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 |
|---|---|---|---|---|---|
| K912453 | Intelijet Tm Fluid Management System | Smith & Nephew Dyonics, Inc. | HRX | Class II | |
| K912341 | Multicam I 8X10 | Camtronics, Ltd. | JAA | Class II | |
| K912290 | Healy/montgomery Stent System (Hms System(tm)) | Boston Medical Products, Inc. | BTR | Class II | |
| K912053 | Open Heart Tray | Medical Device Inspection Company | FSM | Class I | |
| K911932 | J105 James Surgical System I/a Pack | O.R. Specialties, Inc. | GZX | Class I | |
| K911841 | Minxray P300 X-Ray System | Minxray Inc | IZL | Class II | |
| K911809 | New-Vent | Concord/Portex | JKA | Class II | |
| K911772 | Gardner Pins (Adult & Child) | Cerenovus, Inc. | HBL | Class II | |
| K911427 | Breathing Filters | Intersurgical Ltd. | CAH | Class II | |
| K911340 | Autocomp | Victoreen, Inc. | KPQ | Class II | |
| K911322 | Model #M9 Ultraclave Steam Sterilizer | Midmark Corp | FLE | Class II | |
| K911207 | Oxicomplus | Waters Instruments, Inc. | DQA | Class II | |
| K910982 | Innervision Irrigation Pump | M.D. Engineering, Inc. | HEI | Class II | |
| K910968 | P.f.c. Unicondylar Knee System | Johnson & Johnson Orthopaedics, Inc. | HRY | Class II | |
| K910921 | Auto Suture Surgiport Tissue Grip Disposable Sleev | United States Surgical, A Division of Tyco Healthc | HET | Class II | |
| K910789 | Kavoklave Steam Autoclave | Kavo America | FLE | Class II | |
| K913594 | Dynex Iiib, Model 89002026 | Medtronic, Inc. | GZJ | Class II | |
| K913329 | V-Acci-Guard(tm) Reusable Holder | Medical Safety Products, Inc. | FMI | Class II | |
| K913043 | Modification Tecnol Fluidshield Surgical Masks | Tecnol New Jersey Wound Care, Inc. | FXX | Class II | |
| K912918 | Iris Oculight Diode Laser Adding Slit Lamp Adapter | Iriderm Div. | GEX | Class II | |
| K912788 | Curay Support | Scientific Pharmaceuticals, Inc. | EBF | Class II | |
| K912540 | Contour-Port | Ideal Medical, Inc. | LJT | Class II | |
| K912480 | Bbl(r) Dmaca Indole Reagent Droppers | BD Becton Dickinson Vacutainer Systems Preanalytic | JTO | Class I | |
| K910193 | Huene Fixation Screw | Acu Med, Inc. | HWC | Class II | |
| K913272 | Ems/400 | Altoona Medical Supply | IPF | Class II | |
| K913134 | Model 4220 | Pace Medical | DXY | Class III | |
| K912914 | Danby-Dcr Volumetric Infusion Pump | Danby Medical, Ltd. | FRN | Class II | |
| K912846 | Justone(tm) | Sensititre Microbiology A Div. of Radiometer | JWY | Class II | |
| K912832 | Bacti-Swab(tm) Npg | Remel Inc | LIO | Class I | |
| K912774 | Arachidonic Acid | Helena Laboratories, Corp. | JBX | Class II | |
| K912613 | Gentamicin 500 Ug/ml to Be Included in Justone(tm) | Sensititre Microbiology A Div. of Radiometer | JWY | Class II | |
| K912320 | Biophysiometer Positioning Chair | Bi-Dynamics, Inc. | INO | Class II | |
| K912319 | Davis & Geck Chromic & Plain Gut Ligature Carrier | Davis & Geck, Inc. | GCJ | Class II | |
| K912317 | Schneider Monorail 421 Percu Trans Angio Pta Cath | Schneider Intl., Ltd. | LIT | Class II | |
| K912240 | CPAP System and Broncho-Cath W/cpap System | Mallinckrodt Anesthesia Products | BYE | Class II | |
| K912034 | Veneto Collection | Atlantic Optical Co., Inc. | HQZ | Class I | |
| K912025 | Spectrolyse Plasminogen Sk Kit | Biopool AB | GGP | Class II | |
| K911777 | Rocket Reference Plasma, Cat. No. 5188, Modified | Helena Laboratories, Corp. | GGN | Class II | |
| K911351 | Biochem 9100 Multigas Monitor Temp/fio1 Mod,nibp | Biochem International, Inc. | DXN | Class II | |
| K911051 | Monarch System | Baxter Healthcare Corporation | MHX | Class II | |
| K910785 | Titanium Catheter Extender | Accurate Surgical Instruments Co. | FJS | Class II | |
| K910381 | Biochem Temperature/ Fio2 Module | Biochem International, Inc. | CCL | Class II | |
| K900343 | Gap-Igg | Biomerica | LYR | Class I | |
| K913400 | Model Scr-1000 | Accucore, Inc. | DXH | Class II | |
| K912820 | Polyester Resin Hand Molded Tray | E&D Dental Products, Inc. | EBH | Class I | |
| K912661 | Matrx, Pyramid Triangle Bandage | Matrix Medica, Inc. | ILI | Class I | |
| K912608 | Star*shades(tm) Sunglasses | Nalpac, Ltd. | HQY | Class I | |
| K912426 | Uhmwp Acetabular Component | Howmedica Corp. | JDI | Class II | |
| K912332 | Microsurge Laser Fiber Holder | Microsurge, Inc. | GEX | Class II | |
| K911936 | Osteomed Sbf System (Sbf) | Osteomed | DZL | Class II |