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 |
|---|---|---|---|---|---|
| K260879 | 4Dm | Invia, Llc | QIH | Class II | |
| K260110 | danumed Extension Set for Gastrostomy Button | Danumed Medizintechnik GmbH | PIF | Class II | |
| K254246 | LT Antibacterial Foam with Silver Dressing | Zhejiang Longterm Medical Technology Co., Ltd. | NAD | Class I | |
| K254111 | Irrigation/Urology Sets | B.Braun Medical, Inc. | LJH | Class II | |
| K254074 | TruPress | Procerus Enterprises | DRS | Class II | |
| K254009 | Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) | Lakong Medical Devices Co., Ltd. | SJH | Class I | |
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot) | Koh Young Technology, Inc. | HAW | Class II | |
| K262542 | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim | Top Glove Sdn. Bhd. | LZA | Class I | |
| K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) | Guangzhou Red Pine Medical Instrument Co., Ltd. | FGB | Class II | |
| K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) | Maxter Healthcare, Inc. | LZA | Class I | |
| K261470 | Qf10 | E.A.M Benelux B.V | NHV | Class II | |
| K260997 | Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01) | Endoclot Plus Co., Ltd. | PLL | Class II | |
| K260652 | ColActive Plus | Covalon Technologies, Ltd. | KGN | Unclassified | |
| K252486 | ChestView US (1.1) | Gleamer | MYN | Class II | |
| K251417 | ReVISION 2 | Argus Cognitive, Inc. | QIH | Class II | |
| K262341 | b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | B-One Ortho, Corp. | JWH | Class II | |
| K262173 | N22 Offset Humeral Head | Shoulder Innovations, Inc. | KWT | Class II | |
| K261987 | Reusable SmartPeg | Osstell AB | EKX | Class I | |
| K261956 | Dental Barriers and Sleeves (AB0006) | ANI Co., Ltd. | PEM | Class II | |
| K261823 | da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. | NAY | Class II | |
| K261715 | Emboliner Embolic Protection System (EPC-03) | Emboline, Inc. | PUM | Class II | |
| K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | MBH | Class II | |
| K260312 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid | Gmp Medicare Sdn. Bhd. | LZA | Class I | |
| K260229 | Electric wheelchair (HC819N, HC830N, HC831N) | Yongkang Hengyi Vehicle Co., Ltd. | ITI | Class II | |
| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H | DRTECH Corporation | KPR | Class II | |
| K260062 | MODI System | DreaMed Diabetes, Ltd. | QRX | Class II | |
| K260053 | Power Wheelchair (OS-R-M01I) | Beijing OrionStar Technology Co., Ltd. | ITI | Class II | |
| K254294 | Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30) | Zhejiang Geyi Medical Instrument Co., Ltd. | HIH | Class II | |
| K253988 | LiteSet Trays | Nobel Biocare AB | KCT | Class II | |
| K261131 | Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.) | Shenzhen Osto Medical Technology Co.,Ltd | NUH | Class II | |
| K260396 | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) | Fidelity BioPharma Co. | OBP | Class II | |
| K261684 | FreezeSpray TA | Cryosurgery, Inc. | MLY | Unclassified | |
| K254135 | LipoSurg ARTIST | Nouvag Ag | QPB | Class II | |
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.m.a.i.o | NKB | Class II | |
| K262292 | Gastric Alimetry | Alimetry , Ltd. | MYE | Class II | |
| K262277 | 70 NeuGlide Catheter | Piraeus Medical, Inc. | QJP | Class II | |
| K262235 | ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM) | Medtronic Xomed, Inc. | PGW | Class II | |
| K262130 | ATTUNE Revision Knee System | Depuy Orthopaedics, Inc. | JWH | Class II | |
| K262060 | 3D-Rd-S | Radiopharmaceutical Imaging & Dosimetry, LLC | LLZ | Class II | |
| K261935 | Surgical and Prosthetic Trays | Dentsply Sirona, Inc. | KCT | Class II | |
| K261057 | ActivaScrew™ Cannulated COM | Bioretec, Ltd. | HWC | Class II | |
| K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) | Sentinel Medical Technologies, | EZL | Class II | |
| K260525 | NextMR Spine | MRI2CT, Inc. | QIH | Class II | |
| K260331 | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) | Siemens Healthcare Diagnostics Products, Ltd. | DHB | Class II | |
| K260035 | Digital Indeflator INFLANTE | UAB Telemedicina | MAV | Class II | |
| K254264 | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | QVF | Class II | |
| K254262 | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA | Ortho Clinical Diagnostics Inc. (QuidelOrtho) | PSZ | Class II | |
| K253909 | NeoPEX™ Pre-Mixed Obturation Paste | NuSmile, Ltd. | KIF | Class II | |
| K253836 | FCT iStream Phase 2 | Fujifilm Corporation | JAK | Class II | |
| K253529 | Peerbridge COR MDx (Cor MDx) | Peerbridge Health, Inc. | MWJ | Class II |