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 |
|---|---|---|---|---|---|
| K150021 | Z5m(t) | Z-Systems AG | DZE | Class II | |
| K143676 | B40i Patient Monitor | GE Healthcare Finland Oy | MHX | Class II | |
| K143532 | Durex Silicone | Reckitt Benckiser LLC | NUC | Class II | |
| K143418 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | EGS | Class I | |
| K143219 | Niro-200Nx | Hamamatsu Photonics K.K. | MUD | Class II | |
| K142813 | Biogensis Implant System-Kisses | Biogenesis Co., Ltd. | DZE | Class II | |
| K142040 | Ocs-B Collagen | Nibec Co., Ltd. | NPM | Class II | |
| K141970 | Digitek Titanium Abutment | Digitek Dental Solutions Limited | NHA | Class II | |
| K151889 | Infinity ERCP Sampling Device | United States Endoscopy Group, Inc. | FDX | Class II | |
| K151883 | 5MP Monochrome LCD Monitor, RadiForce GX540 | Eizo Corporation | PGY | Class II | |
| K151298 | Gemini XXP-HP | Dornier Medtech America, Inc. | LNS | Class II | |
| K151199 | SmartDrive Wheelchair Power Assist | Permobil, AB | ITI | Class II | |
| K151177 | XenMatrix AB Surgical Graft | Bard Access Systems, Inc. | PIJ | Class II | |
| K150371 | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH | Diros Technology, Inc. | GXI | Class II | |
| K150316 | Polypectomy Snare | Micro-Tech (Nanjing) Co., Ltd. | FDI | Class II | |
| K142790 | OneTouch Lubricant Gel | Thai Nippon Rubber Industry Co., Ltd. | NUC | Class II | |
| K151829 | Atlas SPEEDER Header/Neck | Quality Electrodynamics | MOS | Class II | |
| K151808 | 3D/5D Viewer | Samsung Medison Co., Ltd. | LLZ | Class II | |
| K151015 | ECHELON Oval V 5.0 MRI System | FUJIFILM Healthcare Americas Corporation | LNH | Class II | |
| K150505 | Cellfina System | Merz North America, Inc. | OUP | Class II | |
| K150377 | Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor | Sony Electronics Inc. | GCJ | Class II | |
| K150107 | Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter | Medtronic, Inc. | DQY | Class II | |
| K143368 | GenIQ | GE Healthcare | LLZ | Class II | |
| K143278 | LnK Posterior Cervical Fixation System | L&K Biomed Co.,Ltd. | KWP | Class II | |
| K143277 | Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile), | Lifestyle Safety Products (Hui Zhou) Co., Ltd. | LYZ | Class I | |
| K151854 | 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display | D-View Display Technology Co., Ltd. | LLZ | Class II | |
| K151464 | Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | OCC | Class II | |
| K151447 | Axium Detachable Coil System | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | HCG | Class II | |
| K151207 | Proton Immobilization Solution | Orfit Industries NV | IYE | Class II | |
| K151150 | Elements | Pac-Dent International, Inc. | ELW | Class II | |
| K151118 | Smith and Nephew Legion Hinge Knee System | Smith & Nephew, Inc. | KRO | Class II | |
| K151105 | Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa | Smith & Nephew, Inc. | MAI | Class II | |
| K151033 | Philips Self-Adhesive Electrodes | Philips Consumer Lifestyle B.V. | GXY | Class II | |
| K151010 | Piccolo Composite Nailing System | CarboFix Orthopedics Inc. | HSB | Class II | |
| K150861 | QBit Series Diagnostic Ultrasound System | Chison Medical Imaging Co., Ltd. | IYN | Class II | |
| K150759 | Hyper-C Anterior Cervical Plate System | Degen Medical | KWQ | Class II | |
| K150715 | 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors | TORNIER Inc. | MBI | Class II | |
| K150699 | Bard LubriGuard Foley Catheter | C.R. Bard Inc | EZL | Class II | |
| K150394 | Tyber Medical Wedge System | Tyber Medical | PLF | Class II | |
| K150251 | Barrx Anorectal RFA Wand | Medtronic, Inc. | GEI | Class II | |
| K142855 | Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) | Omega Laboratories, Inc. | DKZ | Class II | |
| K142829 | Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer | Cook Incorporated | DYB | Class II | |
| K151760 | Barricade Embolization Coil System | Blockade Medical | HCG | Class II | |
| K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | Class II | |
| K151187 | QuadraSphere Microspheres | Biosphere Medical, S.A. | KRD | Class II | |
| K150924 | A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device | Anchor Innovation Medical (A.I.M.) | GZB | Class II | |
| K150236 | Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) | Thermo Fisher Scientific Oy | JWY | Class II | |
| K150014 | Serenity | Sanuthera, Inc. | KLW | Class II | |
| K143737 | EM25 - glute toning device | Hivox Biotek Inc. | NGX | Class II | |
| K151628 | Medline ENFit Connectors | MEDLINE INDUSTRIES, LP - Northfield | PIO | Class II |