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 |
|---|---|---|---|---|---|
| K152928 | Multitom Rax | Siemens Medical Solutions USA, Inc. | OWB | Class II | |
| K152757 | SIGN Hip Construct (SHC) | SIGN Fracture Care International | HSB | Class II | |
| K152723 | Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices | Hologic, Inc. | HIH | Class II | |
| K152277 | PIVOX(tm) Oblique Lateral Spinal System | Medtronic Sofamor Danek USA Inc | MAX | Class II | |
| K152270 | Denture base resin | Korea Engineering Plastics Co., Ltd. | EBI | Class II | |
| K151974 | Polaris Spinal System | Highridge Medical, LLC | NKB | Class II | |
| K151667 | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm | Stryker Corp. | DQY | Class II | |
| K151638 | Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter | Cathera, Inc. | DQY | Class II | |
| K151275 | MAKO Device | Nvision Medical | HIH | Class II | |
| K150488 | Humelock II Reversible Shoulder System | Fx Shoulder Solutions SAS | PHX | Class II | |
| K150436 | ComboRehab | Shenzhen Dongdixin Technology Co., Ltd. | IMG | Class II | |
| K150353 | Btl-4000 | BTL Industries, Inc | IMG | Class II | |
| K152983 | FUJIFILM SonoSite iViz Ultrasound System | FUJIFILM SonoSite,Inc. | IYN | Class II | |
| K152976 | VLP Mini-Mod Talus Plates | Smith & Nephew, Inc. | HRS | Class II | |
| K152623 | ATLANTIS Anterior Cervical Plate System | Medtronic Sofamor Danek USA Inc | KWQ | Class II | |
| K152618 | PANTHER Cutter Stapler | B.j.zh.f.panther Medical Equipment Co.,Ltd | GDW | Class II | |
| K152382 | Arthrex iBalance TKA System | Arthrex GmbH | JWH | Class II | |
| K152181 | Turbo-Power Laser Atherectomy Catheter | Spectranetics Corp. | MCW | Class II | |
| K151752 | SOMATOM Emotion 6/16 | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K150800 | Valved Safety Centesis Catheter | B.Braun Medical, Inc. | GCB | Class I | |
| K150743 | Water Based Personal Lubricant with Flavours | Karex Industries Sdn Bhd | NUC | Class II | |
| K150558 | Eclipse System | Pelvalon | PJH | Class II | |
| K150388 | Dental Implant System | Bio Concept Co., Ltd. | DZE | Class II | |
| K150358 | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System | Gold Standard Diagnostics, LLC | GMQ | Class II | |
| K150298 | Entropy Module, E-ENTROPY-01 | GE Healthcare Filand Oy | OLW | Class II | |
| K153060 | Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S | Rayence Co., Ltd. | MUH | Class II | |
| K153058 | CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | MQB | Class II | |
| K152525 | TR BAND Radial Compression Device | Terumo Medical Corp. | DXC | Class II | |
| K152285 | illumigene Pertussis DNA Amplification Assay | Meridian Bioscience Inc | OZZ | Class II | |
| K152151 | Atal 9 | Atlaim | MQB | Class II | |
| K151852 | PacEndo Sodium Hyprochlorite | Pac-Dent International, Inc. | KJJ | Unclassified | |
| K151819 | Integrity Spine Lumbar Interbody Fusion System | Integrity Spine Lumbar Interbody Fusion System | MAX | Class II | |
| K151315 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | Boston Scientific Corporation | EOQ | Class II | |
| K151154 | FIBERGRAFT BG Morsels | Prosidyan, Inc. | MQV | Class II | |
| K150916 | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO | Hem Con Medical Technologies, Inc. | QSY | Unclassified | |
| K150211 | EzFuze Implant System | Vilex LLC | HWC | Class II | |
| K152551 | First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test. | WHPM Inc. | DJG | Class II | |
| K152426 | Wrist - Type Fully Automatic Digital Blood Pressure Monitor | Sejoy Electronics & Instruments Co., Ltd. | DXN | Class II | |
| K151946 | Thermofit | Orfit Industries NV | IYE | Class II | |
| K151382 | Patient Contoured Implant-PEEK (PCI-PEEK) | KLS-Martin L.P. | GXN | Class II | |
| K150397 | Divine 9 | Carrashield Labs, Inc. | NUC | Class II | |
| K153023 | Ablatherm Integrated Imaging | Edap Technomed Inc. | PLP | Class II | |
| K152567 | Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System | GE Healthcare | IYN | Class II | |
| K152203 | Utermohlen Cryo Professional | Koninklijke (Royal) Utermohlen N.V. | GEH | Class II | |
| K151928 | PUR Dental Implant System | Sterngold Dental LLC | DZE | Class II | |
| K151925 | Elation Wireguided Balloon Dilation Catheter | Merit Medical Systems, Inc. | FGE | Class II | |
| K151903 | Slendertone connect Abs | Bio-Medical Research, Ltd. | NGX | Class II | |
| K151759 | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS | The Binding Site Group Ltd. | OPX | Class II | |
| K151713 | Lillipup Pmp, Lilliput Pmp Integrated | Corcym Inc. | DTZ | Class II | |
| K151609 | ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 | NDS Surgical Imaging, LLC | GCJ | Class II |