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 |
|---|---|---|---|---|---|
| K961234 | Depuy Advantage Fixation Screw System | Depuy, Inc. | HWC | Class II | |
| K961210 | Sam Facial Implant | W. L. Gore & Associates, Inc. | LZK | Class II | |
| K961170 | Breast Treatment Aid | S. and H. Engineering, Inc. | IYE | Class II | |
| K961134 | Bard Graft Sizer | C.R. Bard Inc | DSY | Class II | |
| K961121 | Kinematic Knee Device/magnetom Open System | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K961100 | Micro Anastomosis Clamp | R.S.P. Medical Management, Inc. | DXC | Class II | |
| K961060 | Aristo Esophageal Stethoscope | Aristo Medical Products, Inc. | BZT | Class II | |
| K955550 | Cardifix Ez Bipolar/unipolar Endocardial Pacing Lead | Intermedics, Inc. | DTB | Class III | |
| K961967 | Sas Salmonella O Poly B Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961966 | Sas Salmonella O Group X Factor 47 Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961964 | Sas Salmonella O Group H Factors 14,24,25 Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961963 | Sas Salmonella O Group W Factor 45 Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961962 | Sas Salmonella O Group V Factor 44 Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961961 | Sas Salmonella H F,g,t Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961960 | Sas Salmonella H Z4, Z24 Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961958 | Sas Salmonella H Z4 Complex Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961957 | Sas Salmonella H Z4, Z32 Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961956 | Sas Salmonella H G,m,q Antisermu | SA Scientific, Ltd | GRM | Class II | |
| K961955 | Sas Salmonella H Z42 Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961954 | Sas Salmonella H Z35 Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961953 | Sas Salmonela H Z24 Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961952 | Sas Salmonella O Factor /O Group a Factor 2 Antiserums | SA Scientific, Ltd | GRM | Class II | |
| K961951 | Sas Salmonella O Factor 6 Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961950 | Sas Salmonella O Factor 15 Antiserum &/or O Group E2 Factor 15 Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961949 | Sas Salmonella O Factor 14 Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961948 | Sas Salmonella O Factor 20 Antiserum | SA Scientific, Ltd | GRM | Class II | |
| K961456 | Playtex Tampons #10296 | Playtime Products, Inc. | HIL | Class II | |
| K961412 | Ck-Mb Method for the Technicon Immuno 1 System in-Vitro | Bayer Corp. | JHY | Class II | |
| K961389 | Polypropylene Nonabsorbable Surgical Sutures | R. K. Medical L. L. C. | GAW | Class II | |
| K961379 | Depuy Amk Porous Coated Crx Tibial Tray (1988-20/28-000 and 1988-20/28-501) | Depuy, Inc. | JWH | Class II | |
| K961375 | Dia Screen 10 Way Reagent Strips | Genesis Labs, Inc. | JIL | Class II | |
| K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | GEX | Class II | |
| K961270 | Heartport Endosinus Catheter | Heartport, Inc. | DWF | Class II | |
| K961245 | Heartport Endopulmonary Vent | Heartport, Inc. | DWF | Class II | |
| K961155 | Solo Picc/midline Catheter Kit Models 71924, 71908 | Douglas Medical Products, Inc | LJS | Class II | |
| K960802 | Cushman Manufacturing, Inc. Ultra 6.0. | Cushman Mfg., Inc. | IMI | Class II | |
| K960634 | Titanium Healing Caps | Straumann USA, LLC | DZE | Class II | |
| K960281 | Implantable Pacing Leads/implantable Accessory/non-Implantable Accessory | Intermedics, Inc. | DTB | Class III | |
| K955457 | Digiscan 2 Plus | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K955446 | Conmed Vcare Retractor/elevator | Conmedcorp | LKF | Class II | |
| K950944 | Ambulatory (Holter) Recording System | Biosensor Corp. | DQK | Class II | |
| K961510 | Acs Frt4 Immunoassay | Ciba Corning Diagnostics Corp. | JJX | Class I | |
| K961242 | Amo Phacoflex II Intersection System | Allergan | KYB | Class I | |
| K961208 | 0.6Cc Ionization Chamber - Waterproof 0.6Cc Ionization Chamber | Ptw-New York Corp. | IYE | Class II | |
| K961193 | Full Frame Zoom System | Xre Corp. | JAA | Class II | |
| K961191 | Coliscreen | Hardy Diagnostics | JTO | Class I | |
| K961090 | Automatic Visual Field Plotter Ap-125 | Kowa Pharmaceuticals America, Inc. | HPT | Class I | |
| K961055 | CT Prospeed Ct/i | GE Healthcare | JAK | Class II | |
| K961009 | Stresswriter Exercise Testing System | Hewlett-Packard Co. | DQK | Class II | |
| K960899 | Imcor 5.00 Mm Hex Self-Tapping Screw W/cover Screw | Imcor | DZE | Class II |