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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K243836 | Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | LCJ | Unclassified | |
| K241641 | Electric Wheelchair (YE200) | Shenzhen Yattll Industry Co., Ltd | ITI | Class II | |
| K243814 | NuVasive Pulse System | Globus Medical, Inc. | OLO | Class II | |
| K243811 | Erchonia Zerona® VZ8 | Erchonia Corporation | OLI | Class II | |
| K243806 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co.,Ltd. | FMI | Class II | |
| K243492 | Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co.,Ltd | OHS | Class II | |
| K243477 | Universal Tendon Spacer | Askorn Medical | HXA | Class II | |
| K243195 | Arthrex SS VAL and VAL KreuLock™ Compression Screw System | Arthrex GmbH | HWC | Class II | |
| K243111 | Bowhead ERA Wheelchairs | Bowhead Design Corp | IOR | Class I | |
| K242901 | ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) | Tools for Surgery, LLC | KNT | Class II | |
| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | PCH | Class II | |
| K242767 | Safecare Urinary Tract Infection Test | Safecare Biotech(hangzhou)co.,Ltd | JMT | Class I | |
| K242528 | Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) | Shenzhen Ruiankang Technology Co., Ltd. | DXN | Class II | |
| K242366 | OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment | Overfibers S.R.L | EMA | Class II | |
| K242228 | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) | Triopsy Medical, Inc. | KNW | Class II | |
| K242071 | Xpert Xpress CoV-2/Flu/RSV plus | Cepheid | QOF | Class II | |
| K241891 | ScreenDx | Imvaria | QWO | Class II | |
| K241781 | Solo Pace Control | Solo Pace Inc | DTE | Class II | |
| K241764 | Mould Probe MR Safe | Varian Medical Systems, Inc. | JAQ | Class II | |
| K241676 | TriVerity | Inflammatix | PRE | Class II | |
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) | Carl Zeiss Meditec Inc | JAD | Class II | |
| K241064 | Unscented Tampon | Shandong Intco Hygiene Products Co., Ltd. | HEB | Class II | |
| K241009 | PeriCALM Patterns 3.0 | Perigen, Inc. | HGM | Class II | |
| K240267 | Klaxon (Twist); Klaxon (Twist R) | Klaxon-Mobility GmbH | ITI | Class II | |
| K242805 | Dental Cone-beam Computed Tomography (FinScan F350) | Changzhou Finno Medical Technology Co., Ltd. | OAS | Class II | |
| K241273 | FullFocus | Paige.ai, Inc | QKQ | Class II | |
| K243818 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Hartalega NGC Sdn Bhd | LZA | Class I | |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&V | Qiagen | PCH | Class II | |
| K243644 | Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) | Ceragem Co., Ltd. | JFB | Class II | |
| K242842 | ANNE View, Central Hub | Sibel Health Inc. | MSX | Class II | |
| K242741 | ACE Cannula | ACE MEDICAL INDUSTRy CO., Ltd. | FMI | Class II | |
| K242661 | TRI-matrix® X-Force Implants | Tri Dental Implants Int. AG | DZE | Class II | |
| K242290 | DormoTech NLab | Dormotech Medical Inc. | MNR | Class II | |
| K242043 | Sperm Freezing Medium | Gimbo Medical Technology Shenzhen Co., Ltd. | MQL | Class II | |
| K241806 | Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel | Life Technologies Corporation | QOF | Class II | |
| K241489 | ReminGel | Inter-Med, Inc. | LBH | Class II | |
| K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) | Hiossen, Inc. | NHA | Class II | |
| K240590 | Electrical Scooter, WT-T4SU | Wu's Tech Co., Ltd. | INI | Class II | |
| K243335 | Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation | LNH | Class II | |
| K243259 | MASADA Modular Spinal Fixation System | Astura Medical | NKB | Class II | |
| K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) | OrbusNeich Medical (Shenzhen) Co., Ltd. | DQY | Class II | |
| K242019 | GXR-Series Diagnostic X-Ray System | DRGEM Corporation | KPR | Class II | |
| K241808 | ApolloHipX (THR.SS.0001) | Corin USA | LLZ | Class II | |
| K241456 | GlutenID Celiac Genetic Health Risk Test | Targeted Genomics, LLC | PTA | Class II | |
| K241079 | uCT 780 | Shanghai United Imaging Healthcare Co., Ltd. | JAK | Class II | |
| K243481 | TMINI Miniature Robotic System | Think Surgical Inc. | OLO | Class II | |
| K243466 | Conformity Stem Extension Line, #0 | United Orthopedic Corp. | LZO | Class II | |
| K242760 | WHILL Model R | Whill, Inc. | INI | Class II | |
| K242753 | SD TL Implant System | ARUM DENTISTRY Co., Ltd. | DZE | Class II | |
| K242499 | Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) | Shenzhen Sontu Medical Imaging Equipment Co., Ltd. | KPR | Class II |