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 |
|---|---|---|---|---|---|
| K150079 | Regenomer® Syringe, Regenomer® Plug, Regenomer® Block | Nibec Co., Ltd. | NPM | Class II | |
| K142313 | OneQ-SL Implant System | Dentis Co.,Ltd | DZE | Class II | |
| K153223 | ProParaFlu+ Assay | Hologic, Inc. | OOU | Class II | |
| K153126 | da Vinci Xi Hasson Cone | Intuitive Surgical, Inc. | GCJ | Class II | |
| K152467 | Touch Ultrasound | Eastman Kodak Company | IYN | Class II | |
| K152243 | One Coat 7 Universal | Coltene /Whaledent AG | KLE | Class II | |
| K151396 | MIVI Mi-AXUS Guide Catheter | Mivi Neuroscience, Inc. | DQY | Class II | |
| K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | Bio-Rad Laboratories Inc. | PDJ | Class II | |
| K151133 | Pentra Xlr | Horiba Abx SAS | GKZ | Class II | |
| K150668 | Biodesign Enterocutaneous Fistula Plug | Cook Biotech Incorprated | FTM | Class II | |
| K152722 | neoV980 & neoV1470 Diode Lasers | G.N.S Neolaser Ltd. | GEX | Class II | |
| K152721 | Cytal Wound Matrix | ACell, Inc | KGN | Unclassified | |
| K152146 | High Speed Handpieces and Accessories | Codent Technical Industry Co.,Ltd. | EFB | Class I | |
| K152012 | EVO platform | Quanta System Inc. | GEX | Class II | |
| K151127 | higi Station | Higi SH LLC | DXN | Class II | |
| K150716 | Varaya Sport | Varaya Photoceuticals, LLC | ILY | Class II | |
| DEN150010 | Dignitana AB DigniCap System | Dignitana AB | PMC | Class II | |
| K152783 | Merit 20 mL Syringe | Merit Medical Systems, Inc. | FMF | Class II | |
| K152624 | Xstat 30, 3-Pack, Xstat 30, 1-Pack | Revmedx Inc | PGZ | Class II | |
| K152436 | Suntanning Lamps | Interlectric Corp. | LEJ | Class II | |
| K152292 | Respire Blue Series-EF | Respire Medical Holding | LRK | Class II | |
| K151934 | ROI-C Titanium-Coated Implant System | Ldr Spine USA | OVE | Class II | |
| K151896 | Houdini Catheter | Cruzar Medsystems, Inc. | DQY | Class II | |
| K151639 | ABL80 FLEX and ABL80 FLEX CO-OX | Sendx Medical, Inc. | CGA | Class II | |
| K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | VitalConnect, Inc. | DRG | Class II | |
| K153228 | NMI Port, NMI Port II | Boston Scientific Corporation | LJT | Class II | |
| K152958 | INEX Absorbable Nasal Implant | Spirox, Inc. | NHB | Class II | |
| K152484 | FastFrame External Fixation System - Distal Radius | Zimmer GmbH | KTT | Class II | |
| K152441 | KIRO Set | Kiro Robotics S.L. | LHI | Class II | |
| K152401 | Stingray LP Catheter | Boston Scientific Corporation | DQY | Class II | |
| K152321 | kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening | Qfix | IYE | Class II | |
| K152284 | Cohitech Non Applicator Organic Cotton Tampons;cohitech Compact Applicator Organic Cotton Tampons | Cotton High Tech S.L. | HEB | Class II | |
| K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | Liaoning Upcera Co.,Ltd | EIH | Class II | |
| K152078 | Implant Studio 2015 | 3Shape Medical A/S | LLZ | Class II | |
| K151936 | Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle | Synaptic Medical Corporation | DYB | Class II | |
| K150966 | Hmb32 | Haemopharm Biofluids SRL | KPO | Class II | |
| K150961 | EmbryoSlide Culture Dish | Vitrolife Inc. | MQK | Class II | |
| K150833 | iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System | Andon Health Co., Ltd | NBW | Class II | |
| K153213 | Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | DTZ | Class II | |
| K152904 | Sydney Ivf Embryo Biopsy Medium | William A. Cook Australia Pty, Ltd. | MQL | Class II | |
| K152859 | Portable X-ray System (Model: MINIX-V / MINIX-S) | Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) | EHD | Class II | |
| K152582 | CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box | Volcano Corporation | DSK | Class II | |
| K151714 | Disposable Endoscope Valves Set A | Wilson Instruments (Shanghai) Company Limited | ODC | Class II | |
| K151226 | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) | Cepheid | OCC | Class II | |
| K153143 | Capiox Advance Hardshell Reservoir | Terumo Cardiovascular Systems Corporation | DTN | Class II | |
| K153140 | Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating | Terumo Cardiovascular Systems Corporation | DTZ | Class II | |
| K152840 | Lantern Delivery Microcatheter | Penumbra Inc. | DQY | Class II | |
| K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory | Stryker Corp. | NKB | Class II | |
| K152566 | PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors | Smith & Nephew, Inc. | MBI | Class II | |
| K152528 | Attachable Cath Lab Hemostasis Valve | Galt Medical Corp | DTL | Class II |