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 |
|---|---|---|---|---|---|
| K905410 | Opus T3 Test System | Pb Diagnostic Systems, Inc. | CDP | Class II | |
| K905280 | Biotrol Bilirubin C & T Control | Biotrol, USA, Inc. | JJX | Class I | |
| K905278 | Sts(tm) Fluoroscopic Imaging Module | Medstone Intl., Inc. | JAA | Class II | |
| K905146 | Olympus Urine Ph | Diagnostic Systems | JQY | Class I | |
| K905108 | Contorno(r), Models E and St | Palex Intl. SA | GEI | Class II | |
| K904990 | Emit Convenience Pack, Quinidine Assay/calibrators | Syva Co. | LBZ | Class II | |
| K903941 | Shimadzu Digital Subtraction System Dar-2400 | Shimadzu Medical Systems | IZI | Class II | |
| K903876 | Montgomery(r) Tapered Safe-T-Tube(tm) | Boston Medical Products, Inc. | BTR | Class II | |
| K903731 | Sapphire Series 1P, 1L, 2L, and 2Me | Teca, Inc. | GWF | Class II | |
| K903639 | Nidek Dc-3000 Diode Laser Photocoagulator | Nidek, Inc. | GEX | Class II | |
| K903469 | Gamma 600 Nuclear Medicine Computer | Strichman Medical Equipment, Inc. | IYX | Class I | |
| K910201 | Life O2 | Life Corp. | BTL | Class II | |
| K910171 | Maxi-Flow Suction Set W/y Connector | Adler Instrument Company | GAZ | Class II | |
| K910170 | Maxi-Flow Suction Set 12 Ft. | Adler Instrument Company | GAZ | Class II | |
| K905858 | Catalog No. 6000-21 Volume Neck Coil, Modification | Medical Advances, Inc. | LNH | Class II | |
| K905727 | Usci Satin Finish Soft Tip Angiographic Catheter | C.R. Bard Inc | DQO | Class II | |
| K905714 | Ercp Cannula | Everest Medical Corp. | FGE | Class II | |
| K905638 | Sarns Invent Catheters | 3M Health Care, Sarns | DWF | Class II | |
| K905615 | Magnetic Resonance Diag. Dev. Special Purpose Coil | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K905407 | Model 3487A Pisces-Quad,3587a Resume,3586 Resume | Medtronic, Inc. | GZB | Class II | |
| K905297 | Diaventional Catheter | Cordis US Corp. | DQO | Class II | |
| K905214 | Immulite (Tm) Total T3 | Cirrus Diagnostics, Inc. | CDP | Class II | |
| K905195 | Firm Master | Bak Medical Products | LKY | Class II | |
| K904690 | Temp Marq(tm) Convective Warming System | Marquest Medical Products, Inc. | DWJ | Class II | |
| K904575 | Model 5866-37M Lead Adaptor Kit | Medtronic, Inc. | DTD | Class II | |
| K904491 | Tmp Left Atrial Pressure Cath Cat.# 100-00X-000 | Lifestream Int'L, Inc. | DQO | Class II | |
| K904434 | Sexton Cystotomy Urine Pump (Scup2) | Phoenix Bioengineering, Inc. | KOB | Class II | |
| K904095 | Herpes Simplex Virus Tissue Culture Conf. Typing | California Integrated Diagnostics, Inc. | GQL | Class II | |
| K903571 | Micrel Ltd Portable Infusion Micropump | Technology Transfer Intl., Inc. | FRN | Class II | |
| K902999 | Vascular Retrieval Forceps | Cook Inc. | DQY | Class II | |
| K910029 | Patient Care Management System Modification | Spacelabs, Inc. | DXK | Class II | |
| K905812 | Intrauterine Catheter Set | Epcom Medical Systems, Inc. | HGS | Class II | |
| K905769 | Immulite Hs-Tsh | Cirrus Diagnostics, Inc. | JLW | Class II | |
| K905731 | Flexible Endoscopic Electrode | Applied Urology, Inc. | FAS | Class II | |
| K905661 | Systemate Total Protein (Epos Application) #65420 | Em Diagnostic Systems, Inc. | CEK | Class II | |
| K905651 | Kinetic Amylase Determination | Biochemical Trade, Inc. | JFJ | Class II | |
| K905473 | Ubi Magiwel Cortisol Quantitative | United Biotech | CGR | Class II | |
| K905440 | Fine Size Nonabsorbable Dacron Surgical Suture | United States Surgical, A Division of Tyco Healthc | GAS | Class II | |
| K905417 | Elmed Pneumomat Digital | Elmed, Inc. | HIF | Class II | |
| K905391 | Ust-969-5 Convex Transducer | GE Medical Systems Information Technologies, Inc. | ITX | Class II | |
| K905268 | Flowers Jowl Implant | Implantech Associates Inc | FWP | Class II | |
| K905267 | Flowers Chin Implant | Implantech Associates Inc | FWP | Class II | |
| K905106 | Auto Suture(r) Ta Premium(tm) Urology Stapler | United States Surgical, A Division of Tyco Healthc | GDW | Class II | |
| K905105 | Jain Suture/vesiband Organizer | Jain Surgical Equipment, Inc. | MDM | Class I | |
| K905082 | Pegasus with Accessories | Pfizer Laser Systems | GEX | Class II | |
| K905080 | Med-West Dual Lumen Internal Jugular Catheter | Kendall Healthcare Products Co. Div.Of Tyco Health | LFJ | Class II | |
| K905069 | Iodosorb Gel | Perstorp AB C/O Robert Joel Slomoff | KOZ | Class I | |
| K905011 | Oral Pharyngeal Cleansing Device | Concord/Portex | EIA | Class I | |
| K905000 | Aloka Ust-964P-5 Endovaginal Transducer | Corometrics Medical Systems, Inc. | HEM | Class II | |
| K904972 | Surgicare Sterile Surgical Gloves | Kanam Latex Industries Pvt. Ltd. | KGO | Class I |