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 |
|---|---|---|---|---|---|
| K960600 | Lexur Enamel Coating-Porcelain Repair-Bonding Veneers | Dent Zar, Inc. | EBF | Class II | |
| K960599 | Superior Photocuring Hybrid Composite | Dent Zar, Inc. | EBF | Class II | |
| K960598 | Concord Maryland Bridge Cement | Dent Zar, Inc. | EBF | Class II | |
| K960597 | Orion-1 Vl Crown Base and Post Cement Visible Light Cure | Dent Zar, Inc. | EBF | Class II | |
| K960596 | Orion-I Core Build-Up Material Chemical Cure | Dent Zar, Inc. | EBF | Class II | |
| K960595 | Fantastic 1 Contact Cure Orthodontic Adhesive for Plastic and Metal Brackets | Dent Zar, Inc. | EBF | Class II | |
| K960594 | Light Super Bond-1 Light Cured Orthodontic Adhesive for Metal, Plastic and Ceramic Brackets | Dent Zar, Inc. | EBF | Class II | |
| K960585 | Wound Care Compression System (Wccs) | Suncoast Medical Products, Inc. | MCY | Class II | |
| K960572 | Therex Low Profile B Port 1.0Mm I.d./1.8mm O.d. Detached Catheter | Arrow Intl., Inc. | LJT | Class II | |
| K960562 | Gleeson Flo Vac & Selectone S/i Cannulae Model 60-6001, 6002, 6005 | Conmedcorp | GCJ | Class II | |
| K960561 | Dsl Active Prolactin Elisa Model 10-4500 | Diagnostic Systems Laboratories, Inc. | CFT | Class I | |
| K960548 | Ah Plus Root Canal Sealer | Dentsply Intl. | KIF | Class II | |
| K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | GEX | Class II | |
| K960488 | Neo 2 Line Suction System | Alcove Medical, Inc. | BSY | Class I | |
| K960475 | Modified Luxar Lx-20 Family CO2 Laser System | Luxar Corp. | GEX | Class II | |
| K960468 | Dmr/co2 Combo Kti | Medtronic, Inc. | BTM | Class II | |
| K960416 | Comfit Microptic | Wembley Rubber Products (M) Sdn Bhd | KGO | Class I | |
| K960415 | Wilson-Cook Balloon Inflation Device | Wilson-Cook Medical Inc. | KNT | Class II | |
| K960407 | Comfit Orthopedic | Wembley Rubber Products (M) Sdn Bhd | KGO | Class I | |
| K960397 | Medicator Aerosol Drug Delivery System | Healthline Medical | CAF | Class II | |
| K960395 | Plancon Mircolamellar Keratome | Plancon Instruments | HNO | Class I | |
| K960372 | Scanlan Heifetz Aneurysm Elgiloy Clip System | Scanlan Intl., Inc. | HCH | Class II | |
| K960279 | Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/constrained Condylar Knee Femoral Components/articular Surfaces | Zimmer GmbH | JWH | Class II | |
| K960103 | Dade Moni-Trol Candidate Product Combinations | Dade Intl., Inc. | JIX | Class II | |
| K955889 | Powderfree Latex Examination Gloves | Pantai Utama Sdn. Bhd. | LYY | Class I | |
| K955888 | Prepowdered Latex Examination Gloves | Pantai Utama Sdn. Bhd. | LYY | Class I | |
| K955355 | Variant Alpha-Thalassemia Short Program | Bio-Rad | GKA | Class II | |
| K955341 | Nil Latex Powderfree Examination Gloves | Shangrila Latex Industries Pvt., Ltd. | LYY | Class I | |
| K953443 | Consensus Pcl Subsituting Tibial Insert | U.S. Medical Products, Inc. | JWH | Class II | |
| K942844 | Level 1 Blood Stream Recovery System | Level 1 Technologies, Inc. | CAC | Class II | |
| K961249 | Accusign Met/biosign Met | Princeton BioMeditech Corp. | LAF | Class II | |
| K961211 | Argelite 52+ | Argen Precious Metals, Inc. | EJT | Class II | |
| K961123 | Alt Incorporating Dst | Trace Scientific, Ltd. | CKA | Class I | |
| K960992 | Bionike A/q Pregnancy Test | Bionike Laboratories, Inc. | JHI | Class II | |
| K960706 | Vascutek Vascusoft Plus Vascular Graft | Carbomedics, Inc. | DSY | Class II | |
| K960620 | Pressureguard: Low Air Loss Mattress System | Span-America Medical Systems, Inc. | FNM | Class II | |
| K960379 | Rotablator System's Guide Wire Line: Support Rotawire Rail Rota Wire | Heart Technology Mfg., Inc. | MCW | Class II | |
| K960275 | Opus Ck-Mb & Total Ck Controls | Behring Diagnostics, Inc. | JJT | Class I | |
| K955557 | Fluid Reisistant Eyeshield Mask | American Threshold Healthcare | FXX | Class II | |
| K955556 | Fluid Resistant Mask | American Threshold Healthcare | FXX | Class II | |
| K955464 | Tactylon Powder Free Examination Glove | Tactyl Technologies, Inc. | LZA | Class I | |
| K955013 | Nova Co-Oximeter Analyzer | Nova Biomedical Corporation | GLY | Class II | |
| K954976 | Potassium Nitrate Zinc Oxide Eugenol Temp Cement (Modification) | Healex Products, Inc. | EBG | Class II | |
| K954800 | Apr Hip Sys W/cal-Coated Can Str Titanium (Csti) | Intermedics Orthopedics | MEH | Class II | |
| K954486 | Mercury Airway Pressure Manometer | Mercury Medical | CAP | Class II | |
| K954401 | Gastrotec | Patrick C. Jacobssen | ESI | Class III | |
| K961268 | Oakley, Inc Sunglasses | Oakley, Inc. | HQY | Class I | |
| K961128 | Sunglasses | Vision-Pro Industrial, Ltd. | HQY | Class I | |
| K961117 | Visard Sunglasses | Visard SRL | HQY | Class I | |
| K961034 | Sunglasses | Kylie Enterprise Co., Ltd. | HQY | Class I |