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 |
|---|---|---|---|---|---|
| K073131 | Micromri Wrist Coil | Micromri, Inc. | MOS | Class II | |
| K072991 | Patriot Spacers: Colonial Acdf | Globus Medical, Inc. | ODP | Class II | |
| K072970 | Patriot Spacers | Globus Medical, Inc. | MAX | Class II | |
| K072849 | Modification to Thermage Thermacool System | Solta Medical, Inc. | GEI | Class II | |
| K072652 | Enteral Feeding Spike Adapter | Cedic S.r.l. | KNT | Class II | |
| K072219 | Cytophil Tissue Marker | Cytophil, Inc | NEU | Class II | |
| K072124 | Black and Black Electrosurgical Cutting and Coagulation Forceps and Electrodes | Black & Black Surgical, Inc. | GEI | Class II | |
| K071631 | Nicom Electrodes | Cheetah Medical, Inc. | DXG | Class II | |
| K080013 | Registration and Fusion | AGFA Healthcare Corp. | LLZ | Class II | |
| K073662 | Playtex Gentile Glide, Playtex Gentile Glide Multipack Tampons | Playtex Products, Inc. | HIL | Class II | |
| K073412 | Gryphon Br and Healix Br Anchors | DePuy Mitek, Inc. | MAI | Class II | |
| K073395 | Gilb-2, Glass Ionomer Protective Coating | 3M ESPE Dental Products | EMA | Class II | |
| K073114 | Imix Insight X-Ray Systems | Imix Adr Finland Oy | KPR | Class II | |
| K073101 | Auraveneer Cement | Denali Corporation | EMA | Class II | |
| K072978 | Tender Ortho Bond-Ena Bond-Ena Etch | Micerium S.p.A. | DYH | Class II | |
| K072635 | Clinical Electronic Thermometers, Model(s) Mt901, Mt518, Ect-1 | Ningbo Huahui Medical Instruments Co., Ltd. | FLL | Class II | |
| K071456 | Arthrex Prostop Plus Arthroereisis Subtalar Implant | Arthrex GmbH | MAI | Class II | |
| K080036 | Portable Ecscope 12I | Dyansys, Inc. | DPS | Class II | |
| K073318 | Bipore Balloon Dilation Catheter | Bipore, Inc. | LIT | Class II | |
| K073206 | Needle-Trap/needle Safety Label | Schreiner Medipharm | MEG | Class II | |
| K072662 | Cheetah Reliant, Cheetah Active | Cheetah Medical, Inc. | DSB | Class II | |
| K072190 | Ortho-Wrap Bioresorbable Sheet | Mast Biosurgery | FTL | Class II | |
| K071420 | Chameleon Fixation System | SPINEFRONTIER, Inc. dba LESspine Innovations | MRW | Unclassified | |
| K063091 | Pivit Crm (Tyrx Antimicrobial Pacemaker Pouch), Model Cmrm-0601 | Tyrx Pharma, Inc. | FTL | Class II | |
| K073451 | Pressure Injectable Picc | Arrow International LLC (subsidiary of Teleflex Incorporated) | LJS | Class II | |
| K073090 | Recovery G2 Filter System - Femoral Delivery Kit, Model RF-310F; Jugular/subclavain Delivery Kit, Model RF-320J | C.R. Bard Inc | DTK | Class II | |
| K072149 | Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01 | Phadia AB | LLL | Class II | |
| K073513 | Merits E700 Porce Lift | Merits Health Products, Inc. | ING | Class II | |
| K073512 | Start Junior | Otto Bock Healthcare LP | IOR | Class I | |
| K073473 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/x Ivus Imaging Catheter, Model 85700 | Volcano Corporation | OBJ | Class II | |
| K073433 | Bd Phoenix Automated Microbiology System-Piperacillin (Gn) -128 Ug/ml | Becton Dickinson & Co | LON | Class II | |
| K073431 | Forsure Ifob Duel Sample Fecal Occult Blood Test Device (for Professional and Home Use); (for Professional); (for Home T | Tianjin New Bay Bioresearch Co., Ltd. | KHE | Class II | |
| K072917 | Jjg Evolution Orthodontic Implant System | Odontit SA | DZE | Class II | |
| K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | HRX | Class II | |
| K072870 | Microwave Tissue Coagulation System (Mtcs) | Foundry Newco X, Inc. | NEY | Class II | |
| K072869 | Pointcare Now System | Pointcare Technologies, Inc. | GKZ | Class II | |
| K072825 | Fingertip Pulse Oximeter, Model Md300i | Beijing Choice Electronic Technololgy Co., Ltd. | DQA | Class II | |
| K071104 | Acute Portable Exchange Deionization (Pedi) System, Central Pedi System, Back-Up Pedi System | Flier'S Quality Water Systems, Inc. | FIP | Class II | |
| K070511 | Richter Male Latex Condom | Richter Rubber Technology Sbn Bhd | HIS | Class II | |
| K073630 | Modification to: Bpcard, Model Z-7000-0700 | VectraCor, Inc. | DXN | Class II | |
| K073514 | Trans1 Axial Fixaton System | Trans1 Incorporated | KWQ | Class II | |
| K073491 | EEG-1100A Switch Box | Nihon Kohden America Inc | OLV | Class II | |
| K073462 | Modification to Dash 3000, 4000, 5000 Monitor and Accessories | GE Medical Systems Information Technologies, Inc. | MHX | Class II | |
| K073452 | Modification to: Aragon Surgical Lapcap | Aragon Surgical, Inc. | HIF | Class II | |
| K073289 | Microsheath Xl Catheters | Flowcardia, Inc. | DQY | Class II | |
| K073198 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watchbp Home (Bp3mx1-1) | Microlife Intellectual Property GmbH | DXN | Class II | |
| K073190 | Slit Lamp | Huvitz Co., Ltd. | HJO | Class II | |
| K073142 | Nobelreplace Hexagonal Implant | Nobel Biocare USA LLC | DZE | Class II | |
| K073038 | Carematix Wellness System, Model Cws-5000.1-B | Carematix Inc. | DRG | Class II | |
| K072790 | Confluent Surgical Extended Tip Applicator, Model 70-2008-008 | Confluent Surgical,Inc | FMF | Class II |