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 |
|---|---|---|---|---|---|
| K190112 | Non-Sterile Zirconia Block | Fine Advanced Compound Co., Ltd. | EIH | Class II | |
| K190008 | Carescape One | GE Healthcare | MHX | Class II | |
| K183213 | IceSense 3, ProSense, MultiSense | Icecure Medical Ltd | GEH | Class II | |
| K193004 | Monopolar Cord | New Deantronics Taiwan Ltd. | GEI | Class II | |
| K193001 | Albumin BCP | Sentinel CH SpA | CJW | Class II | |
| K192607 | LiteWalk | Viasonix Ltd. | IRP | Class II | |
| K192589 | Everyway OTC TENS/EMS Combination | Everyway Medical Instruments Co., Ltd. | NUH | Class II | |
| K192410 | ZS3 and z.one pro Ultrasound Systems | Shenzhen Mindray Bio-Medical Electronics Co.,LTD | IYN | Class II | |
| K192313 | Halo One Thin-Walled Guiding Sheath | C.R. Bard Inc | DYB | Class II | |
| K192229 | Neodent Implant System- GM Titanium Base for Bridge | JJGC Industria e Comercio de Materiais Dentarios SA | NHA | Class II | |
| K192100 | Aveta Disposable Hysteroscope | Meditrina, Inc. | HIH | Class II | |
| K192044 | 4CIS Marlin PEEK ACIF Cage | Solco Biomedical Corp. | ODP | Class II | |
| K191643 | TK Sterile Hypodermic Needle | Anhui Tiankang Medical Technology Co., Ltd. | FMI | Class II | |
| K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | Chongqing Sunkingdom Medical Instrument Co.,Ltd | HKY | Class II | |
| K191305 | Hereaeus Poseidon Microcatheter | Heraeus Medical Components, LLC | KRA | Class II | |
| K190939 | ZOLL Arrhythmia Management Sysyem | ZOLL Manufacturing Corporation | MHX | Class II | |
| K190935 | EZER, Portable X-ray System | Livermoretech,Inc | EHD | Class II | |
| K190881 | Spinal Elements Navigated Instruments | Spinal Elements, Inc | OLO | Class II | |
| K190829 | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) | Wilson-Cook Medical Inc./Cook Endoscopy | FBK | Class II | |
| K190775 | The RHEA Vital Sign Vigilance System | Shenzhen Fiber Medical Technology Co., Ltd. | BZQ | Class II | |
| K183676 | DentiqAir | 3D Industrial Imaging Co., Ltd. | LLZ | Class II | |
| K183144 | uMC 560i | Shanghai United Imaging Healthcare Co., Ltd. | OWB | Class II | |
| K182388 | Krystal Klear Aligners | Shatkin F.I.R.S.T., LLC | NXC | Class II | |
| K192680 | Percusys® Plus Pedicle Screw System | Joimax GmbH | NKB | Class II | |
| K192670 | Neodent Instrument Kit Cases | JJGC Industria e Comercio de Materiais Dentarios SA | KCT | Class II | |
| K192584 | BEACON Caresystem Model 00002144 | Mermaid Care A/S | BZK | Class II | |
| K192580 | STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device | Ethicon, Inc | GAM | Class II | |
| K192189 | Avenir Complete Hip System, Size 0 Coxa Vara | Zimmer GmbH | LZO | Class II | |
| K191898 | Sterile Latex Powder-Free Surgical Gloves | Modern Healthcare Corp. | KGO | Class I | |
| K191667 | Electronic Stethoscope | Hefei Mintti Medical Technology Co., Ltd. China | DQD | Class II | |
| K191614 | BioSticker System | Biointellisense Inc. | DRG | Class II | |
| K191087 | IntraMarX Radiopaque Markers | Anx Robotica Corp. | FFX | Class II | |
| K190824 | Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric | Bluepoint Medical GmbH & Co. KG | CCK | Class II | |
| K190012 | OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid | Medtrade Product, Ltd. | QSY | Unclassified | |
| K182476 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads | Fengh Medical Co., Ltd. | GDW | Class II | |
| K193219 | G Surgical Marksman System | G Surgical Co., Ltd. | NKB | Class II | |
| K193179 | EV1000 Clinical Platform | Edwards Lifesciences LLC | DXG | Class II | |
| K193071 | Bashir Plus Endovascular Catheter | Thrombolex, Inc. | QEY | Class II | |
| K193039 | Single Use Balloon Dilator V (with knife) | Olympus Medical Systems Corp. | KNS | Class II | |
| K192763 | syngo.CT CaScoring | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K192615 | Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) | Synovis Life Technologies, Inc. (Baxter International Inc.) | FTM | Class II | |
| K192595 | ExSpiron 2Xi | Respiratory Motion, Inc. | BZK | Class II | |
| K192572 | CNS Envision | Moberg Research, Inc. | OLT | Class II | |
| K192450 | Precision Casting Solutions Total Hip System | Precision Casting Solution, LLC | LPH | Class II | |
| K192267 | ILUMIEN System with AptiVue Software version D.3 | Abbott Medical | DQO | Class II | |
| K192249 | InMode System with Tone Applicator | Inmode Ltd. | IPF | Class II | |
| K191758 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | Argon Medical Devices, Inc | MMX | Class II | |
| K190725 | Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White | Riverstone Resources Sdn Bhd | LZA | Class I | |
| K193174 | Keos Lumbar IBFD | Keos | MAX | Class II | |
| K192943 | CEDIA Heroin Metabolite (6-AM) assay | Microgenics Corporation | DJG | Class II |