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 |
|---|---|---|---|---|---|
| K993802 | Sharpview Image Enhancement System | Context Vision AB | LLZ | Class II | |
| K993720 | Cordis Maxi Ld Large Diameter Balloon Dilatation Catheter | Cordis US Corp. | KNQ | Class II | |
| K993659 | Renamel Pack | Cosmedent, Inc. | EBF | Class II | |
| K993658 | Renamel Sculpt | Cosmedent, Inc. | EBF | Class II | |
| K993614 | Fas Endoluminal Brush | Fas Medical, Ltd. | LJS | Class II | |
| K993599 | Diagnostic Pro, Model 12772, Vxr-16, Model 13020, Vxr-16 Dosimetry Pro, Model 13019 | Vidar Systems Corp. | LMA | Class II | |
| K993574 | Opart/prodiga, Opart/protenza, Opart/paragon | Toshiba America Mri, Inc. | LNH | Class II | |
| K993239 | Stryker Navigation System - Neuro Module, Model 6000-Xxx-Xxx | Stryker Corp. | HAW | Class II | |
| K992901 | Gynecare Versapoint G-Vap Electrode | Gynecare, Inc. | HIH | Class II | |
| K992811 | Transducers for Ultrasound and Tocodynamometer Fetal Monitoring | Epic Medical Equipment Services, Inc. | HFM | Class II | |
| K992727 | The Bi-Directional Spiral & Epoxy Root Canal Cement System | Mds | KIF | Class II | |
| K992658 | Osom Ultra Strep a Test, Model 147 | Wyntek Diagnostics, Inc. | GTY | Class I | |
| K992573 | Af-220 Hemodialyzer | Althin Medical AB | KDI | Class II | |
| K992566 | Af-150 Hemodialyzer | Althin Medical AB | KDI | Class II | |
| K992564 | Af-180 Hemodialyzer | Althin Medical AB | KDI | Class II | |
| K992563 | A-22 Hemodialyzer | Althin Medical AB | KDI | Class II | |
| K992448 | V.a.c. Plus | KCI USA, Inc. | OMP | Class II | |
| K991936 | 3.0 Ml Reservoir, Model 103/193 | Medtronic, Inc. | FRN | Class II | |
| K991861 | 1St Response Infant Manual Resuscitator, Bag Resevoir, 1St Response Pediatric Manual Resuscitator, Bag Reservoir, 1St Re | Abbott Medical | BTM | Class II | |
| K991390 | 1.5 M Propanediol Freezing Medium, 1.5 Propanediol 0.1 Sucrose Freezing Medium, 9% Glycerol, 0.2 M Sucrose Freezing Medi | Sage Biopharma | MQL | Class II | |
| K990445 | Lpg Therapeutic Massager, Models -Esi, Therapeutic Massager/vibrator | Lpg USA, Inc. | ISA | Class I | |
| K984083 | Multifunction Keito K5 | Bumedco Intl., Inc. | DXN | Class II | |
| K994439 | Access Ck-Mb on the Access Immunoassay Analyzer, Models 33300, 33305, 33309, 33306 | Siemens Healthcare Diagnostics Inc. | JHX | Class II | |
| K994388 | Xe Check | Streck Laboratories, Inc. | GLQ | Class II | |
| K994316 | Magnetom Open Viva with Permanent Magnet | Siemens Medical Corp. | LNH | Class II | |
| K994277 | Access Ostase Qc | Siemens Healthcare Diagnostics Inc. | JJX | Class I | |
| K994073 | Hemosite Test System | Gds Technology, LLC | KHG | Class II | |
| K994067 | Hardy Disk Ampicillin/sulbactam | Hardy Diagnostics | JTN | Class II | |
| K994063 | Hardydisk Aztreonam, 30Mcg | Hardy Diagnostics | JTN | Class II | |
| K993927 | Wako Iga II-Ha, Immunoglobulin Calibrator Set, Immunoglobulin Standrad | FUJIFILM Healthcare Americas Corporation | CZP | Class II | |
| K993924 | Wako Igm II- Ha, Immunolobulin Calibrator Set, Immunolobulin Standard | FUJIFILM Healthcare Americas Corporation | CFN | Class II | |
| K993679 | Microstrep Plus Panel - Haemophilus/ampicillin | Dade Microscan, Inc. | JWY | Class II | |
| K993519 | Rapidpoint Accent, Model 2000, Rapidpoint Coag Heparin Titration Test, Rapidpoint Coag Protamine Response Test | Cardiovascular Diagnostics, Inc. | JOX | Class II | |
| K993238 | Fortoss-Cema | Biocomposites, Ltd. | LYC | Class II | |
| K992851 | Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro System | Roche Diagnostics GmbH | JBP | Class II | |
| K992785 | Ibc Floguard, Model 6050 | International Biophysics Corp. | MJJ | Class II | |
| K992749 | Ultraview Waveform Pager System, Model 91841 | GE Healthcare | MSX | Class II | |
| K992684 | Freestyle Blood Glucose Monitoring System | Abbott Medical | LFR | Class II | |
| K992007 | Pharmaseed, Model Bt-103-1 | Syncor Pharmaceuticals, Inc. | KXK | Class II | |
| K991916 | Virginia Water Systems' Water Purification System for Hemodialysis | Virginia Water Systems, Inc. | FIP | Class II | |
| K984551 | Infrared Ear Thermometer, Model Ki-8120 | K-Jump Health Co., Ltd. | FLL | Class II | |
| K983953 | Microstrep Plus Panel, Vancomycin | Dade Microscan, Inc. | JWY | Class II | |
| K994358 | Atw Marker Wire Steerable Guidewire | Cordis US Corp. | DQX | Class II | |
| K994313 | Modification to Bone Anchor and Kit (Bak) | TORNIER Inc. | GAW | Class II | |
| K994241 | Trx-Cg Power Tilt and Recline System | Motion Concepts LP | ITI | Class II | |
| K994208 | Affinity 20 Micron Arterial Blood Filter, Model 353/354 | Medtronic Perfusion Systems | DTM | Class II | |
| K994185 | Manual Wheelchair | Major Mobility Products, Inc. | IOR | Class I | |
| K994107 | Amysystems Pts50-50 Degree Power Tilt System for Mid-Wheel or Front-Wheel Drive Power Wheelchairs. | Amylior, Inc. | ITI | Class II | |
| K994072 | Amysystems Pts50cg 50 Degree Weight Shift Power Tilt System | Amylior, Inc. | ITI | Class II | |
| K994048 | Portable Light Curing Unit | Gregory S. Jacob, D.D.S. | EBZ | Class II |