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 |
|---|---|---|---|---|---|
| K232856 | Syngo Carbon Clinicals | Siemens Healthcare GmbH | QIH | Class II | |
| K232758 | Comatryx OTC | Strukmyer Medical | KGN | Unclassified | |
| K232708 | Intense pulsed light therapy device | Hebei Zhemai Technology Co.,Ltd | ONF | Class II | |
| K232438 | Dental Glass Ceramics Blocks | Aibodent Biotechnology Co., Ltd. | EIH | Class II | |
| K232418 | Single Platform SP1 Implant System | Southern Implants, (Pty.) Ltd. | DZE | Class II | |
| K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14 | PENTAX of America, Inc. | ODC | Class II | |
| K232093 | Woo More Play Coconut Love Oil | Woo Essentials, Inc. | NUC | Class II | |
| K231817 | AlignerFlow LC | Voco GmbH | DYH | Class II | |
| K231476 | TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System | Sinocare, Inc. | NBW | Class II | |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | OSSIO, Ltd. | HTY | Class II | |
| K231211 | Medline ComfortTemp Patient Warming System | MEDLINE INDUSTRIES, LP - Northfield | DWJ | Class II | |
| K231179 | Slinky Catheter | Anoxia Medical, Inc. | QJP | Class II | |
| K231057 | Antibacterial Gel Wound Dressing | Winner Medical Co., Ltd. | FRO | Unclassified | |
| K230988 | Vial2Bag Advanced® 13mm Admixture Device | West Pharma. Services IL, Ltd. | LHI | Class II | |
| K230639 | Align Cervical Interbody Fusion System | Acuity Surgical Devices, LLC | ODP | Class II | |
| K230621 | LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes | Surgical Principals, Inc. | GEI | Class II | |
| K230528 | Extension Set | Medcaptain Life Science Co., Ltd. | FPA | Class II | |
| K230391 | BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube | Becton Dickinson & Co | JKA | Class II | |
| K233552 | IDEAL Ziploop | Riverpoint Medical, LLC | MBI | Class II | |
| K233545 | EPIQ Series Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K233503 | 14F iSLEEVE Introducer Set | Boston Scientific Corporation | DYB | Class II | |
| K233500 | Benesta Tissue Removal Device | Caldera Medical, Inc. | HIH | Class II | |
| K232716 | Q-Switched Nd:Yag laser | Hebei Zhemai Technology Co.,Ltd | GEX | Class II | |
| K232709 | Diode laser therapy device | Hebei Zhemai Technology Co.,Ltd | GEX | Class II | |
| K232611 | TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System | Life Spine | MAX | Class II | |
| K232262 | LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) | Surgease Innovations Ltd | FAN | Class II | |
| K232155 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K231877 | NavaClick Injection System | Lineage Biomedical, Inc | FMF | Class II | |
| K231546 | Somfit | Compumedics Limited | MNR | Class II | |
| K231393 | Radical the Dude 7F Guide Catheter | Maduro Medical, Inc. | QJP | Class II | |
| K230669 | L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters | Argon Medical Devices, Inc | LJS | Class II | |
| K230587 | Wrist Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | DQA | Class II | |
| K230061 | Insulin Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | FMF | Class II | |
| K221787 | Auxein's DHS/DCS Plate System | Auxein medical Private Limited | KTT | Class II | |
| K233532 | MULTIX Impact E | Siemens Medical Solutions | KPR | Class II | |
| K233527 | Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC | PEK | Class II | |
| K232772 | Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2) | Shenzhen Plinma Technology Co., Ltd. | DXQ | Class II | |
| K232684 | Surgify Halo | Surgify Medical Oy | HBE | Class II | |
| K232244 | Disposable Endoscope Valves System | Changzhou Endoclean Medical Device Co., Ltd. | ODC | Class II | |
| K232069 | Expandable Lumbar Fusion Cage (Type I,Type II) | Shanghai Reach Medical Instrument Co., Ltd | MAX | Class II | |
| K232033 | HYBRIDknife® flex | ERBE Elektromedizin GmbH | GEI | Class II | |
| K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) | Transit Scientific, LLC | KRA | Class II | |
| K231482 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | |
| K231203 | Mosie Baby Kit | Mosie Baby | QYZ | Class II | |
| K230726 | CEREGLIDE 92 Intermediate Catheter | Cerenovus, Inc. | QJP | Class II | |
| K230646 | SUREcore Prime Biopsy Instrument | Uro-1 Medical, Inc. | KNW | Class II | |
| K230179 | 6440 MyLabX90 | Esaote S.p.A. | IYN | Class II | |
| K233493 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024) | Relign Corporation | GEI | Class II | |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | SeaSpine Orthopedics Corporation | OVE | Class II | |
| K232713 | Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co.,Ltd | DXN | Class II |