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 |
|---|---|---|---|---|---|
| K262769 | Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT) | Orthocon, Inc. | MTJ | Unclassified | |
| K262460 | Rezum System | Boston Scientific | KNS | Class II | |
| K262315 | NeuroBlate System | Monteris Medical | ONO | Class II | |
| K262243 | Profisil Free | Kettenbach GmbH & Co. KG | LBH | Class II | |
| K261800 | Helo Max Thrombectomy System (HEL2090) | Endovascular Engineering | QEW | Class II | |
| K261647 | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | HRS | Class II | |
| K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) | Philips Consumer Lifestyle B.V. | HGX | Class II | |
| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 | Filmecc Co., Ltd. | DQX | Class II | |
| K260503 | Triton 1 System | Neptune Medical, Inc. | FDF | Class II | |
| K254035 | Mayumi™ Thrombectomy System | MicroVention, Inc., d/b/a Terumo Neuro | QEZ | Class II | |
| K254000 | Happy Health Blood Pressure Monitor | Happy Health, Inc. | DXN | Class II | |
| K253989 | HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) | Maxigen Biotech, Inc. | NUC | Class II | |
| K253673 | M•care System (MW-20) | Marani Health, Inc. | LQK | Class II | |
| K251794 | Tenax® Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | BTR | Class II | |
| DEN250044 | STEMI AI ECG Model | Powerful Medical, Inc. | SHS | ||
| K262809 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | MBI | Class II | |
| K262420 | Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) | Serpex Medical | GEH | Class II | |
| K262364 | Ellian Enigma RF Device | Ellian Corp | GEI | Class II | |
| K262153 | Pivot Insulin Delivery System | Modular Medical, Inc. | LZG | Class II | |
| K261749 | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Cardinalhealth | LZA | Class I | |
| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | GEX | Class II | |
| K261313 | Vivid Explorer/Vivid Advanced/Vivid Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | IYN | Class II | |
| K261311 | Hyalomatrix | Anika Therapeutics, Inc. | QSZ | Unclassified | |
| K260432 | Ruby Intravascular Catheter | Venocare, Inc. | FOZ | Class II | |
| K254198 | Trexo Theo | Trexo Robotics, Inc. | PHL | Class II | |
| K254090 | I-View® | Hologic, Inc. | MUE | Class II | |
| K254026 | 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) | Flexicare Medical Limited. | EOQ | Class II | |
| K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | LZO | Class II | |
| K253065 | Aevumed SUPERCYNCH™ Button System | Aevumed, Inc. | MBI | Class II | |
| K262783 | RadiForce MX247W | Eizo Corporation | PGY | Class II | |
| K262774 | Wearable breast pump (Model: XN/MD-2249BS, ZFHF) | Guangdong Horigen Mother & Baby Products Co., Ltd. | HGX | Class II | |
| K262451 | Arthrex DynaNite Staples | Arthrex, Inc. | JDR | Class II | |
| K262269 | CO2 Laser System (MBT- CO2 Laser) | Beijing Mega Beauty Technology Co., Ltd. | GEX | Class II | |
| K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) | PRIMED Medical Products, Inc. | QSO | Class II | |
| K260884 | UNIDRIVE Select System | Karl Storz SE & CO. KG | GCJ | Class II | |
| K260758 | MAGNETOM Free.Max; MAGNETOM Free.Star | Siemens Shenzhen Magnetic Resonance , Ltd. | LNH | Class II | |
| K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M | GE Healthcare Finland Oy | MHX | Class II | |
| K260613 | AMI™ Plasma Cartridge, AMI™ | Sequitur Health Corp. | JID | Class I | |
| K253961 | SK Knee System | Just Medical Devices (Tianjin) Co., Ltd. | JWH | Class II | |
| K262788 | Nova HD+ | Aura Wellness, LLC | SGT | Class II | |
| K262747 | ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | OCC | Class II | |
| K262658 | Automatic Digital Blood Pressure monitor (LD-526) | Honsun (Nantong) Co., Ltd. | DXN | Class II | |
| K261718 | EZFluence (RADEZ V2) | Radformation, Inc. | IYE | Class II | |
| K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | Guilin Kevin Peter Technology Co., Ltd. | EBF | Class II | |
| K261403 | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter | Global Life Sciences Solutions USA, LLC | FPB | Class II | |
| K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) | Kam Yuen Plastic Products , Ltd. | OHS | Class II | |
| K260488 | MULTIX Impact; MULTIX Impact C | Siemens Medical Solutions USA, Inc. | KPR | Class II | |
| K260387 | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) | Hironic Co., Ltd. | NFO | Class II | |
| K254217 | Aerloom | Evolym, LLC | JOW | Class II | |
| K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) | Medtronic, Inc. | MXD | Class II |