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 |
|---|---|---|---|---|---|
| K071079 | Spectra Optia Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200 | Terumo BCT, Ltd | LKN | Unclassified | |
| K071043 | Boston Xo (Hexafocon a), Boston Eo (Enflufocon B) and Boston Es (Enflufocon a) Rigid Gas Permeable Contact Lenses | Bausch & Lomb Incorporated | HQD | Class II | |
| K070999 | Bc (Body Composition Software) | Rjl Systems, Inc. | MNW | Class II | |
| K070987 | Sentinel Lithium Assay | Sentinel CH SpA | NDW | Class II | |
| K070627 | Opaciden Solution | Ciden Technologies, LLC | MED | Class II | |
| K063310 | Truefield Analyzer | Seeing Machines Limited | HPT | Class I | |
| K071959 | Angiodynamics, Inc.nevertouch 600Um Fiber and Venacure Procedure Kit | Boston Scientific Corporation | GEX | Class II | |
| K071949 | Victory, 4 Wheel Scooter / Model, # Sc1740 | Pride Mobility Products Corp | INI | Class II | |
| K071860 | Modification to: Viper Spine System | DePuy Spine, Inc. | NKB | Class II | |
| K071451 | Tattoostar Y | Asclepion Laser Technologies GmbH | GEX | Class II | |
| K071269 | Hemodraw Arterial Blood Sampling System | Abbott Medical | CBT | Class I | |
| K071137 | Sonicator Plus 940, Model Me940 | Mettler Electronics Corp | IMG | Class II | |
| K070928 | Ceramic Ball Heads, 28, 32 and 36 Mm | Plus Orthopedics | LZO | Class II | |
| K070820 | Architect Tacrolimus: Model 1L77 | Fujirebio Diagnostics, Inc. | MLM | Class II | |
| K070625 | Pelvimesh / Hermesh 7 | Marketing Solutions, Inc. | FTL | Class II | |
| K070594 | Palmtop Ventilator, Models Ptv-8, Ptv-10 | Pulmonetic Systems, Inc. | CBK | Class II | |
| K070201 | Bard Intra-Abdominal Pressure Monitoring Device, Model Iap-001 | C.R. Bard Inc | PHU | Unclassified | |
| K071590 | Therma-Cure | Reliance Orthodontic Products, Inc. | DYH | Class II | |
| K071514 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307 | Possis Medical, Inc. | QEZ | Class II | |
| K071498 | Subtalar Implant | Biomet Sports Medicine | HWC | Class II | |
| K071342 | Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041, 106553, 105039 | Possis Medical, Inc. | QEZ | Class II | |
| K071214 | Ats Simulus Adjustable Flexible Annuloplasty Ring | Genesee BioMedical, Inc. | KRH | Class II | |
| K070731 | Pigalileo Total Hip Replacement (Thr) System | Plus Orthopedics | HAW | Class II | |
| K070451 | Able Central Venous Catheter | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | FOZ | Class II | |
| K070148 | Graft Containment Device | NuVasive Inc | KWQ | Class II | |
| K072000 | Aplio Xg Diagnostic Ultrasound System, Model Ssa-790A Version 2.0 | Toshiba America Medical Systems, In.C | IYN | Class II | |
| K071972 | Orthopedic Software for Impax Workstations | AGFA Healthcare Corp. | LLZ | Class II | |
| K071856 | Zimmer M/l Taper Hip Prosthesis with Kinectiv Technology System, Model(s) 7848 Series( Modular Necks), 7713 Series | Zimmer GmbH | KWA | Class III | |
| K071791 | Modification to Cranioplastic, Model 43-1280 | Cerenovus, Inc. | GXP | Class II | |
| K071587 | Ischemia Albumin Cobalt Binding Test (Acb Test) Assay | Inverness Medical Innovations, Inc. | JJX | Class I | |
| K071571 | Surgiquest Airseal Optical Trocar & Cannula System | Surgiquest, Inc. | GCJ | Class II | |
| K071212 | Esprit Ventilator Speaking Mode Option, Model V1000 | Respironics, Inc. | CBK | Class II | |
| K071211 | Cobas C 111 Analyzer | Roche Diagnostics GmbH | CIT | Class II | |
| K071208 | Master Guard Nitrile Blue Powder Free Examination Gloves | High Momentum Sdn Bhd | LZA | Class I | |
| K071201 | Zeo Ce Light & Zeo Quick Porcelain | Xpdent Corp | EIH | Class II | |
| K071186 | Modification to: Ambu Neuroline Concentric Needle Electrode | Ambu A/S | IKT | Class II | |
| K071123 | Disposable Powder Free Vinyl Exam Glove, Yellow Color | Xuzhou Full Sun Medical Products Ltd. | LYZ | Class I | |
| K071105 | Osteomed Calcaneal Plate and Screw Fixation System | Osteomed | HRS | Class II | |
| K071031 | Vu E*pod Vertebral Body Replacement | Theken Companies LLC | MQP | Class II | |
| K070929 | Acon U120 Urine Analyzer, Model U111-101 | Acon Laboratories, Inc. | KQO | Class I | |
| K070515 | A-View Basic and Plus | Cordatec N.V. | ITX | Class II | |
| K070406 | Endodrape | Vortek Surgical, LLC | KKX | Class II | |
| K070358 | Maxinsight | Eemagine Medical Imaging Solutions GmbH | OLX | Class II | |
| K070062 | Coproset Salmonella and Shigella, Uriset Preservative Tubes and Swab Set General Use | Diesse Diagnostica Senese S.P.A | LIO | Class I | |
| K063527 | Mbcp+ | Biomatlante | MQV | Class II | |
| K062436 | Sis Sinus Implant Stabilizer | Mondeal Medical Systems GmbH | JEY | Class II | |
| K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K071821 | Coils, Models Mcf-B65, Mcf-75, Mcf-125 and Cool-B65 | Tonica Elektronik a/S | GWF | Class II | |
| K071444 | Mechanical Wheelchair - L-Frame Series | Colours 'N Motion | IOR | Class I | |
| K071282 | Model Segaego 4D Scooter | Dalton Medical Corp. | INI | Class II |