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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K771555 | Peritoneal Dialysis Catheter | Fluoro-Mold Co. | FJS | Class II | |
| K771483 | Catheter Finger Grip | Quinton, Inc. | FJS | Class II | |
| K771420 | Beta-Cap | Quinton, Inc. | FJS | Class II | |
| K771413 | Ligaclip Multiple Ligating Clips | Ethicon, Inc | FZP | Class II | |
| K771412 | Ligaclip Multiple Clip Applier | Ethicon, Inc | GDO | Class I | |
| K772086 | Quantrols Hcg | Organon LLC | JHI | Class II | |
| K772047 | Respiratory Kit | American Hospital Supply | CAH | Class II | |
| K772046 | Intubation Procedure Kit | American Hospital Supply | BSR | Class I | |
| K772039 | Beta-Hcg Ria | Monitor Science Corp. | JHI | Class II | |
| K772005 | Myotone EMG Monitor | Micro Tronics Corp. | IKN | Class II | |
| K771978 | Ctr 100L | Emi Medical, Inc. | JAK | Class II | |
| K772167 | Emit Lidocaine Control | Syva Co. | DLJ | Class II | |
| K772166 | Emit Theophylline Control | Syva Co. | DLJ | Class II | |
| K772158 | Light-Pen System for Quanti. Analy. | Varian Assoc., Inc. | DXG | Class II | |
| K772149 | Lancer Biopsy Holder | Sherwood Medical Industries | KER | Class I | |
| K772132 | Amplifier Module, 78211A ECG | Hewlett-Packard Co. | DRR | Class II | |
| K772128 | Fluorescein Conjugated | Kallestad Laboratories, Inc. | DCE | Class I | |
| K772110 | In Vitro Digoxin Ria Test | Clinical Assays, Inc. | DNL | Class II | |
| K772097 | Heartrate Meter Model 650, P/n 000119 | Quinton, Inc. | DRT | Class II | |
| K772096 | In Vitro Diagnostic Reagent | Pcl-Ria, Inc. | CDX | Class II | |
| K772056 | Physiological Monitor Model 871 | Datascope Corp. | DRT | Class II | |
| K772054 | Physiological Recorder Model 740 | Datascope Corp. | DSF | Class I | |
| K772052 | Physiological Recorder Model 721A | Datascope Corp. | DSF | Class I | |
| K772000 | ECG Telemetry System | Mennen Greatbatch Electonics | DRG | Class II | |
| K771996 | Telethermometer Model T T-100 | Electromedics, Inc. | FLL | Class II | |
| K771995 | Electrotherm Models Tc-100 & M-99 | Electromedics, Inc. | FLL | Class II | |
| K771955 | Trypsin 1% | Flow Laboratories, Inc. | IBG | Class I | |
| K771864 | Wall Transformers 74710 & 74910 | Welch Allyn Inc | GCW | Class II | |
| K771843 | Wetting Agents | Gamma Enterprises, Inc. | |||
| K771836 | Lactate Dehydrogenase | Gamma Enterprises, Inc. | CFJ | Class II | |
| K771832 | Chloride | Gamma Enterprises, Inc. | JFS | Class II | |
| K771742 | Evoked Response Sys., Model 10 | Grass Instrument Co. | GWK | Class II | |
| K771723 | Hill Tube | Physio Control, Inc. | KLA | Class II | |
| K771678 | Thrombo-Screen Platelet Adhesion | Bay Area Hema. Onco. Clinic. & Res. L | JBZ | Class II | |
| K771523 | Latelet Retention Column | BD Becton Dickinson Vacutainer Systems Preanalytic | JBZ | Class II | |
| K771265 | Pressure Monitor Manometric Sys. | Physio Control, Inc. | KLA | Class II | |
| K771102 | UV Glucose Determ., Auto Chem. Analyzers | The Dow Chemical Co. | LFR | Class II | |
| K772137 | Vein Clamps | A&A Ent. | DXC | Class II | |
| K772125 | Tomographic Scanner, Computerized | Emi Medical, Inc. | JAK | Class II | |
| K772123 | Tomographic System, Computerized | Philips North America LLC | JAK | Class II | |
| K772103 | Bipolar Leads, Disp. | Medtronic, Inc. | DTB | Class III | |
| K772102 | Amplifier Otrona, Model N3a-EMG | Honeywell, Inc. | GWL | Class II | |
| K772101 | Hearing Aid-Model Pe-1 | Starkey Laboratories, Inc. | ESD | Class I | |
| K772100 | Hearing Aid-Model Ce-2 | Starkey Laboratories, Inc. | ESD | Class I | |
| K771962 | Camera Adapter for Endoscopes | Kli | HET | Class II | |
| K772093 | Impedance Rheograph | Dynatech Research & Development Co. | DQB | Class II | |
| K772092 | Chest Fluid Monitor | Dynatech Research & Development Co. | DSB | Class II | |
| K772023 | Ob/gyn Laser, Model 920 | Photon Sources | HHR | Class II | |
| K772122 | T3 Ria Kit | Antibodies, Inc. | CDP | Class II | |
| K772121 | Aspirator & Probe, Cytology, Endomet. | Smithkline Diagnostics, Inc. | HHK | Class II |