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 |
|---|---|---|---|---|---|
| K052877 | Powder Free Nitrile Blue Textured Examination Glove | Syntex Healthcare Products Co., Ltd. | LZA | Class I | |
| K052709 | Powder Free Latex Examination Gloves, Sizes Small, Medium, Large, X-Large | Pt.Shamrock Manufacturing Corp. | LYY | Class I | |
| K052698 | Modification to: Aurora | Aurora Imaging Technology, Inc. | LNH | Class II | |
| K052595 | Crc 15Ultra | Mirion Technologies (Capintec), Inc. | JAQ | Class II | |
| K052545 | Infinitt G3 Pacs | Infinitt Co., Ltd. | LLZ | Class II | |
| K051647 | Fortaderm Antimicrobial Wound Dressing | Organogenesis, Inc. | FRO | Unclassified | |
| K051082 | Medtrade Products Skin Protective Barrier Wipe (Sterile and Preserved) | Medtrade Products Ltd. | KMF | Class I | |
| K042691 | Vertefix Vertebroplasty Procedure Set | Cook Inc. | NDN | Class II | |
| K053030 | J. Morita Az Ultrasonic System | J. Morita USA, Inc. | ELC | Class II | |
| K052913 | Ignite Bone Void Filler Kit | Wrightmedicaltechnologyinc | MQV | Class II | |
| K052910 | Power Right Angle Linear Cutter Digital Loading Unit with Reloads | Power Medical Interventions, Inc. | GDW | Class II | |
| K052656 | Vitek Gram Positive Susceptibility Daptomycin | bioMerieux, Inc. | LON | Class II | |
| K052638 | Abbott Spine, Inc. Spinnaker System | Spinal Concepts, Inc. | KNW | Class II | |
| K052607 | Arthrex Interference Screw-Rounded Head Screws, Full Threaded Screws, Sheathed Cannulated Interference Screws | Arthrex GmbH | HWC | Class II | |
| K052576 | Sbi Autofix | Small Bone Innovations, Inc. | HWC | Class II | |
| K052437 | Modified Monoderm Monofilament, Synthetic, Absorbable Suture | Surgical Specialties Corp | GAM | Class II | |
| K052406 | Uni-Thread Spinal System | Spine Vision, Inc. | MNI | Class II | |
| K052280 | Filterwire Ez Embolic Protection System | Boston Scientific Corporation | NFA | Class II | |
| K043007 | Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105 | Hyphen Biomed Sasu | JBQ | Class II | |
| K053024 | Syngo Neuro Dsa CT | Siemens Corp. | JAK | Class II | |
| K052932 | Cryptosporidium II | Techlab, Inc. | MHJ | Class II | |
| K052791 | Modification to: Amphirion Deep 0.014 Otw Pta Balloon Catheter | Invatec Innovative Technologies, S.r.l. | DQY | Class II | |
| K052663 | Ino Therapeutics Inoblender, Model 10004 | Mallinckrodt Manufacturing LLC | MRO | Class II | |
| K052650 | Pioneer U601 Series Aspirator | Merits Health Products, Inc. | BTA | Class II | |
| K052505 | Calf Implant, Model Ec17-X | Implantech Associates Inc | MIB | Class II | |
| K052504 | Gluteal Implant, Models Rnd 5-X, Trd 6-X | Implantech Associates Inc | MIB | Class II | |
| K052496 | Primechair | Dalton Medical Corp. | ITI | Class II | |
| K052483 | Synthes (USA) Spherical Washers | Synthes (USA) Products LLC | NDG | Class II | |
| K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | OMP | Class II | |
| K052182 | Shian Jia Meei Two Channel Digital t.e.n.s. | Shian Jia Meei Enterprise Co., Ltd. | GZJ | Class II | |
| K052019 | North Coast Buffered Iontophoresis Electrode | North Coast Medical Inc | EGJ | Class II | |
| K052018 | Miltex Ligating Clip | Miltex, Inc. | FZP | Class II | |
| K051583 | Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models Tms-3020, Tms-3030, Tms- 3040, Tms-3050 | Tiara Medical Systems, Inc. | BZD | Class II | |
| K051312 | Swirlgraft Bypass and Vascular Access Grafts | Veryan Medical Limited | DSY | Class II | |
| K051274 | Invos System | Somanetics Corp. | MUD | Class II | |
| K051205 | Stryker Spine Avs Asl Peek Spacer | Howmedica Osteonics Corp | MQP | Class II | |
| K051061 | Kronus Glutamic Acid Decarboxylase Antibody Kit | Kronus Market Development Associates, Inc. | NWG | Class II | |
| K050883 | Safersleep System | Safer Sleep, LLC | BSZ | Class II | |
| K050407 | Ligafix Resorbable Interference Screw, Models 30 and 60 | Sciences for Bio Materials | HWC | Class II | |
| K043207 | Ozone Generator | GE Infrastructure Water & Process Technologies | NII | Class II | |
| K052736 | Arthrex K-Wire ,Threaded Models Ar-8990 to 899X, Ar-8991T to Ar-899Xt | Arthrex GmbH | HTY | Class II | |
| K052704 | Model Bbd Breast Immobilization and Biopsy Device | Invivo Corporation | MOS | Class II | |
| K052541 | Model HF-50R Computer Controlled X-Ray System | Avant Medical Systems | KPR | Class II | |
| K052533 | Kimba Spinal Implant | Signus Medizintechnik GmbH | MQP | Class II | |
| K052494 | Novabone-Bioactive Synthetic Graft | Novabone Products, LLC | MQV | Class II | |
| K052435 | Pneumrx Family of Biopsy Needles and Kits | Pneumrx, Inc. | KNW | Class II | |
| K052137 | Ascension Muh | Ascension Orthopedics, Inc. | KXE | Class II | |
| K052095 | Modification to: Direct Digitizer Regius Model 190 | Konica Minolta Medical & Graphic, Inc. | MQB | Class II | |
| K051998 | Regius Model 170 Direct Digitizer | Konica Minolta Medical & Graphic, Inc. | MQB | Class II | |
| K051914 | Generos 80, Generos 60 | Berkeley Advanced Biomaterials | MQV | Class II |