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 |
|---|---|---|---|---|---|
| K954711 | Stat Profile Ultra 11 Analyzer (Modification) | Nova Biomedical Corporation | CHL | Class II | |
| K954534 | Osteonics Unipolar Endo Head | Osteonics Corp. | KWL | Class II | |
| K954315 | PVC Abdominal/rectal Pressure Catheter | Life-Tech Intl., Inc. | FEN | Class II | |
| K954288 | Extend Hip System | Wrightmedicaltechnologyinc | LPH | Class II | |
| K953981 | Synthasil Aptt Reagent | Ortho Diagnostic Systems, Inc. | GFO | Class II | |
| K953908 | Davis & Geck Ligating Clip Remover | Davis & Geck, Inc. | FZP | Class II | |
| K953790 | Bd Perisafe Epidural Anesthesia Tray | BD Becton Dickinson Vacutainer Systems Preanalytic | CAZ | Class II | |
| K953651 | Diagnostic Electrophysiology Catheter System | Arrow Intl., Inc. | DRF | Class II | |
| K953404 | Osteo-Ray 100 | Micro-Focus Imaging., Inc. | IZL | Class II | |
| K953136 | Rs-4M | RS Medical | IPF | Class II | |
| K950602 | Port Caps (Protective Closures Foe Reprocessed Hemodialyzers | Reprocessing Products Corp | FJI | Class II | |
| K941992 | Cystoscope | Surgical Technologies, Inc. | FBO | Class II | |
| K955035 | Vidamed Series 7205 Electrosurgical Generator | Vidamed, Inc. | GEI | Class II | |
| K954813 | ICU Extension Kit | Abbott Medical | FPA | Class II | |
| K954810 | Myerson Ir Denture Base | Austenal, Inc. | EBI | Class II | |
| K954755 | Coat-a-Count Direct Androstenedione | Siemens Healthcare Diagnostics Inc. | CIZ | Class I | |
| K954726 | Stryker Strykeflow Suction Irrigator (Modification) | Stryker Corp. | GCX | Class II | |
| K954536 | Blade, Scalpel & Blade, Handel | Access Surgical Intl., Inc. | OCZ | Class II | |
| K954413 | Kelocote | Allied Biomedical Corp. | MDA | Class I | |
| K954382 | Prolastic Sheeting | Pillar Surgical, Inc. | MIB | Class II | |
| K954370 | Wheel Lemaster | Heliarc Specialists, Inc. | IOR | Class I | |
| K954287 | Aci Fine Needle Aspiration Biopsy Kit | Advanced Cytometrix, Inc. | BTA | Class II | |
| K954286 | Aci Pulsating Vacuum Pump System | Advanced Cytometrix, Inc. | BTA | Class II | |
| K954264 | Aci Single Lumen Biopsy Needle | Advanced Cytometrix, Inc. | BTA | Class II | |
| K954243 | Tecnol Saline Wet Dressing | Tecnol Medical Products, Inc. | FRO | Unclassified | |
| K954181 | Canyons Bi-Directional Check Valve | Canyon Medical Products | KYX | Class I | |
| K954073 | Stc Diagnostics Lsd Micro-Plate Eia | Solarcare Technologies Corp,Inc. | DLB | Class II | |
| K953961 | Osteonics Insight Knee Positioning & Alignment System | Osteonics Corp. | FWW | Class I | |
| K953885 | Spyroflex Skin Protector | Polymedica Industries, Inc. | MGP | Unclassified | |
| K953800 | Mlt 20 | Medical Laser Technology, Inc. | GEX | Class II | |
| K953793 | Introscope | Polamedco, Inc. | BZT | Class II | |
| K953689 | Wagner Revision Stem (Modification) | Intermedics Orthopedics | LZO | Class II | |
| K953688 | Cls Acetabular Component (Modification) | Intermedics Orthopedics | LZO | Class II | |
| K953352 | Proteam Cushion | Iskra.Med | KIC | Class I | |
| K953254 | Strato/infusaid Infuse-a-Kit | Strato/Infusaid, Inc. | LJT | Class II | |
| K952946 | Vangator II | Crow River Industries, Inc. | ING | Class II | |
| K952184 | Carbomedics Supra-Annular Valve Sizer | Carbomedics, Inc. | DTI | Class I | |
| K951760 | Optilite VIII Laser Surgery Accessories | Xintec Corporation | GEX | Class II | |
| K950969 | Disposable Syringe | Surgiplast, Ltd. | FMF | Class II | |
| K950826 | Am Ruby | American Lasers, Inc. | GEX | Class II | |
| K944767 | Dialysis Machine with Dialysate Ultrafilter | Fresenius USA, Inc. | FIP | Class II | |
| K944539 | Drs 4 Nd Dialyzer Reprocessing System | Seratronics, Inc. | LIF | Class II | |
| K940933 | 9267 Spo2 Athena Module | S & W Medico Teknik | DQA | Class II | |
| K930181 | Biopure Dialysate Concentrate Mix Syst/concentrate | Fresenius USA, Inc. | FKP | Class II | |
| K955024 | Liquichek Ethanol/ammonia Control | Bio-Rad | JJY | Class I | |
| K954592 | Vacutainer Brand Pst Plasma Separation Tube | Becton Dickinson Vacutainer Systems | JKA | Class II | |
| K954317 | Diag Fast-Cath Duo & Trio Removable Hemostasis Adapters W/sideports & 3-Way Stopcocks | Daig Corp. | DYB | Class II | |
| K953763 | Gladiator Antishock Pants | Jobst Institute, Inc. | LHX | Class II | |
| K952470 | Acti-Flex Low, Medium, Rescare I, Rescare II. | R-Group Intl. | GCD | Class I | |
| K954989 | Dyonics Disposable Endoscopic Surgery Blades | Smith & Nephew Dyonics, Inc. | ERL | Class II |