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 |
|---|---|---|---|---|---|
| K062825 | Aos Marker Seeds | Alpha Omega Services Inc | KXK | Class II | |
| K071188 | Modification to Jbaids Anthrax Detection System | Idaho Technology, Inc. | NHT | Class II | |
| K071076 | Synergies Plus Gram-Positive Mic/combo Panels | Siemens Healthcare Diagnostics Inc. | LON | Class II | |
| K071006 | Heartway Attendant-Controlled Power Chair, Tc1 | Heartway Medical Products Co., Ltd. | ITI | Class II | |
| K070759 | Powered Ez-Io Pediatric Bone Marrow Aspiration System | Teleflex Medical | FCF | Class II | |
| K070536 | Medilas D Family Lasers | Dornier Medtech America, Inc. | GEX | Class II | |
| K070295 | Single Planar Multi Axial (Spma) Pedicle Screw System | Trinity Orthopedics, LLC | MNI | Class II | |
| K063494 | Doro Radiolucent Headrest System ( Also MRI-Compatible) and Components | Black Forest Medical GmbH | HBL | Class II | |
| K071267 | Periosrp Tooth Root Conditioner with Novamin | Novamin Technology, Inc. | LBH | Class II | |
| K071229 | Senorad Multi-Lumen Balloon Source Applicator for Branchytherapy | Senorx, Inc. | JAQ | Class II | |
| K071204 | Site-Rite 6 Ultrasound System, Model Site-Rite 6 | C.R. Bard Inc | IYO | Class II | |
| K071117 | Modification to Pinnacle Constrained Acetabular Liners | Depuy Orthopaedics Inc. | KWZ | Class II | |
| K071095 | Aspira Pleural Drainage System | Bard Access Systems, Inc. | DWM | Class II | |
| K071077 | .Decimal Aperture | .Decimal, Inc. | IXI | Class II | |
| K070990 | Apex Medical Mobineb, 9R-027 Series | Apex Medical, Inc. | CAF | Class II | |
| K070964 | Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination System | Welch Allyn Inc | HIB | Class II | |
| K070834 | Cs-Series Fluoroscopy System, Cs-10 Through Cs-65 (11 Configurations) | Omega Medical Imaging, LLC | OWB | Class II | |
| K070688 | Nexfix Compression Staple | Nexa Orthopedics, Inc. | JDR | Class II | |
| K070565 | Cofield Total Shoulder System | Smith & Nephew, Inc. | MBF | Class II | |
| K070562 | Ez Plus Implant System | Megagen Co., Ltd. | NHA | Class II | |
| K070235 | Bodyguard Pain Manager Infusion System | Caesarea Medical Electronics, Ltd. | FRN | Class II | |
| K070180 | Wallaby 4 | Respironics Inc., Sleep & Home Respiratory Group | LBI | Class II | |
| K070047 | Nunc Ivf Dishes and Nunc Ivf 4-Well Dish | Nunc A/S | MQK | Class II | |
| K063668 | Roc Lumbar System | Alphatec Spine, Inc. | MNI | Class II | |
| K062563 | Femten Cervical Tenaculum | Fem Suite, LLC | HDC | Class II | |
| K071231 | Edac Quantifier | Luna Innovations, Inc. | KRL | Class II | |
| K071217 | Bladderscan Bvi 9400 Ultrasound | Verathon Incorporated | IYO | Class II | |
| K071115 | Modification to Bilok St Screw | Biocomposites, Ltd. | HWC | Class II | |
| K071091 | Modification to Bilok Screw | Biocomposites, Ltd. | HWC | Class II | |
| K070645 | Seradyn Qms Topiramate | Seradyn, Inc. | NWM | Class II | |
| K070284 | Fralex Sr 1500 Laser System (Fralex II Sr Laser System) | Reliant Technologies, Inc. | GEX | Class II | |
| K063806 | Sleepnet Mojo -Nv Full Face Mask, Non-Vented | SleepNet Corporation | CBK | Class II | |
| K071295 | 100W Ceralas D 980Nm Diode Laser | Biolitec, Inc. | GEX | Class II | |
| K071189 | Cordis Aviator Plus Pta Balloon Dilatation Catheter | Cordis Europa, N.V. | LIT | Class II | |
| K071061 | Absorbatack and Applicator | Sorbx, LLC | GDW | Class II | |
| K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound di | IYN | Class II | |
| K070997 | Doro Non-Stick Bipolar Forceps, Model 5001-Xx to 5012-Xx, Doro Bipolar Reusable Cables, Model 5015-Xx | Black Forest Medical GmbH | GEI | Class II | |
| K070908 | Smith & Nephew Kinsa Rc Suture Anchor | Smith & Nephew, Inc. | MBI | Class II | |
| K070885 | Universal Taper Delta Femoral Head | Howmedica Osteonics Corp | LZO | Class II | |
| K070758 | Stryker Peek Zip Suture Anchor | Stryker Corp. | MBI | Class II | |
| K070724 | Ios External Fixator, Model 2-0-0 | Intelligent Orthopaedics, Ltd. | KTT | Class II | |
| K070457 | Sun Scientific Llc-Leg Compressor and Pfab | Sun-Scientific Inc. | MHW | Class I | |
| K070024 | Thor Vr Single Diode Laser Treatment Probe, Model 200 Mw Single Vr Diode Probe | Thor International | ILY | Class II | |
| K063764 | Southern Spine Anterior Cervical Stabilization System, Kwik- Fix Cervical System, and Kwik-Fix / Ts Cervical System | Southern Spine, LLC | KWQ | Class II | |
| K063104 | Fox Medical Diode Laser System 810Nm | Howard Instruments, Inc. | GEX | Class II | |
| K062525 | Reprocessed Ligasure Vessel Sealer/divider | Stryker Sustainability Solutions | GEI | Class II | |
| K071048 | Rubicor Magic Breast Biopsy Device, Model 31537 | Rubicor Medical, Inc. | KNW | Class II | |
| K070868 | Lms-Lung/track | Median Technologies | LLZ | Class II | |
| K070861 | Powder Free Nitrile Examination Gloves, Blue | Hong Xin Rubber Products Co., Ltd. | LZA | Class I | |
| K070840 | Gvc-100 | GC America Inc. | EMA | Class II |