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 | 2,618 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K142263 | Applanation Tonometer | Shanghai Mediworks Precision Instruments Co., Ltd. | HKY | Class II | |
| K160968 | iPulse SmoothSkin Gold Hair Removal Device | Cyden Limited | OHT | Class II | |
| K160716 | The Nanostim Introducer Kit | Abbott Medical | DYB | Class II | |
| K160348 | Cx30n (Cx30pqx) | Wide Corporation | PGY | Class II | |
| K160346 | Mx30n(mx30tqs) | Wide Corporation | PGY | Class II | |
| K153696 | Chattanooga Revolution Wireless | DJO, LLC | IPF | Class II | |
| K153251 | Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff | Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. | DXQ | Class II | |
| K152959 | Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes | Sybron Dental Specialties, Inc. | KIF | Class II | |
| K152364 | uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS | Pc Marketing, Inc. | LEJ | Class II | |
| K152111 | Symmetry Surgical Quad-Lock Container System | Symmetry Surgical GmbH | KCT | Class II | |
| K143605 | Nutraseb Facial Cream | Isdin Corp. | FRO | Unclassified | |
| K143477 | Nitrile Patient Examination gloves, Powderfree, Blue color | Primus Gloves Pvt Limited | LZA | Class I | |
| K160693 | Neptune E-SEP Smoke Evacuation Pencil | Stryker Corp. | GEI | Class II | |
| K160608 | NormaTec Pulse and NormaTec Pulse Pro | Normatec Industries, LP | IRP | Class II | |
| K160021 | Varian Sterilization Boxes | Varian Medical Systems, Inc. | JAQ | Class II | |
| K153653 | DICOM Viewer | Brainlab, Inc. | LLZ | Class II | |
| K153419 | NuVasive CoRoent Thoracolumbar System | Nu Vasive, Incorporated | MAX | Class II | |
| K153255 | Aero Chrome* Breathable Performance Surgical Gown | Halyard Health | FYA | Class II | |
| K153174 | Ketac Universal Aplicap | 3M Deutschland GmbH | EMA | Class II | |
| K153061 | Juno VPAP ST-A | ResMed Corp | MNS | Class II | |
| K153038 | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit | Medtronic, Inc. | MAV | Class II | |
| K152538 | JRP Wound Spreader | J.R. Parker, LLC | GAD | Class I | |
| K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System | PENTAX of America, Inc. | GEH | Class II | |
| K151953 | A&D Medical TM-2657 Family of Digital Blood Pressure Monitors | A&D Company, Ltd. | DXN | Class II | |
| K151704 | Diplomat® Spinal System | Signus Medizintechnik GmbH | NKB | Class II | |
| K151608 | 4plus6Line Abutment System | OT Medical GmbH | NHA | Class II | |
| K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer | Globus Medical, Inc. | MAX | Class II | |
| K160517 | ARIES System | Luminex Corporation | OOI | Class II | |
| K160461 | Arthrex iBalance BiCompartmental Arthroplasty System | Arthrex GmbH | KRR | Class II | |
| K160376 | EndoSize | Therenva SAS | LLZ | Class II | |
| K153753 | TelioCAD Multi | Ivoclar Vivadent, Inc. | EBG | Class II | |
| K153229 | Superbium | Bios S.r.l. | GEX | Class II | |
| K152794 | Cytosponge Cell Collection Device | Medtronic, Inc. | EOX | Class II | |
| K152430 | All Poly Tibial Component | United Orthopedic Corp. | JWH | Class II | |
| K152107 | HealthChek Network Health Station | Healthchek Network, LLC | DXN | Class II | |
| K151977 | icotec Pedicle System | Icotec AG | NKB | Class II | |
| K150921 | Orbit Infusion Set | Ypsomed AG | FPA | Class II | |
| K160390 | Map-it Diagnostic Mapping Catheters | Access Point Technologies, EP Inc. | DRF | Class II | |
| K153377 | Hoffmann LRF (Limb Reconstruction Frame) System | Stryker Corp. | KTT | Class II | |
| K153043 | Noris Medical MBI Dental Implant System | Noris Medical Ltd. | DZE | Class II | |
| K152995 | BioMonitor 2-AF, BioMonitor 2-S | BIOTRONIK AG | MXD | Class II | |
| K152836 | TREFOIL System | Nobel Biocare AB | DZE | Class II | |
| K152581 | LifeGlobal Micro Tips | Life Global Group, LLC | MQH | Class II | |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Arthrosurface, Inc. | KWD | Class II | |
| K152056 | Winco Model S550 Stretchair | Winco Manufacturing, LLC | INK | Class II | |
| K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls | Inova Diagnostics, Inc. | LSW | Class II | |
| K160579 | Xmaru View V1 and Xmaru PACS, Medical Image Processing Software | Rayence Co., Ltd. | LLZ | Class II | |
| K160407 | spineEOS | Onefit Medical | LLZ | Class II | |
| K160299 | geko(TM) Plus R-2 Neuromuscular Stimulator | Firstkind Ltd | IPF | Class II | |
| K160266 | ICONACY(TM) I-Hip(TM) | Iconacy Orthopedic Implants, LLC | LPH | Class II |