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 |
|---|---|---|---|---|---|
| K210284 | ManaSport | Manamed LLC | IMI | Class II | |
| K210250 | SpeedCath Compact Male | MEDLINE INDUSTRIES, LP - Northfield | EZD | Class II | |
| K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | PPN | Class II | |
| K220512 | Disposable Surgical Face Mask (M01, M02) | Fomed Industries Inc | FXX | Class II | |
| K213925 | MyoCycle MC-2 (Home / Home + / Pro / Pro +) | Myolyn Inc. | GZI | Class II | |
| K213861 | Cer-S | Cardiocalm SRL | DQK | Class II | |
| K213775 | Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves | Avecena Gloves Sdn Bhd | LYY | Class I | |
| K212530 | IVX Fluid Transfer Set | Omnicell, Inc. | LHI | Class II | |
| K220503 | TENS device-EmeTerm 2, Model: YF-ZTY-E2 | Wat Medical Technology Inc. | GZJ | Class II | |
| K220895 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) | Stryker Corp. | GCJ | Class II | |
| K220840 | 1 Series Phototherapy Equipment | The Daavlin Distributing Co. | FTC | Class II | |
| K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS) | Halyard Health | KNT | Class II | |
| K220574 | Hybrid S70 | Digimed Co., Ltd | EHD | Class II | |
| K213944 | HealthOST | Nanoxai, Ltd. | JAK | Class II | |
| K213889 | PicoStar | Asclepion Laser Technologies GmbH | GEX | Class II | |
| K213708 | ROSA® Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | OLO | Class II | |
| K213683 | Promisemed Fine Biopsy Needle | Promisemed Hangzhou Meditech Co.,Ltd. | KNW | Class II | |
| K213620 | ATUSA™ Automated 3D Breast Ultrasound System | Isono Health Inc. | IYO | Class II | |
| K212981 | MirrorMe3D Modeling System | Mirrorme3D, LLC | LLZ | Class II | |
| K212928 | Lorals | Brazen Goods Inc. dba Lorals | MSC | Class II | |
| K212608 | RibFix Blu Thoracic Fixation System | Biomet Microfixation | HRS | Class II | |
| K212400 | SONON Ultrasound Imaging System, Model: SONON 500L | Healcerion Co., Ltd | IYN | Class II | |
| K212090 | Electric Scooter | Anhui JBH Medical Apparatus Co., Ltd | INI | Class II | |
| K212031 | F&P 850 AirSpiral Adult NIV and NHF Circuit Kit | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K211123 | LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel | HuiZhou Foryou Medical Devices Co., Ltd. | FRO | Unclassified | |
| K203855 | CoNextions TR Tendon Repair System | Conextions Medical | GAQ | Class II | |
| K220605 | Venus Bulk Flow ONE | Kulzer GmbH | EBF | Class II | |
| K220382 | Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple | Jiangsu Bytech Medical Supplies Co., Ltd. | LZA | Class I | |
| K220175 | Gm85 | Samsung Electronics Co., Ltd. | IZL | Class II | |
| K213795 | Videa Caries Assist | VideaHealth, Inc. | MYN | Class II | |
| K213730 | MESI mTABLET TBI diagnostic system, MESI mTABLET TBI | Mesi, Development of Medical Devices, Ltd.; Mesi d.o.o. | JOM | Class II | |
| K213681 | Ivory Glove Powder-Free Nitrile Examination Gloves | Ivory Gloves Sdn. Bhd. | LZA | Class I | |
| K213559 | FEMTO LDV Z8 Femtosecond Surgical Laser | Sie Ag,Surgical Instrument Engineering | OOE | Class II | |
| K213452 | Gems-H | Samsung Electronics Co., Ltd. | PHL | Class II | |
| K212737 | INHANCE™ Reverse Shoulder System | Depuy Ireland UC | PHX | Class II | |
| K212277 | Tempo Tampon | Dong-a Pharmaceutical Co., Ltd. | HEB | Class II | |
| K212158 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products Inc | NEU | Class II | |
| K210183 | Waterlase iPLus | Biolase, Inc. | GEX | Class II | |
| K220872 | Saberscope5 Laparoscope | Xenocor, Inc. | GCJ | Class II | |
| K220866 | EKOS+ Endovascular Device | Boston Scientific Corporation | QEY | Class II | |
| K220543 | Auxo A300, A150 and APod | Auxo Hair, LLC | OAP | Class II | |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2) | SYNOVIS MICRO COMPANIES ALLIANCE, Inc. (a subsidiary of Baxter International Inc.) | DPW | Class II | |
| K213484 | SmoothCool HR System | Jeisys Medical Inc. | GEX | Class II | |
| K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company | QKM | Class II | |
| K220810 | Infinity™ OCT System and PASS OCT Spinal System | Medicrea International | NKG | Class II | |
| K220152 | TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) | Hong Qiangxing (Shenzhen) Electronics Limited | NUH | Class II | |
| K220149 | General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) | Xera Medical Systems & Technology, Ltd. | KPR | Class II | |
| K220075 | Spartan Center Wire | Spartan Micro, Inc. | DQX | Class II | |
| K213930 | Brainlab Elements Guide XT, Guide 3.0 | Brainlab, Inc. | QQC | Class II | |
| K212241 | Quatera 700 | Carl Zeiss Meditec Inc | HQC | Class II |