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 |
|---|---|---|---|---|---|
| K004036 | Sheer Thin Aromas Green Latex Condom | Eagle Twe, Inc. | HIS | Class II | |
| K004028 | Arglaes-Ab Antimicrobial Barrier Powder Dressing | Maersk Medical A/S | FRO | Unclassified | |
| K004021 | F1 Diode Laser System | Opus Medical, Inc. | GEX | Class II | |
| K004016 | Sheer Thin Aromas Blue Latex Condom | Eagle Twe, Inc. | HIS | Class II | |
| K004011 | Impra Carboflo Vascular Graft, Impra Carboflo Vascular Grafts for a-V Access | Impra, Inc. | DSY | Class II | |
| K003723 | 3M Littmann | 3M Company | DQD | Class II | |
| K003113 | Ksea Scb-Rui Sco | Karl Storz Endoscopy-America, Inc. | FET | Class II | |
| K002869 | Localisa Cardiac Navigation System | Medtronic Navigation, Inc | DQK | Class II | |
| K010403 | Prestige Iq Blood Glucose Test System, Model 507400, 537600, 550600, 561700, 563700 | Home Diagnostics, Inc. | NBW | Class II | |
| K010277 | Ams Fascial-Anchoring System | American Medical Systems, Inc. | NEH | Class II | |
| K010256 | Ultravue/p 2000T, Ultravue/c 2000T (Hioxifilcon B) Soft (Multifocal Toric) Daily Wear Contact Lens (Clear & Blue Visibil | Opti-Centre Laboratories | LPL | Class II | |
| K010090 | Xltek Evoked Potential Headbox, Model Ep-4-Rp (Proposed) | Excel Tech., Ltd. | GWF | Class II | |
| K010089 | Real Patient Wireless Ambulatory EEG, Model Ex-Amb-Wireless-Rp (Proposed) | Excel Tech., Ltd. | GWQ | Class II | |
| K010088 | Real Patient Ambulatory EEG, Model Ex-Amb-Rp (Proposed) | Excel Tech., Ltd. | GWQ | Class II | |
| K010013 | Ligasure Laparoscopic Sealer Divider Model Ls1100 | Medtronic, Inc. | GEI | Class II | |
| K004006 | Selecta 7000 Frequency Doubled, Q-Switched Nd:yag Ophthalmic Laser | Lumenis Ltd | GEX | Class II | |
| K003993 | Dornier Medilas D Skinpulse Laser System (Skinpulse) | Dornier Surgical Products, Inc. | GEX | Class II | |
| K003345 | Aosept Plus Cleaning and Disinfecting Solution | Alcon Laboratories | LPN | Class II | |
| K002829 | Dj Orthopedics Femoral Anchor | DJ Orthopedics, LLC | MBI | Class II | |
| K001734 | Fogarty Valvulotome, Model 700091 | Edwards Lifesciences LLC | MGZ | Class II | |
| K000655 | Ppcid- Pneumatic Peripheral Circulation Improvement (Footrest) Device | Ahava Stein | IRP | Class II | |
| K010718 | Flexi-Site Sp02 Ear Sensor | Epic Medical Equipment Services, Inc. | DPZ | Class II | |
| K010636 | Focus Dailies (Nelfilcon a) One-Day Soft Contact Lenses, Focus Dailies Progressives (Nelfilcon a) One-Day Soft Contact | Alcon Laboratories | MVN | Class II | |
| K010598 | Synovialscopics, Synovial Fluid Control | Quantimetrix Corp. | JPK | Class II | |
| K010389 | Chad Therapeutics Oxymatic Model 401 and Oxymatic Model 411 | Chad Therapeutics, Inc. | NFB | Class II | |
| K003835 | Jas Magnesium Reagent | JAS Diagnostics/Drew Scientific | JGJ | Class I | |
| K003752 | Biosafe Capillary Blood Transport System for Testing Thyroid Stimulating Hormone (Tsh) | Biosafe Laboratories, Inc. | JLW | Class II | |
| K000977 | Components for Cardiovascular Procedure Kit - Heat Exchanger Coils | Olson Medical Sales, Inc. | DTR | Class II | |
| K010515 | Modification to Synergy Spinal System | Interpore Cross Intl. | KWP | Class II | |
| K010497 | Silverspeed Hydrophilic Guidewire, Models 103-0601-300 and 103-0602-300 | Medtronic, Inc. | DQX | Class II | |
| K010364 | Mcc-Miv One 2 One Software | Invacare GmbH | ITI | Class II | |
| K010158 | Thrombomax-Hs with Calcium, Model T6540 | Sigma Diagnostics, Inc. | GGO | Class II | |
| K010037 | Daum Double-Shoot Bisopsy Gun | Daum Corp. | KNW | Class II | |
| K003929 | Niroyal Biliary Premounted Stent System | Boston Scientific Corporation | FGE | Class II | |
| K003897 | Endius Bipolar Sheath | Endius, Inc. | GEI | Class II | |
| K003404 | Suprasperm System | Medicult A/S | MQL | Class II | |
| K003163 | Synvitro Flush | Medicult A/S | MQL | Class II | |
| K003156 | Blastassist System | Medicult A/S | MQL | Class II | |
| K002286 | Ldob Occlusion Balloon Catheter | Cook Inc. | MJN | Class II | |
| K002154 | K.e.a.t. | Emd Electronic Medical Devices, Corp. | KPI | Class II | |
| K000724 | Medica Hp 300 Hemofiltration Pump, Model 300 | Medica Corp. | KDI | Class II | |
| K010686 | Ktj-20C Blood Pressure Cuff, Model Ktj-20C | Golden Horse Medical Equipment (Wuxi) Co., Ltd. | DXQ | Class II | |
| K010222 | Ohmeda Medical Giraffe Incubator | GE Healthcare | FMZ | Class II | |
| K010058 | Image IV Dicom Image Archival Pacs Network | Invivo Corporation | LLZ | Class II | |
| K003971 | Axya Medical, Inc. Model 1000 Axyaloop Bone Anchor | TORNIER Inc. | MBI | Class II | |
| K003960 | Dj Orthopedics Tibial Anchor | DJ Orthopedics, LLC | MBI | Class II | |
| K003951 | Pectofix Sternal Repair Wire | Pectofix, Inc. | JDQ | Class II | |
| K003939 | Venture Home Fill II, Model Ioh 200 | Invacare GmbH | CAW | Class II | |
| K003553 | 0.9% Sodium Chloride Injection, Usp Bd Pre-Filled Flush Syringe | BD Becton Dickinson Vacutainer Systems Preanalytic | FOZ | Class II | |
| K002789 | Medeview System | Medeview.Com | LLZ | Class II |