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 |
|---|---|---|---|---|---|
| K000474 | View Nt | Electromed Intl., Ltd. | LLZ | Class II | |
| K000455 | Gettig Guard | Gettig Pharmaceutical Instrument Co. | FMI | Class II | |
| K000408 | Lifestyles, Contempo or Private Label Strawberry, Vanilla, or Banana Flavored Condom | Suretex Prophylactics, Ltd. | HIS | Class II | |
| K000340 | Hystalog Hsg Catheter | Rocket Medical | HES | Class II | |
| K000222 | Um-L25 | Union Medical Engeneering Co., Ltd. | GEX | Class II | |
| K000205 | Embryon Single and Double Lumen Needles | Rocket Medical | MQE | Class II | |
| K994308 | Nuvasive Townley Facet Screw | NuVasive Inc | MRW | Unclassified | |
| K001154 | I-Stat Model 200 Portable Clinical Analyzer | I-Stat Corp. | JGS | Class II | |
| K000991 | Modification to Tsrh Spinal System | Medtronic Sofamor Danek | MNI | Class II | |
| K000945 | Para 12 Plus Retics | Streck Laboratories, Inc. | GLQ | Class II | |
| K000876 | Synergy Adjustable Transverse Connector Rod, Synergy Adjustable Transverse Connector Lamp | Interpore Cross Intl. | MNI | Class II | |
| K000874 | Urine Control 1, Cat. No. 903600, Urine Control 2, Cat. No. 904100 | Bio-Rad | JJW | Class I | |
| K000865 | Quik-Cap | Neuroscan | GXY | Class II | |
| K000571 | Ge Logiq 700 | GE Healthcare | IYO | Class II | |
| K000522 | Screeners Barbiturate Test, Drugscreen Dip Barbiturate Test | Drug Detection Devices, Ltd. | DIS | Class II | |
| K000508 | Thermoflex System | Argomed, Inc. | KNS | Class II | |
| K000487 | Medtrade Products Alginate Island | Medtrade Products Ltd. | KGN | Unclassified | |
| K000402 | Screeners Phencyclidine (Pcp) Test, Drugscreen Dip Phencyclidine (Pcp) Test | Drug Detection Devices, Ltd. | LCM | Unclassified | |
| K000400 | Screeners Amphetamine Test, Drugscreen Dip Amphetamine Test | Drug Detection Devices, Ltd. | DKZ | Class II | |
| K000245 | Csm Stretta System | Conway Stuart Medical, Inc. | GEI | Class II | |
| K000163 | Pm 2002 Proline/aec | Planmeca Oy | EHD | Class II | |
| K000106 | Depilase Yaglase Nd:yag Laser System and Accessories | Fotona D.D. | GEX | Class II | |
| K994289 | Suturegroove | Iop, Inc. | MML | Class II | |
| K993677 | Medtronic Clearview Intravascular Arteriotomy Shunt | Medtronic, Inc. | DWF | Class II | |
| K991908 | Idemsa Hemophan Hollow Fiber Dialyzers | Idemsa | FJI | Class II | |
| K991818 | Acryderm Silver Anti-Microbial Wound Dressing, Models 1041, 1042, 1043, 1044, 1045 | Acrymed, Inc. | FRO | Unclassified | |
| K991755 | Medline Tender Wet Wound Dressing | MEDLINE INDUSTRIES, LP - Northfield | MGQ | Unclassified | |
| K990034 | Wilson-Cook Colonic Z-Stent | Med Institute, Inc. | MQR | Class II | |
| K000895 | Stat Profile Phox Plus Analyzer | Nova Biomedical Corporation | JGS | Class II | |
| K000603 | Spife Cholesterol Profile Kit | Helena Laboratories, Corp. | JHO | Class I | |
| K000458 | Urine Benzodiazepines (Benz) Screen Flex Reagent Cartridge, Catalog No. Df 92A | Siemens Healthcare Diagnostics Inc. | JXM | Class II | |
| K000406 | Rhinoscan Model Sre2000/ Sre2100 with Acoustic Rhinometry Module | Rhino Metrics A/S | BXQ | Class II | |
| K000398 | Shield Von Willebrand Factor Activity Elisa, Model Fvwf 200 | Shield Diagnostics, Ltd. | GGP | Class II | |
| K000224 | Fluroperm 60-Ok, Paragon Hds-Ok | Paragon Vision Sciences, Inc. | MUW | Class II | |
| K000137 | Enhanced Compensating Filter | Elekta Limited | IXI | Class II | |
| K000043 | Drg Aurica Elisa Testosterone Kit | Drg Intl., Inc. | CDZ | Class I | |
| K993787 | Appraise-Cardio Sample Collection Kit | Osborn Group, Inc. | JKA | Class II | |
| K993545 | Tenax White Post | Coltene /Whaledent AG | ELR | Class I | |
| K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | MNH | Class II | |
| K993489 | Crystal Custom Tinted Soft Contact Lens | Crystal Reflections, Int., Inc. | LPL | Class II | |
| K993092 | Sonada Ultrasound System | Sonovision Corp. | OXO | Class II | |
| K991519 | Ameriwater Purification System for Hemodialysis | AmeriWater LLC. | FIP | Class II | |
| K001037 | Modification to Ebi Spinelink System | Ebi, LLC | MNI | Class II | |
| K001033 | Agility Steerable Guidewire | Cordis Neurovascular, Inc. | DQX | Class II | |
| K000971 | Profeel Powder Free Nitrile Surgical Glove, Sterile | WRP Asia Pacific Sdn Bhd | KGO | Class I | |
| K000911 | Micrograsp Bipolar Coagulator, Models 90048-90057 | Hysterx, Inc. | GEI | Class II | |
| K000898 | EEG with Video, Model Ex-Nw | Excel Tech., Ltd. | GWQ | Class II | |
| K000864 | Intrastent Doublestrut Xs Stent | Intratherapeutics, Inc. | FGE | Class II | |
| K000826 | Prodigy Lateral View Software | Lunar Corp. | KGI | Class II | |
| K000558 | Synthes (USA) Wrist Fusion Plates (Wfp) | Synthes (USA) Products LLC | LXT | Class II |