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 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K261418 | Liquick X-treme, Liquick X-treme Plus | Teleflex Medical | EZD | Class II | |
| K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | HWC | Class II | |
| K260597 | Virtue Qa | ProNova Solutions | LHN | Class II | |
| K260117 | Everslide | Special Situations, LLC | NUC | Class II | |
| K254289 | Portable Oxygen Concentrator (OX-1A-E, OX-1B) | Oxytek Medical Technology Co., Ltd. | CAW | Class II | |
| K263054 | BIOFIRE Respiratory Panel 2.1 (RP2.1) | Biofire Diagnostics | QOF | Class II | |
| K262442 | HipStudio Analysis | Replasia BV | LLZ | Class II | |
| K262390 | BoneXpert | Visiana | QIH | Class II | |
| K262299 | Instant-View® hCG Combo II Cassette Test | Alfa Scientific Designs, Inc. | JHI | Class II | |
| K261125 | BodyTom 64 (NL4100); OmniTom Elite (NL5000) | Samsung HME America, Inc., dba NeuroLogica Corp. | JAK | Class II | |
| K254240 | Echo-2 | Neko Health AB | QOK | Class II | |
| K254168 | Actolind® (06.3637. Actolind® Gel Plus) | ACTO GmbH | FRO | Unclassified | |
| K253762 | ErgoSteel (ES0001/696) | Strongback Mobility AG C/O Blueaudit GmbH | IOR | Class I | |
| K243223 | Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) | Bh Group Us, LLC | PBX | Class II | |
| K262982 | Core·it Dual | Spident Co., Ltd. | EBF | Class II | |
| K262547 | KARL STORZ TIPCAM1 Rubina | KALR STORZ SE & Co. KG | OWN | Class II | |
| K262109 | Access NT-proBNP | Beckman Coulter, Inc. | NBC | Class II | |
| K262108 | FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MO | Shanghai Personage Hygiene Products Co., Ltd. | HIS | Class II | |
| K261725 | OtoCompanion (Version 1.0) | Ironsides Medical, Inc. | SHL | Class II | |
| K261368 | Rapid Platform (R6.7) | Ischemaview, Inc. | QIH | Class II | |
| K260940 | BellaTek Bars | ZimVie US Corp, LLC | NHA | Class II | |
| K260512 | Disposable Ureteral Access Sheath | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | FED | Class II | |
| K260416 | ZYLOX Hippo PTA Balloon Dilatation Catheter | Zylox Medtech Co., Ltd. | LIT | Class II | |
| K254280 | F.A.S.T Screw | Steps Ortho | HWC | Class II | |
| K253509 | TriSalus TriNav Advance Infusion System | Trisalus Life Sciences | KRA | Class II | |
| K261859 | Electric Scooter (FDB08, FDB08A, FDB12) | Anhui JBH Medical Apparatus Co., Ltd. | INI | Class II | |
| K252723 | Dynamis Pro Family | Fotona D.O.O. | GEX | Class II | |
| K241973 | SmartIPL_NI System | Lumenis Be, Ltd. | GEX | Class II | |
| K262817 | CrossFAST Integrated Microcatheter Advanced Delivery System | Vantis Vascular, Inc. | DQY | Class II | |
| K262637 | SLIT LAMP SL-D4 (Type: LED) | Topcon Corporation | HJO | Class II | |
| K262599 | Biolinq Shine Autonomous Time-in-Range Microsensor | Biolinq Incorporated | SFU | Class II | |
| K262532 | NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) | ICU Medical | LGZ | Class II | |
| K262524 | Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) | ONE BEAUTY Technology Co., Ltd. | OHT | Class II | |
| K262262 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | FED | Class II | |
| K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | HRS | Class II | |
| K261855 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | LLZ | Class II | |
| K261229 | SCENARIA View Phase 6.0 | Fujifilm Corporation | JAK | Class II | |
| K261102 | UNIDRIVE Select System | Karl Storz SE & CO. KG | HIH | Class II | |
| K261047 | Dental Diode Laser Device (Laser-Pen) | Guilin Kevin Peter Technology Co., Ltd. | GEX | Class II | |
| K260008 | Deterioration Index Version 2 | Epic Systems Corporation | QNL | Class II | |
| K254238 | MINT MONO Sutures | Hans Biomed Corporation | NEW | Class II | |
| K254179 | Drainage Catheter | Canyon Medical, Inc. | FGE | Class II | |
| K254171 | Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) | Shenzhen Mericonn Technology Co., Ltd. | CAF | Class II | |
| K254160 | VacHeal Negative Pressure Wound Therapy System | VacHeal, LLC | OKO | Class II | |
| K254095 | 25G Huber Needle | Martech Medical Products | PTI | Class II | |
| K253419 | Triever Duo Catheter | Inari Medical, Inc. | QEW | Class II | |
| K253146 | Hyperdrive 35 Guidewire | Rapid-Medical , Ltd. | DQX | Class II | |
| K262913 | Protégé™ EverFlex™ Self-expanding Peripheral Stent System | Medtronic, Inc. | FGE | Class II | |
| K262495 | Miru 1day UpSide (midafilcon A) | Menicon Co, Ltd. | LPL | Class II | |
| K262091 | FRAXION Spinal Fixation System | Ortler Global Tibbi Gerecler Anonim Sirketi | NKB | Class II |