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 |
|---|---|---|---|---|---|
| K904440 | Local Plexus Block Anesthesia Catheter Kits | Preferred Medical Products, LLC | CAZ | Class II | |
| K912228 | Mark 5 Robotic Pipettor | Siemens Healthcare Diagnostics Inc. | JQW | Class I | |
| K911546 | Inlay 90 | Metalor Dental USA Corp. | EJT | Class II | |
| K911488 | Laparoscopic Rinsing Container | United States Endoscopy Group, Inc. | GCJ | Class II | |
| K911451 | i.v. Extender Set | Filtertek, Inc. | FPB | Class II | |
| K911416 | Elite System | Gfb Intl. Trading, Inc. | LXJ | Class II | |
| K911277 | Originals | Face 2 Face Corp. | HQY | Class I | |
| K911259 | Hydent | Pascal International, Inc. | EFH | Class I | |
| K911246 | The Mediscus Pedcare Management System-Model 2 | Medical Group | INX | Class II | |
| K911215 | Gesco per-Q-Cath Needle | Gesco Intl., Inc. | LIT | Class II | |
| K911130 | Hemostatic Y Connector | Merit Medical Systems, Inc. | LIT | Class II | |
| K911073 | Probe Refill Kit | Interspec, Inc. | ITX | Class II | |
| K910880 | Comfor-Board | Medway | KMK | Class I | |
| K910733 | Medisystems Anti-Stick Injection Site Needle | Medisystems Corp. | FMI | Class II | |
| K910654 | Cinemeasure (Tm) | Syracuse Research Corp. | IZI | Class II | |
| K910650 | Selector Md (50Kw and 80 Kw) | Hofmann-Nagel Medical Systems, Inc. | IZO | Class I | |
| K910465 | Meliodent, Denture Resin | Kulzer GmbH | EBI | Class II | |
| K910426 | Sdu 500 Diagnostic Ultrasound Instrument | Shimadzu Medical Systems | HEM | Class II | |
| K910360 | Cuttersil Function Activator | Kulzer GmbH | ELW | Class II | |
| K910189 | Perfourm Putty Soft | Kulzer GmbH | ELW | Class II | |
| K910166 | Cuttersil Xl | Kulzer GmbH | ELW | Class II | |
| K910165 | Cuttersil Mucosa | Kulzer GmbH | ELW | Class II | |
| K905818 | Vacuum-Assisted Blood Collection System | Jtl Medical Corp. | DTN | Class II | |
| K905788 | Model M1251a Mon. Full Disclosure Review System | Hewlett-Packard Co. | DXJ | Class II | |
| K905427 | Eagle Vision Freeman Radiopague Punctum Plug | Grace Medical, Inc. | LZU | Unclassified | |
| K905058 | Palavit L | Kulzer GmbH | EBH | Class I | |
| K904928 | Palavit Glc | Kulzer GmbH | EGD | Class I | |
| K904908 | Stereotactic Irradiation System | Northwest Medical Physics Center | IYE | Class II | |
| K904251 | New Triad Vlc Crown & Bridge Provisional Material | Dentifax Intern, Inc. | EBG | Class II | |
| K902422 | Needle, Aspiration & Injection, Disposable | Gainor Medical Europe, Ltd. | FMI | Class II | |
| K902226 | My-O-Matic 5000I | Monad Corp. | GZJ | Class II | |
| K895920 | Vitapatch Pin Protection Device for Percutaneous | Vitaphore Corp. | KGX | Class I | |
| K885158 | Mensor Compliant Keeper | Merrill C. Mensor, Jr., D.D.S. | DZE | Class II | |
| K910989 | Osteonics Ion Implanted Total Knee Femoral Comp | Osteonics Corp. | JWH | Class II | |
| K911581 | Palmaz(tm) Balloon-Expandable Stent, Modification | Johnson & Johnson Interventional Systems | FGE | Class II | |
| K911041 | Invotec X-Ray Cassette Equipment Drape | Invotec International, Inc. | IXA | Class II | |
| K910284 | Condoms (Rubber Contraceptives) | Suretex, Ltd. | HIS | Class II | |
| K905570 | Electro-Nerve Stimulator TENS Model Biomed 2000/A | BioMedical Life Systems Inc. | GZJ | Class II | |
| K905553 | Lithotriptor System Model 27080 | Karl Storz GmbH & Co. (Kst) | FFK | Class II | |
| K905377 | Electro-Nerve Stimulator TENS Model Systems 2000/A | BioMedical Life Systems Inc. | GZJ | Class II | |
| K905230 | Electro-Neve Stimulator TENS Model Biomed Plus/a | BioMedical Life Systems Inc. | GZJ | Class II | |
| K905219 | 4' Low Volume IV Extension Set | Marquette Medical, Inc. | FPA | Class II | |
| K905218 | 4 Low Volume IV Extension Set with Slide Clamp | Marquette Medical, Inc. | FPA | Class II | |
| K904388 | Pointer F-3 TENS | Oms Medical Supplies, Inc. | GZJ | Class II | |
| K904269 | Neurosearch-24 or Nrs-24 | Lexicor Medical Technology, Inc. | GWQ | Class II | |
| K912038 | Dash Medical Gloves | Safehealth Labs | LYY | Class I | |
| K911840 | Interflo Medical Model Pa3-H Cco/pac Catheter | Intec Medical, Inc. | DYG | Class II | |
| K911769 | Rateminder(tm) V Infusion Pump, Modification | Critikon Company, LLC | FRN | Class II | |
| K911725 | Aca(r) Urine Phencyclidine (U Pcp) Screen Method | E.I. Dupont de Nemours & Co., Inc. | LCM | Unclassified | |
| K911415 | Trumpet Valve | B. Braun of America, Inc. | FMG | Class II |