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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K231240 | MaxTack™ Motorized Fixation Device | Medtronic, Inc. | OCW | Class II | |
| K231146 | AliTight | Alic Iotech, LLC | GEI | Class II | |
| K231141 | STarFix Designer Software C0265 | FHC, Inc. | QRI | Class II | |
| K230890 | ISE Electrodes | Randox Laboratories, Limited | CEM | Class II | |
| K230661 | Zeta Cranial Navigation System | Zeta Surgical Inc. | HAW | Class II | |
| K230535 | KARL STORZ Urological Laser Accessories | Karl Storz SE & Co. KG | GEX | Class II | |
| K230372 | VitreJect Syringe | Ocuject, LLC | QLY | Class II | |
| K230310 | STAT Medical Device Lancing System | Stat Medical Devices, Inc. | QRK | Class II | |
| K223848 | Intrisound™ Tuned Lumen® 155 Hearing Aids | Tuned, Ltd. | QUH | Class II | |
| K223827 | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 | FUJIFILM Corporation | FDF | Class II | |
| K223621 | DeepXray | Alpha Intelligence Manifolds, Inc. | QIH | Class II | |
| K222921 | Minuteful-kidney test | Healthy.io Ltd. | JIR | Class I | |
| K213510 | Immulite/immulite 1000 Om-Ma, Immulite 2000 Om-Ma | Siemens Healthcare Diagnostics Products Limited | LTK | Class II | |
| K232443 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | Argon Medical Devices, Inc | MMX | Class II | |
| K232389 | Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue | Masimo Corporation | DQA | Class II | |
| K231999 | Steriking® LT-Blueline Pouches with Tyvek® | Wipak Oy | FRG | Class II | |
| K231996 | Steriking® LT-Blueline Pouches with Tyvek® | Wipak Oy | FRG | Class II | |
| K231828 | Pounce™ Sheath | Surmodics, Inc. | DYB | Class II | |
| K231800 | IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 | Shenzhen Qianyu Technology Co., Ltd. | OHT | Class II | |
| K231687 | Gradual Dental Zirconia Blank | Liaoning Upcera Co.,Ltd | EIH | Class II | |
| K231542 | Digital Blood Pressure Monitor WBP Series | Weony (Shenzhen) Technology Co., Ltd. | DXN | Class II | |
| K231207 | CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | Biosense Webster Inc | DQK | Class II | |
| K230649 | Arm Blood Pressure Monitor | Alicn Medical Shenzhen, Inc | DXN | Class II | |
| K230644 | Signum opaque F | Kulzer GmbH | EBF | Class II | |
| K230049 | SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT | TTK Healthcare Limited | HIS | Class II | |
| K222823 | AeroDVx Arm System | Sun-Scientific Inc. | JOW | Class II | |
| K221743 | Radio Frequency Plasma Surgical Systems; Radio Frequency Plasma Surgical Electrodes | Jiangsu Bonss Medical Technology Co., Ltd. | GEI | Class II | |
| K232482 | MAGNETOM Viato.Mobile | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K231717 | IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 | Foshan Jindi Electric Appliance Co.,Ltd | OHT | Class II | |
| K230824 | IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) | Art Optical Contact Lens, Inc. | LPL | Class II | |
| K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible | Micro-Tech (Nanjing) Co., Ltd. | FGE | Class II | |
| K230024 | Hi-Emt Magshape | Beijing Sano Laser S&T Development Co, Ltd. | NGX | Class II | |
| K223575 | Phoenix ICON, Phoenix ICON GO | Neolight, LLC | HKI | Class II | |
| DEN230006 | esolution | S4 Medical Corp | QXU | Class II | |
| K232691 | Polibond | Zirkonzahn SRL | EBI | Class II | |
| K232361 | Promaxo MRI System II | Promaxo, LLC | LNH | Class II | |
| K231819 | Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw | Innovate Orthopaedics Ltd. | HWC | Class II | |
| K230743 | ICHOR 14F Embolectomy System | Ichor | QEW | Class II | |
| K223684 | F&P 820 Humidification System | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K221869 | BCR-ABL1 (p210) % IS Kit (Digital PCR Method) | Suzhou Sniper Medical Technologies Co., Ltd | OYX | Class II | |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | Ortho-Clinical Diagnostics, Inc. | CEW | Class II | |
| K201869 | Ki Power Tilt System | Ki Mobility | ITI | Class II | |
| K200583 | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL | Ki Mobility | IOR | Class I | |
| K232657 | InnerView LC | Perimetrics, Inc | EKX | Class I | |
| K232340 | Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor | Arthrex GmbH | MBI | Class II | |
| K232334 | Deka Simon | El.En S.p.A. | IPF | Class II | |
| K232314 | Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) | FUJIFILM Healthcare Americas Corporation | FDS | Class II | |
| K232068 | HyperLight Portable X-ray Unit | Changzhou Sifary Medical Technology Co., Ltd. | EHD | Class II | |
| K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | MOS | Class II | |
| K232014 | CONDUIT™ ATP Inserters | Enztec Limited | MAX | Class II |