde Absorbable Polyglycolic Acid Surgical Suture | Sutures India Private Limited | GAM | Class II | |
| K050714 | Full Automatic (Nibp) Blood Pressure Monitor, Models Hl168ga, Hl168gs | Health & Life Corporation | DXN | Class II | |
| K050711 | Full Automatic (Nibp) Blood Pressure Monitor, Model Hl168jt | Health & Life Corporation | DXN | Class II | |
| K050664 | Spor-Test Pa Biological Indicator Kit | Getinge USA, Inc. | FRC | Class II | |
| K050641 | Zygoma Tiunite | Nobel Biocare USA LLC | NHA | Class II | |
| K050628 | Anspach Coupler | The Anspach Effort, Inc. | HBE | Class II | |
| K050621 | Nva-127-8-a Neurovascular Array Coil | Mri Devices Corp. | MOS | Class II | |
| K050602 | Altaire | FUJIFILM Healthcare Americas Corporation | LNH | Class II | |
| K050598 | Powder Free Nitrile Examination Glove with Tested for Use with Chemotherapy Drugs Labeling Claim (Blue) | Smart Glove Corp. Sdn Bhd | LZA | Class I | |
| K050485 | 20.8-Inch(53cm) Monochrome Lcd Monitor Mdl2110a (Me351i), (Dv3mm-Hb) | Totoku Electric Co., Ltd. | LLZ | Class II | |
| K050408 | Bicon Orthodontic Implant System | Bicon, LLC | DZE | Class II | |
| K050377 | Nbd Head Screw | New Business Development, LLC | HAW | Class II | |
| K050376 | Prowin | Medical Technologies International, Inc. | LLZ | Class II | |
| K050225 | Heartwave II Cardiac Diagnostic System | Cambridge Heart, Inc. | DQK | Class II | |
| K050207 | Bd Posiflow Positive Displacement Valve | Becton Dickinson Infusion Therapy Systems Inc. | FPA | Class II | |
| K042710 | Surgitron Radiolase II | Ellman Intl., Inc. | GEI | Class II | |
| K042411 | Abbott Imx Sirolimus Microparticle Enzyme Immunoassay | Axis-Shield, Ltd. | NRP | Class II | |
| K042007 | Zoll E Series Defibrillator | ZOLL Medical Corporation | MKJ | Class III | |
| K050755 | Modification to Bvblue | Gryphus Diagnostics, L.L.C. | MXB | Class I | |
| K050750 | Lc Bracket Adhesive System | Dentsply Intl. | DYH | Class II | |
| K050740 | Microware 200 | Microware, Inc. | GZJ | Class II | |
| K050688 | Tegress Implant Needle | C.R. Bard Inc | FBK | Class II | |
| K050652 | Spotchem II Creatinine, Amylase & Alp Tests | Arkray, Inc. | CGX | Class II | |
| K050611 | Endotine Ribbon | Coapt Systems, Inc. | GAM | Class II | |
| K050606 | Synthes 1.0Mm Ti. Cortex, Self-Drilling Screws (Carniofacial) | Synthes (USA) Products LLC | DZL | Class II | |
| K043539 | Demetech Sterile Synthetic Absorbable Sutures (Pga) and Needles | Demetech Corp. | GAM | Class II | |
| K050742 | M3290a Intellivue Information Center Software Release G.00 | Philips North America LLC | MHX | Class II | |
| K050648 | Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack | Advanced Medical Optics, Inc. | HQC | Class II | |
| K050614 | Muse Cardiology Information System | GE Medical Systems Information Technologies, Inc. | DQK | Class II | |
| K050587 | Full Automatic (Nibp) Blood Pressure Monitor, Models Hl888km, Hl888dm | Health & Life Corporation | DXN | Class II | |
| K050567 | Health Buddy Appliance | Health Hero Network, Inc. | DRG | Class II | |
| K050515 | Bone Block Fixation Set | Straumann USA, LLC | DZL | Class II | |
| K050505 | Depotone | Imprint Pharmaceuticals Limited | FMI | Class II | |
| K050169 | Hl 200 Electronic Stethoscope | Health & Life Corporation | DQD | Class II | |
| K050134 | Icc Insulin Safepro Safety Syringe | Formosa Medical Devices, Inc. | MEG | Class II |