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 |
|---|---|---|---|---|---|
| K903037 | Lupo-Test Reagent | Gradipore, Ltd. | GIR | Class I | |
| K902969 | Screw-Vent Endosseous Ha Coated Dental Implants | Core-Vent Corp. | DZE | Class II | |
| K902948 | Comfortron II (TENS) | M. D. Products | LWM | Unclassified | |
| K902631 | Cobe ICU Conversion Kit | Cobe Laboratories, Inc. | DTN | Class II | |
| K902437 | Cobe Cardiotomy Reservoir with or without Filter | Cobe Laboratories, Inc. | DTP | Class II | |
| K902404 | Sarns Delphin Centrifugal System W/direction. Flow | 3M Company | KFM | Class II | |
| K900814 | Cath Lab Automated Interactive Recorder Systems | Intellimetrics Instrument Corp. | DQK | Class II | |
| K900731 | Medi Liss Dental Analgesia Device (Sbl601) | Medical Consultants Intl., Ltd. | LWM | Unclassified | |
| K892671 | Wilson Biomedical Angiographic Catheter | Wilson Biomedical, Inc. | DQO | Class II | |
| K905441 | Mrt 35-a (Tm) | Toshiba America Mri, Inc. | LNH | Class II | |
| K904648 | Safe Syte i.v. Catheter Placement Unit | Deseret Medical, Inc. | FOZ | Class II | |
| K904486 | Support Pump | Numedtec, Inc. | LKY | Class II | |
| K904485 | Support Ring | Numedtec, Inc. | LKY | Class II | |
| K904473 | Kronner Manipujector | Unimar, Inc. | HES | Class II | |
| K904248 | Model Glase 210 Holmium Laser System | Charles L. Rose and Co., Inc. | HGF | Class II | |
| K904107 | Cap-Aid | Nda Systems | FMI | Class II | |
| K903614 | Harvard/lte Laboratory Steam Sterilizer Autoclave | Harvard Apparatus, Inc. | FLE | Class II | |
| K902858 | Avi Model 4206 Manifold Checkvalve IV Admin. Set | 3M Avi, Inc. | FPA | Class II | |
| K900509 | Norta Silicone Elastomer Coated Latex Balloon Cath | Medical Latex Corp. | KOD | Class II | |
| K895713 | 3M Igg Fastlyme(tm) Test | 3M Company | LSR | Class II | |
| K905386 | Distat Anti-Dsdna Kit | Shield Diagnostics, Ltd. | KTL | Class II | |
| K905380 | 1-Cut Acl Graft Knife | Depuy, Inc. | GDX | Class I | |
| K905202 | Turbiquant Myoglobin | Behring Diagnostics, Inc. | DDR | Class II | |
| K905194 | Diastat Anti-Ro (Ss-a) | Shield Diagnostics, Ltd. | LKO | Class II | |
| K905193 | Diastat Anti-La (Ss-B) | Shield Diagnostics, Ltd. | LKO | Class II | |
| K905176 | Positive Control Pad Allergen/food Allergen Screen | Ortho-Clinical Diagnostics, Inc. | DHB | Class II | |
| K904960 | Qualtex Surgical Drape | DeRoyal Industries, Inc. | KKX | Class II | |
| K904866 | Coulter Ck-Mb Isoenzyme Reagent | Coulter Electronics, Inc. | JHT | Class II | |
| K904856 | Abuscreen Ontrak for Thc | Roche Diagnostic Systems, Inc. | LDJ | Class II | |
| K904758 | Cardiofax ECG-8830A | Nihon Kohden America Inc | DPS | Class II | |
| K904721 | Dsl Ck-Mb (Dsl #3200) | Diagnostic Systems Laboratories, Inc. | JHT | Class II | |
| K904559 | Qualtex Skin Marker | Qualtex, Inc. | FZZ | Class I | |
| K904513 | Abl510 Blood Gas System | Radiometer America, Inc | CHL | Class II | |
| K904506 | Active Adapter | Beacon Laboratories, Inc. | GEI | Class II | |
| K904444 | Models 4000,4900,6000,8000,8900, Luxus 6&100/1700 | Heraeus Lasersonics, Inc. | GEX | Class II | |
| K904423 | CO2 Lasers and Infraguide Delivery System | Heraeus Lasersonics, Inc. | GEX | Class II | |
| K904262 | Minnow Penile Implant Protector | Ruja-Med Medical Marketing | FAE | Class II | |
| K904167 | Pathodx Herpes Typing | Siemens Healthcare Diagnostics Inc. | GQL | Class II | |
| K904147 | Hugh Young II Urological X-Ray System | Mallinckrodt Group, Inc. | KPR | Class II | |
| K904146 | Neuro Vision Radiographic X-Ray System | Mallinckrodt Group, Inc. | KPR | Class II | |
| K904145 | Hydra Vision Urological X-Ray System | Mallinckrodt Group, Inc. | KPR | Class II | |
| K904144 | Pulmovision Chest Radiography X-Ray System | Mallinckrodt Group, Inc. | IZP | Class II | |
| K903995 | Naphthol as-D Chlor/a-Naphthyl Acet Esterase Kit | Sigma Chemical Co. | GHD | Class I | |
| K903777 | Wrp Foleycath | Wembley Rubber Products (M) Sdn Bhd | EZL | Class II | |
| K903519 | Intertech(tm) Heat and Moisture Exchanger | Intertech Resources, Inc. | BYD | Class I | |
| K903470 | Qualture | Future Medical Technologies Intl., Inc. | JXA | Class I | |
| K903347 | Sodium Chloride Solution | Superior Healthcare Group, Inc. | FOZ | Class II | |
| K902723 | Arterial Blood Filter Electro. Air* Star 40 and 20 | Electromedics, Inc. | DTM | Class II | |
| K902377 | Angeflator(tm) | Angeion Corp. | DXT | Class II | |
| K901605 | Phoenix Laser Systems Ophthalmic Surgical Worksta. | Phoenix Laser Systems, Inc. | LXS | Class II |