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 |
|---|---|---|---|---|---|
| K061118 | Onetouch Ultramini Blood Glucose Monitoring System | Lifescan, Inc. | NBW | Class II | |
| K061078 | Bright Element Snd Bhd Latex Powder Free Examination Gloves | Bright Element Sdn Bhd | LYY | Class I | |
| K061012 | Axsos Plus Locking Plate System | Howmedica Osteonics Corp | HRS | Class II | |
| K060979 | Xia Titanium and 4.5 Spinal Systems | Howmedica Osteonics Corp | NKB | Class II | |
| K060926 | Tripod | Freedom Designs Inc | IOR | Class I | |
| K060860 | Turkom-Cera | Dental Suppliers of America, Inc. | EIH | Class II | |
| K060827 | Mylab30, 50, 70 and 90 Systems Addition of 3D/4d, Models 7300, 7350, 6150, 6100 | Esaote S.p.A. | IYN | Class II | |
| K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8Mm and 10Mm | Zimmer GmbH | PHX | Class II | |
| K060581 | Depuy Solution System Hip Prosthesis | Depuy Orthopaedics Inc. | LPH | Class II | |
| K060478 | Arthrex Bio-Compression Screw | Arthrex GmbH | HWC | Class II | |
| K060240 | K-Jump Digital Thermometer with Battery-Less Patch, Model Kd-2100 | K-Jump Health Co., Ltd. | FLL | Class II | |
| K060122 | Sleep Splint | Nakagawa Dental Clinic | LRK | Class II | |
| K060063 | Legacy Abutment System | Implant Direct, LLC | NHA | Class II | |
| K053638 | Mani Needle & Suture Pack (Silk) | Mani, Inc. | GAP | Class II | |
| K053637 | Mani Needle & Suture Pack (Nylon) | Mani, Inc. | GAR | Class II | |
| K053552 | Global Fertilization, Embryo Culture and Transfer Media | <Genx> Intl., Inc. | MQL | Class II | |
| K053337 | Dimension Urine Ecstasy Screen Flex Reagent Cartridge, Model Df 109 | Siemens Healthcare Diagnostics Inc. | DKZ | Class II | |
| K053207 | Argus, Model Lcm | Schiller, AG | MHX | Class II | |
| K061260 | Intuitive Surgical Endowrist Pk Dissecting Forceps, Models 400214 & 420214 | Intuitive Surgical, Inc. | NAY | Class II | |
| K061259 | Modification to Arthrocare Perc-D Spinewand | ArthroCare Corporation | GEI | Class II | |
| K061258 | Trabectome High Frequency Generator/lp | Neomedix Corp. | GEI | Class II | |
| K061119 | Enpath Medical Steerable Sheath | Greatbatch Medical | DQY | Class II | |
| K061063 | Modification to: Silverhawk Peripheral Plaque Excision System, Models P4028/fg08300 | Foxhollow Technologies, Inc. | MCW | Class II | |
| K060950 | 3Matic | Materialise N.V. | LLZ | Class II | |
| K060821 | Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact Lenses | Specialeyes LLC | LPL | Class II | |
| K060503 | Dimension Tacr Calibrator, Model Dc107 | Siemens Healthcare Diagnostics Inc. | DLJ | Class II | |
| K060502 | Dimension Tacr Flex Reagent Cartridge, Model Df107 | Siemens Healthcare Diagnostics Inc. | MLM | Class II | |
| K053193 | Pm-8000 Express Patient Monitor, Model Pm-8000 Express | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | MWI | Class II | |
| K061103 | Haemonetics 40U Rbc Filter Bag | Haemonetics Corporation | CAK | Class II | |
| K061064 | Coulter Lin-C Linearity Control, Models 7547065, 723503 | Siemens Healthcare Diagnostics Inc. | JPK | Class II | |
| K061048 | Cobas Integra Glucose Hk Gen. 3 Test System | Roche Diagnostics GmbH | CFR | Class II | |
| K060984 | Xenform Soft Tissue Repair Matrix | Integra LifeSciences Braintree Inc. | FTM | Class II | |
| K060880 | Zimmer Dental One Piece Tapered Abutment, Models Tac1, Tacw1, Ta5c1 | ZimVie US Corp LLC | NHA | Class II | |
| K060829 | Cosmatrix | Integra LifeSciences Braintree Inc. | FTM | Class II | |
| K060801 | Dekna-Lok Model Bp1000v2l | Teleflex Medical | GAM | Class II | |
| K060724 | Powder Free Nitrile Examination Glove (Black and Gray) | Smart Glove Corp. Sdn Bhd | LZA | Class I | |
| K060476 | Lapidus Plate | New Deal, S.A. | HRS | Class II | |
| K060473 | Ttc Plate | New Deal, S.A. | HRS | Class II | |
| K060412 | Active Unicompartmental Knee System | Australian Surgical Design & Manufacture | HRY | Class II | |
| K060409 | Hemohalt Hemostasis Pad | Vanson-Halosource, Inc. | QSY | Unclassified | |
| K060388 | Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment | Airway Management Inc. | LRK | Class II | |
| K060036 | Port-a-Cath, Port-a-Cath II, Proport and P.a.s. Port Implantable Venous Access Systems with Dual Layer Catheter | Abbott Medical | LJT | Class II | |
| K053579 | Columbus Ultra Congruent (Uc) Tibial Insert/gliding Surface | Aesculap Inc | JWH | Class II | |
| K053166 | Sinclair Oral Rinse | Sinclair Pharmaceuticals Ltd | NTO | Class II | |
| K052691 | Suretek Medical Reprocessed Compression Sleeves | Suretek Medical | JOW | Class II | |
| K051073 | Midiview Series of Microendoscopes | Millennium Devices, Inc. | GCJ | Class II | |
| K050032 | Euromed Sureskin III with Silver Wound Dressings | Euromed, Inc. | FRO | Unclassified | |
| K061278 | Optyse Ophthalmoscope | Ophthalmos, Ltd. | HLJ | Class II | |
| K061213 | Sonoace Pico Diagnostic Ultrasound System | Medison Co., Ltd. | IYN | Class II | |
| K061177 | Provide Temporary Cylinder | ZimVie US Corp LLC | NHA | Class II |