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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K831622 | Morhel Closed Urinary Drainage Set | Morhel Mexicana | KNX | Class II | |
| K831613 | Magic Tm 125I T3 Uptake Radioassay | Corning Medical & Scientific | KHQ | Class II | |
| K831599 | Meritec-Strep Group a Beta-Hemolytic | Meridian Diagnostics, Inc. | GTY | Class I | |
| K831151 | Panasonic Model Ew-213 | Panasonic Co. Div. Matsu Elec. Corp. America | DXN | Class II | |
| K830869 | Polychaco Indirect Immunofluorescence | Parasitic Disease Consultants | GLZ | Class II | |
| K830741 | Parametric Sterility Release of Auto | United Surgical LLC | GAG | Class II | |
| K830682 | Cardivan Blood Pressure Monitor | Paramed Technology, Inc. | DXN | Class II | |
| K832003 | Aqueous Blood Gas Control Level i,ii & | American Dade | JJS | Class I | |
| K831567 | Foley-Temp | Mallinckrodt Critical Care | KOD | Class II | |
| K831389 | Stat-Trak Liquid Electrolyte Control | United Diagnostics, Inc. | JJR | Class I | |
| K831330 | Universal Coronary Cannula | Possis Medical, Inc. | DWF | Class II | |
| K832233 | Epineed Epidural Needle | Terumo Medical Corp. | BSP | Class II | |
| K832232 | Epineed Epidural Catheter | Terumo Medical Corp. | BSO | Class II | |
| K832203 | Multi-Titer Dispenser | Hamilton Co | JTC | Class I | |
| K832165 | Improved Silicath Silicone Elastomer | Travenol Laboratories, S.A. | KOD | Class II | |
| K832128 | Self-Seal Sterilization Pouches | Medical Industries Packaging, Inc. | KCT | Class II | |
| K832117 | Immulon Substrate Removawell Strips | Dynatech Corp. | LIB | Class I | |
| K832096 | Emit Cad Quinidine Assay for Use W/ | Syva Co. | LBZ | Class II | |
| K832064 | Venous Catheter | Cardio Search, Inc. | DQY | Class II | |
| K832056 | Emit Amd Gentamicin Assay | Syva Co. | LCD | Class II | |
| K832055 | Emit Assay and Tobramycin | Syva Co. | LDO | Class II | |
| K832052 | Model 327T Unipolar Cardiac Pulse Gen | Cook Pacemaker Corp. | DXY | Class III | |
| K832027 | Argyle Yankaver Suction Tube W/control | Sherwood Medical Co. | JOL | Class II | |
| K832002 | Nml-5010/5020 Multi-Detector System | Nuclear Medical Laboratories, Inc. | JJJ | Class I | |
| K831995 | Trendo-Scope | Gabriel Ent. | HCS | Class II | |
| K831994 | Biocheck Positive Urine Control | Helena Laboratories, Corp. | JJW | Class I | |
| K831989 | Visidex II Reagent Strips | Miles Laboratories, Inc. | CGA | Class II | |
| K831986 | Metal-Backed Ace Tabular Cup | Kirschner Medical Corp. | JDI | Class II | |
| K831983 | Data-Zyme Uric Acid Procedure | Data Medical Associates, Inc. | KNK | Class I | |
| K831940 | Gamma Sterilized Capillary Flow Dialyz | Travenol Laboratories, S.A. | FKQ | Class II | |
| K831935 | Enternal Pump & Admin. Set 430 | Imed Corp. | FRN | Class II | |
| K831821 | Pneumatic/electric/hydraulic Bed | G.W. Healthcare, Inc. | FNL | Class II | |
| K831796 | Urine Bag System | I M, Inc. | KNX | Class II | |
| K831760 | Legionella Ifa Kit I | Bionetic Laboratory Products | LHL | Class II | |
| K831660 | Ams Malleable Penile Prosthesis | American Medical Systems, Inc. | FAE | Class II | |
| K831640 | Washer 6000 Micro-C Lisa System | bioMerieux, Inc. | JTC | Class I | |
| K831496 | Allergen Immunosorbents Ip Specific E | Diagnostic Reagent Tech. | |||
| K831457 | Auto Suture Poly Surgiclip Hemostatic | United States Surgical, A Division of Tyco Healthc | FZP | Class II | |
| K831402 | Pressure Monitor & Control Unit Apc-02A | Parker Hannifin Corp. | KXM | Class II | |
| K831343 | Cmv Rq Bio-Enzabead Kit | Litton Bionetics | LFZ | Class II | |
| K831132 | Compudial/kp-1 | Computer Dialysis Systems, Inc. | LIF | Class II | |
| K831053 | Quantigen T & B Cell Assay | Bio-Rad | LIZ | Class II | |
| K831000 | Medion Mi-200 Iontophoretic Medicator | Etherington Industries | |||
| K830541 | Injection Sealing Cap 13791 | Quinton, Inc. | FOZ | Class II | |
| K832161 | Ambulizer Model Mc-5 | Mobilizer Medical Products, Inc. | IOR | Class I | |
| K832144 | Splint Wood | Vermont Wood Industries, Inc. | ILH | Class I | |
| K832142 | Dicon Glaucoma Diag. Center 2000 Series | CooperVision, Inc. | HPT | Class I | |
| K832081 | Phonic Ear Pe 845Ppc-D | Phonic Ear, Inc. | ESD | Class I | |
| K832080 | Phonic Ear Pe 467R-Pe 461T | Phonic Ear, Inc. | EPF | Class II | |
| K832074 | Cavitron/kelman Phaco-Emulsifier Aspira | CooperVision, Inc. | HKP | Class II |