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 |
|---|---|---|---|---|---|
| K090356 | Emergency Portable Ventilator, Model Epv200 | Allied Medical LLC | BTL | Class II | |
| K090317 | Babi*plus Bubble Pap Valve | A Plus Medical | BYE | Class II | |
| K090160 | Suprathel Wound and Burn Dressing | Polymedics Innovations | QSZ | Unclassified | |
| K090094 | Zeltiq System | Zeltiq Aesthetics Inc | GEX | Class II | |
| K083921 | Synergeyes Sig (Petrafocon a Hem-Larafilcon a) Hybrid Contact Lens | Synergeyes, Inc. | HQD | Class II | |
| K083850 | Euroimmun Anca Ifa Europlus Granulocyte Biochip Mosaic Test Systems | Euroimmun US Inc. | MOB | Class II | |
| K081755 | Fusion Medical Sti | John Riccio | HWC | Class II | |
| K091070 | Manoscan Motility with Impedance Visualization System | Sierra Scientific Instruments, Inc. | FFX | Class II | |
| K090899 | Depuy Spine Lateral System | DePuy Spine, Inc. | MAX | Class II | |
| K090793 | Bongros Ha | Bioalpha, Inc. | LYC | Class II | |
| K090425 | Guided Lateral Interbody Fusion (Glif) System | Alphatec Spine, Inc. | MAX | Class II | |
| K090197 | Eg-3870Utk | PENTAX of America, Inc. | ODG | Class II | |
| K090196 | Eg-3670Urk | PENTAX of America, Inc. | ODG | Class II | |
| K090005 | Branemark Integration Biohelix Implants | Branemark Integration AB | DZE | Class II | |
| K091215 | Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent Surgical Instrument | Power Medical Interventions, Inc. | GDW | Class II | |
| K091206 | Sleuth at Implantable Cardiac Monitoring System-6 and 8Cm Antenna, Personal Diagnostic Manager(pdm) Accessory Kit, Model | Transoma Medical | MXC | Class II | |
| K091194 | Algiseal Pad | Evolution Medical Technologies, LLC | QSY | Unclassified | |
| K091154 | Utrecht Interstitial Fletcher Ct/mr Applicator Set, Model 110.270, Interstitial Ring Ct/mr Applicator Set,model 110.330, | Nucletron BV | JAQ | Class II | |
| K091009 | My Labs25 Gold/mylab30 Gold Cardiovascular Model 7340, My Lab70/my Lab70xvision/mylab60, Model 6150 | Esaote S.p.A. | IYN | Class II | |
| K090800 | Vs-100 Illumination and Imaging System | Schoelly Imaging, Inc. | FET | Class II | |
| K090749 | Roograph Evo, Model 9307Xy11z1, Rotograph Evo D, Model 9307Xy1191 | Villa Sistemi Medicali S.p.A. | EHD | Class II | |
| K090672 | Agfa Computed Radiography Systems with Nx Workstations | AGFA Healthcare Corp. | MQB | Class II | |
| K090520 | Stretch Vinyl Examination Glove, Powder Free (Yellow/white) | Shandong Huayue Glove Co., Ltd. | LYZ | Class I | |
| K090062 | Wv1417a Digital X-Ray Direct Imaging Flat Panel Detector System | Direct Digital Imaging Technology (Beijing), Inc. | MQB | Class II | |
| K083507 | Battery Pack for Mcv100 and Mcv200 Emergency Ventilators | Allied Medical LLC | BTL | Class II | |
| K083455 | Lipokit with Disposable 50Cc Aft Syringe, Model Zlk-100 | Medi-Khan USA, Inc. | MUU | Class II | |
| K083327 | Syngocirculation Dynamicpet, Version 1.0 | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K081823 | Masterscreen Paed - Baby Body | Viasys Healthcare GmbH | CCM | Class II | |
| K091295 | Aplio Xg Diagnostic Ultrasound System Model Ssa-790A Version 4.0 | Toshiba America Medical Systems, In.C | ITX | Class II | |
| K091286 | Syngo US Workplace | Siemens Medical Solutions USA, Inc. | LLZ | Class II | |
| K091119 | Modification to the Crosser System | Flowcardia, Inc. | PDU | Class II | |
| K091112 | Respironics Sleepeasy CPAP System | Respironics, Inc. | BZD | Class II | |
| K090966 | Amigo Category III Full-Sized Regular Duty 3 Wheel (310000) and Amigo Category V Heavy Duty 3 Wheel (650000) | Svrc Industries, Inc. | INI | Class II | |
| K090834 | Epicardia 5000 | Medicomp, Inc. | DSI | Class II | |
| K090390 | Cd Horizon Spinal System | Medtronic Sofamor Danek | NKB | Class II | |
| K090270 | Backstop Catheter, Model 60-0000-3100 | Pluromed, Inc. | KOD | Class II | |
| K090265 | Bravo Autoclave, Models 17, 17V and 21V | Scican Ltd. | FLE | Class II | |
| K090234 | Spectra System Dental Implants 2008 | Implant Direct, LLC | DZE | Class II | |
| K090066 | Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling Claim of 50 Micrograms per Dm2 of Glove | Wear Safe (Malaysia) Sdn Bhd | KGO | Class I | |
| K083851 | Inviroblunt Cannula with and without Ez Wings, Models 120522 and 120022 | Inviro Medical Devices, Inc. | LHI | Class II | |
| K083545 | Ziehm Vision Rfd | Ziehm Imaging GmbH | OWB | Class II | |
| K083253 | Lotus II Pulsed Er: Yag Laser System | Laseroptek | GEX | Class II | |
| K082403 | Medos Hilite Oxygenator, Model 7000 & 7000 Lt | Gish Biomedical, Inc. | DTZ | Class II | |
| K081591 | Neucodia | Verisci Corporation | GWE | Class II | |
| K091073 | Wbr Xpress.cardiac and Xpress3.cardiac Including Attenuation and Scattering Corrections | Ultraspect, Ltd. | KPS | Class II | |
| K090489 | Abthera Open Abdomen Dressing, Model: M8275026 | KCI USA, Inc. | FTL | Class II | |
| K090470 | Autosuture Protack; Tacker System; Absorbatack Fixation Devices | Medtronic, Inc. | OCW | Class II | |
| K090424 | Dvx Spine System | BK Meditech Co., Ltd. | MNH | Class II | |
| K090413 | A1cnow+ (10 Test Kit, Professional Use) Model 3024, A1cnow+(20 Test Kit, Professional Use) Model 3021, A1cnow Self Chec | Medrad, Inc. | LCP | Class II | |
| K090113 | Breas Vivo 40 System | Breas Medical AB | MNT | Class II |