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 |
|---|---|---|---|---|---|
| K091258 | Extrafix External Fixation System | Qfx Technologies, Inc. | KTT | Class II | |
| K091235 | Ramp Rsv Assay | Response Biomedical Corp. | GQG | Class I | |
| K091185 | 70530-Bactial/viral Filter, 70531-Hmef, 70536-Bacterial/viral Filter | Hsiner Co., Ltd. | CAH | Class II | |
| K091141 | Therafirm Anti-Embolism Stockings, Therafirm Men's and Women's Trouser Socks | Knit-Rite, Inc. | DWL | Class II | |
| K091110 | Spinal Edge Titan Pedicle Screw System | Spinal Edge, LLC | MNH | Class II | |
| K090937 | E-Statis 40 System | Scican Ltd. | EBW | Class I | |
| K090612 | Benacel | Unicare Biomedical, Inc. | OLR | Unclassified | |
| K090438 | Reusable Envitec Finger Spo2 Sensor-Hp/philips Compatible, Models F-2412, F-2414-15, Reusable Envitec Ear Spo2 Sensor | Envitec-Wismar GmbH | DQA | Class II | |
| K090007 | Jumao Oxygen Concentrator, Model Jm-07000Hi, Jm-07000I, Jm-07000 | Danyang Jumao Healthcare Equipment Co., Ltd. | CAW | Class II | |
| K083461 | Imagine Tc Skin Therapy System | Endymion Medical, Ltd. | GEI | Class II | |
| K083421 | Mr-Touch Option | GE Healthcare | LNH | Class II | |
| K083294 | Verigene Cftr Nucleic Acid Test and Verigene Cftr Polyt Nucleic Acid Test | Luminex Corporation | NUA | Class II | |
| K083105 | Kneehab Xp Conductive Garment, Type 411 | Bio-Medical Research, Ltd. | IPF | Class II | |
| K083074 | Avandx E. Faecalis/oe Pna Fish Culture Identification Kit | Advandx, Inc. | OAH | Class I | |
| K082848 | Nubic and Rabea Devices | Signus Medizintechnik GmbH | ODP | Class II | |
| K081603 | Digital Ballistocardiograph, Model Dgb 300 | Heartforce Medical, Inc. | DXR | Class II | |
| K091894 | Temporary C&b Composite | Voco GmbH | EBG | Class II | |
| K091586 | Vascu-Picc and Midline Catheters, Single, Double and Triple Lumen | Medcomp | LJS | Class II | |
| K091421 | Novapro Vinyl Examination Glove Powder Free (Non-Colored) | Novapro Co. Ltd. | LYZ | Class I | |
| K091300 | Ascent Porcelain Primer, Model 006-00078, 00600079 | Cao Group, Inc. | KLE | Class II | |
| K091028 | Omni 5 Total O2 Delivery System | Respironics, Inc. | CAW | Class II | |
| K090879 | Insuflow Co2ionshield | Lexion Medical, LLC. | FCX | Class II | |
| K090817 | Ionolux | Voco GmbH | EMA | Class II | |
| K090766 | Lifeguard Backtrack B90 Breath Alcohol Tester | Lifeloc Technologies Inc | DJZ | Class I | |
| K090646 | Cardiotech Spirometry System, Model Gt-105 | Chest M.I., Inc. | BZG | Class II | |
| K090245 | Solo Insulin Patch Pump | Medingo, Ltd. | LZG | Class II | |
| K083670 | Universal, Aesthetica, Natea, Natura | Euroteknika | DZE | Class II | |
| K080380 | Sas Influenza a & B Test | SA Scientific, Ltd | PSZ | Class II | |
| K091832 | Endogastric Solutions Stomaphyx System with Serosafuse Fastener | Endogastric Solutions, Inc. | OCW | Class II | |
| K091502 | Nuvasive Spherx II System | NuVasive Inc | NKB | Class II | |
| K091429 | Vinyl Powder Free Examination Glove | Shun da (Xinghua) Co., Ltd. | LYZ | Class I | |
| K091388 | Gcuc-505 | GC America Inc. | EBF | Class II | |
| K091383 | Vinyl Powder Free Examination Glove | Shun Tong Co., Ltd. | LYZ | Class I | |
| K091355 | Deuce Polypectomy Snare, Models 000995, 000996,000997, 000998 | Conmed Endoscopic Technologies, Inc. | FDI | Class II | |
| K091264 | Microscan Dried Gram-Positive Mic/combo Panels, Model B1017 | Siemens Healthcare Diagnostics Inc. | LTT | Class II | |
| K091252 | Implant Center 2 | Satelec | DZI | Class II | |
| K091163 | Pg471w , Pg471/50w, Pg474w, Pg477w, Pg479/32w, Pg479/50w, Pg479/75w Fiab Disposable Electrodes with Cable for Electro-St | Fiab SpA | GXY | Class II | |
| K091058 | Adkins Strut | Biomet Microfixation | HRS | Class II | |
| K090902 | Spider Single Port Surgical Device, Support Arm Accessory, Model 90001, 90002, 90003 | Asensus Surgical, Inc. | GCJ | Class II | |
| K090485 | Coaxial Accordion Ercp Device, Models C0ac19001, Coac20005, Coac22003 | Percutaneous Systems, Incorporated | LQR | Class II | |
| K090406 | Ep15 Software Module, Ep25 Software Module | Interacoustics a/S | EWO | Class II | |
| K090320 | Conquest Spinal System | Life Spine | NKB | Class II | |
| K083761 | Alatech Powder Free Latex Examination Glove | Alatech Healthcare, LLC | LYY | Class I | |
| K083113 | Acticoat Flex 7 Dressing | Smith & Nephew, Inc. | FRO | Unclassified | |
| K082647 | Powdered Vinyl Patient Examination Gloves | Tangshan Dar Plastic & Rubber Products Co., Ltd. | LYZ | Class I | |
| K092081 | Qxlink | Vieworks Co., Ltd. | LLZ | Class II | |
| K091911 | Bolus Compensator | .Decimal, Inc. | IXI | Class II | |
| K091645 | Gold Anchor | Naslund Medical Inc. | IYE | Class II | |
| K091075 | Zeus (Zio ECG Utilization Service) System | iRhythm Technologies, Inc. | DQK | Class II | |
| K090830 | Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip | Abbott Medical | FBK | Class II |