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 | 2,669 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K151947 | LightSheer Desire Light Laser System | Lumenis Ltd | GEX | Class II | |
| K151935 | Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only | Alere San Diego, Incorporated | LYR | Class I | |
| K151929 | Persyst 13 (P13) EEG Review and Analysis Software | Persyst Development LLC | OMB | Class II | |
| K151859 | Synapse Cardiovascular | FUJIFILM Healthcare Americas Corporation | LLZ | Class II | |
| K151776 | Central Venous Pressure System | Mespere Lifesciences Inc. | PFA | Class II | |
| K151663 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | IYN | Class II | |
| K151462 | Si-Technology® Si-Desis® Screws | SI-Technology, LLC | OUR | Class II | |
| K151407 | RECON system | Normed Medizin-Technik GmbH | HRS | Class II | |
| K151256 | Arthrex BioSync® Bone Wedge | Arthex, Inc. | PLF | Class II | |
| K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System | Highridge Medical, LLC | OVE | Class II | |
| K150564 | Spaulding Electrocardiograph 2100iQ | Spaulding Clinical Research, LLC | DPS | Class II | |
| K151850 | McKesson Cardiology | Change Healthcare Israel Ltd. | LLZ | Class II | |
| K150757 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K150745 | syngo.CT Single Source Dual Energy | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K143583 | Cathivex ¿GV filter units | Merck Millipore Ltd. | FPB | Class II | |
| K143148 | Disposable Pressure Manometer (DPM) | Westmed Inc | CAP | Class II | |
| K142765 | Tm Safety Needle | Thinkmed Medical Technology Co., Ltd. | FMI | Class II | |
| K151586 | Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens | Yung Sheng Optical Co., Ltd. | LPL | Class II | |
| K151264 | Restoration Anatomic Shell | Stryker Orthopaedics | LPH | Class II | |
| K151247 | NC Straumann Screw Retained Abutments | Straumann USA, LLC | NHA | Class II | |
| K151216 | Everest Spinal System | K2M, Inc | NKB | Class II | |
| K151057 | WASTON Metallic Bone Plate and Screw Systems | Changzhou Waston Medical Appliance Co., Ltd. | HRS | Class II | |
| K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides | Materialise N.V. | JWH | Class II | |
| K150814 | Straumann Screw-Retained Abutment | Straumann USA, LLC | NHA | Class II | |
| K150395 | Omega LIF System | Spinal Elements, Inc | MAX | Class II | |
| K141594 | Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar | Unimicro Medical Systems (Shenzhen) Co., Ltd. | GCJ | Class II | |
| K152054 | Confida Adaptive Sheath | Medtronic, Inc. | DYB | Class II | |
| K151924 | Q-Rad Radiographic System with Auto-Tracker Option | Quantum Medical Imaging Divison of Carestream | KPR | Class II | |
| K151880 | Wingman Crossing Catheter | ReFlow Medical, Inc | DQY | Class II | |
| K151877 | MicroTract Access System | Arstasis, Inc. | DRE | Class II | |
| K151867 | Sta R Max | Diagnostica Stago S.A.S | JPA | Class II | |
| K151863 | Precision Spine Interspinous Plate System | Precision Spine, Inc. | PEK | Class II | |
| K151657 | Shielded Applicator Set, Cervical Stop | Varian Medical Systems, Inc. | JAQ | Class II | |
| K151653 | 8ch Foot Ankle Coil | Shenzhen RF Tech Co., Ltd. | MOS | Class II | |
| K151587 | Digital Automatic Wrist Blood Pressure Monitor MD3200 | Grandway Technology (Shenzhen) Limited | DXN | Class II | |
| K151583 | Digital Automatic Wrist Blood Pressure Monitor MD3900 | Grandway Technology (Shenzhen) Limited | DXN | Class II | |
| K151409 | Selectra Catheters and Selectra Accessory Kit | BIOTRONIK AG | DQY | Class II | |
| K151373 | Corvocet Coaxial Introducer | Merit Medical Systems, Inc. | FCG | Class II | |
| K151369 | .decimal p.d | .Decimal, Inc. | MUJ | Class II | |
| K151353 | syngo.MR Neurology, syngo.MR Oncology | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K151241 | Synchro-Medical TIGER TRACK Screw System | Synchro Medical | HWC | Class II | |
| K151164 | Assure Prism multi Blood Glucose Monitoring System | I-SENS, Inc. | NBW | Class II | |
| K150665 | Philips Spectral CT Applications | Philips Medical Systems Nethrlands BV | JAK | Class II | |
| K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream | Guangzhou Wondfo Biotech Co., Ltd. | LCX | Class II | |
| K143758 | PerioType Rapid | Clinical House Europe GmbH | DZE | Class II | |
| K143017 | Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver | Laboratoires Urgo | FRO | Unclassified | |
| K140907 | Leech, Medicinal | Carolina Biological Supply Co. | NRN | Unclassified | |
| K151897 | MultiFIX® P Knotless Fixation Device | ArthroCare Corporation | MBI | Class II | |
| K151879 | VariAx 2 One-Third Tubular Plating System | Stryker Corp. | HRS | Class II | |
| K151856 | ABL80 FLEX CO-OX with AQURE connectivity | Sendx Medical, Inc. | CHL | Class II |