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 |
|---|---|---|---|---|---|
| K211837 | Altus Spine Interbody Standalone Fusion System | Altus Partners | OVD | Class II | |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | Helena Laboratories, Corp. | GKA | Class II | |
| K220871 | Nautilus | Dornier Medtech America, Inc. | JAA | Class II | |
| K220131 | KYPHON VuE Bone Cement | Tecres SpA | NDN | Class II | |
| K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair | Psychemedics Corp. | LCM | Unclassified | |
| K213408 | BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free | Meditech Gloves Sdn Bhd | LZA | Class I | |
| K220946 | SURGIVISIO Device | Ecential Robotics | OWB | Class II | |
| K220797 | FootHold System | Crossroads Extremity Systems LLC | MBI | Class II | |
| K220779 | Xd | Mirada Medical Limited | LLZ | Class II | |
| K220459 | Mako Total Knee Application | Mako Surgical Corp. | OLO | Class II | |
| K220141 | RayStation 11B | RaySearch Laboratories AB (publ) | MUJ | Class II | |
| K213706 | AI-Rad Companion Brain MR | Siemens Healthcare GmbH | QIH | Class II | |
| K213350 | mJOULE System and Accessories | Sciton, Inc. | GEX | Class II | |
| K212773 | ARDO Alyssa | Ardo Medical AG | HGX | Class II | |
| K212677 | aboNT SYRINGE | Nipro Medical Corporation | FMF | Class II | |
| K212522 | Lilliput APD System | Fresenius Medical Care Renal Therapies Group, LLC | FKX | Class II | |
| K212377 | Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 | Ningbo Medkinetic Medical Device Co., Ltd. | NUH | Class II | |
| K220767 | TeleScan | Bb Imaging | LLZ | Class II | |
| K220561 | Disposable Medical Nitrile Examination Gloves | Nanjing Universal Medical Equipment Co., Ltd. | LZA | Class I | |
| K220510 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | MQB | Class II | |
| K220252 | High Retention Attachment System | Zest Anchors LLC | NHA | Class II | |
| K214053 | Amputee Garment for use with Lympha Press Optimal Plus | MEGO AFEK AC Ltd. | JOW | Class II | |
| K214023 | VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) | bioMerieux, Inc. | LON | Class II | |
| K213959 | MagnetOs Flex Matrix | Kuros Biosciences BV | MQV | Class II | |
| K212163 | Coala Heart Monitor | Coala Life AB | DPS | Class II | |
| K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P) | Medtronic, Inc. | MAV | Class II | |
| K220556 | OpenSensorX Series | Dentimax, Inc | MUH | Class II | |
| K220375 | Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) | Summit Glove, Inc. | LZA | Class I | |
| K220373 | Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) | Summit Glove, Inc. | LZA | Class I | |
| K214051 | Neodent Implant System-Helix NGM Compact Surgical Kit Cases | JJGC Industria e Comercio de Materiais Dentarios SA | KCT | Class II | |
| K213363 | CARESCAPE B450, E-musb | GE Healthcare Finland Oy | MHX | Class II | |
| K213336 | Carescape B850, E-musb | GE Healthcare Finland Oy | MHX | Class II | |
| K213181 | CARESCAPE B650, E-musb | GE Healthcare Finland Oy | MHX | Class II | |
| K213133 | Keffort (MC-100, MC-100A) | Oriental Inspiration Limited | KPI | Class II | |
| K212260 | Sensuva Premium Silicone Personal Lubricant | Valencia Naturals, Inc | NUC | Class II | |
| K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning | Brainlab, Inc. | OLO | Class II | |
| K212202 | WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System | OTU Medical Inc | FAJ | Class II | |
| K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | DZE | Class II | |
| K210634 | MCL 31 Dermablate System | Asclepion Laser Technologies GmbH | GEX | Class II | |
| K210419 | BIOTEQ Drainage Catheter BT-PDS-series | Bioteque Corp. | FGE | Class II | |
| K210148 | Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460) | Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. | FYC | Class II | |
| K210146 | Cannulated Compression Device System | Orthopedic Designs North America, Inc. | HWC | Class II | |
| K203842 | Bendit21 Microcatheter | Bend IT Technologies Ltd. | QJP | Class II | |
| K220405 | Amis K Long | Medacta International SA | LZO | Class II | |
| K220103 | LED Therapy Device (Planar LED/Planar LED mini) | Shenzhen Leaflife Technology Co., Ltd. | GEX | Class II | |
| K220027 | Audion ET dilation system | Entellus Medical, Inc. | PNZ | Class II | |
| K214088 | Disposable Surgical Gown | Weihai Hongyu Nonwoven Fabric Products Co.,Ltd | FYA | Class II | |
| K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | FMI | Class II | |
| K214040 | ClearPoint Array System (version 1.1) | ClearPoint Neuro Inc. | HAW | Class II | |
| K214025 | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | Medos International SARL | KRA | Class II |