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 |
|---|---|---|---|---|---|
| K260463 | ZEROS Dental Implant System | Zeros Co., Ltd. | DZE | Class II | |
| K260209 | ENDOFLATOR+; Smart Smoke Evacuation | Karl Storz SE & CO. KG | HIF | Class II | |
| K254213 | Pascall Sensor Unit (PSU1) | Pascall Systems, Inc. | OLT | Class II | |
| K253431 | Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) | Shokz Health Global Limited | LXB | Class II | |
| K253240 | PrecivityAD2 Test | C2N Diagnostics, LLC | SET | Class II | |
| DEN250046 | Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US) | Vitestro | SIW | Class II | |
| K262729 | TeKBrace Solo Soft Tissue Reinforcement Device | Theramicro | QUW | Class II | |
| K262489 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | ODP | Class II | |
| K262479 | TearCare System | Sight Sciences, Inc. | ORZ | Class II | |
| K262135 | Lancing device | Tianjin Huahong Technology Co., Ltd. | QRL | Class II | |
| K261641 | Lower Limb AI (LLAI) | AI Planning Logic, Inc. | QIH | Class II | |
| K260984 | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) | Axora Medical, Inc. | HIH | Class II | |
| K260794 | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR | Kossan International Sdn Bhd | LZA | Class I | |
| K260266 | Tympendi™ (810) | Grace Medical, Inc. | KHJ | Class II | |
| K254256 | LUOFUCON® Wound Matrix | Huizhou Foryou Medical Devices Co., Ltd. | QSZ | Unclassified | |
| K254071 | p17 XR Microcatheter | Wallaby Medical | QJP | Class II | |
| K261500 | KBA3D (v2.4.0) | S.m.a.i.o | LLZ | Class II | |
| K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) | ImpediMed Limited | DSB | Class II | |
| K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions | KLS-Martin L.P. | JEY | Class II | |
| K254250 | MagicScan-1.5, GreenMR Serenity 1.5T | Xingaoyi Medical Equipment Co.,Ltd | LNH | Class II | |
| K260563 | CN-Suite™ | FIND Surgical Sciences Inc. D/B/A FIND Neuro | OLX | Class II | |
| K262639 | BAGUERA® C Cervical Disc Surgical Instruments | Spineart SA | QLQ | Class II | |
| K262571 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular Inc | KNW | Class II | |
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | Scivita Medical Technology Co., Ltd. | FGB | Class II | |
| K262452 | AutoContour (RADAC V6) | Radformation, Inc. | QKB | Class II | |
| K262449 | AdvaView | Advahealth Solutions | LLZ | Class II | |
| K262424 | Willow 12 Guidewire | Arbor Endovascular | MOF | Class II | |
| K262419 | Micrusframe (Mfr100202); Micrusframe (Mfr100253); Micrusframe (Mfr100305); Micrusframe (Mfr100356); Micrusframe (Mfr100407); Micrusframe (Mfr100412); Micrusframe (Mfr100509); Micrusframe (Mfr100517); Micrusframe (Mfr100611); Micrusframe (Mfr100626); Micrusframe (Mfr100713); Micrusframe (Mfr100730); Micrusframe (Mfr100816); Micrusframe (Mfr100829); Micrusframe (Mfr140225); Micrusframe (Mfr140303); Micrusframe (Mfr140304); Micrusframe (Mfr140306); Micrusframe (Mfr140406); Micrusframe (Mf | Cerenovus, Inc. | HCG | Class II | |
| K261890 | 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® | Boehringer Laboratories, LLC | KNT | Class II | |
| K261646 | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | FRO | Unclassified | |
| K261428 | NC Euphora Rapid Exchange Balloon Dilatation Catheter | Medtronic Ireland | LOX | Class II | |
| K261228 | QuickVision Ultimate rTMS | Brain Ultimate, Inc. | OBP | Class II | |
| K260898 | Transpara (2.1.0) | Screenpoint Medical | QDQ | Class II | |
| K260559 | NHanceIT | IMDS Operation B.V. | DQY | Class II | |
| K260438 | Vital Signs Monitor (CLEO2) | Infinium Medical, Inc | MWI | Class II | |
| K260374 | Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal | EMPATICA S.r.l. | GYD | Class II | |
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | BMC Medical Co., Ltd. | CAW | Class II | |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | FMF | Class II | |
| K253562 | medilogFD | Schiller, AG | MWJ | Class II | |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | Cerenovus, Inc. | NRY | Class II | |
| K261626 | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. | EBI | Class II | |
| K261499 | TrachFlush | Aw Technologies ApS | BSK | Class II | |
| K261139 | VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) | Freyja Healthcare, LLC | GCJ | Class II | |
| K261061 | BP Go (BPP-855) | Wellvii Inc | DXN | Class II | |
| K260907 | BIS™ Advance pEEG Module | Medtronic, Inc. | OLW | Class II | |
| K260413 | Levo Gen 2 Tinnitus Therapy System | Levo Medical Corporation | KLW | Class II | |
| K260277 | Mikron Trauma Bone Plate& Screw System | Mikron Makina San. ve Tic. Ltd. Sti. | HRS | Class II | |
| K260211 | Dashboard (P007000) | Hill-Rom Inc. | MSX | Class II | |
| K254201 | Any-Cem | Mediclus Co., Ltd | EMA | Class II | |
| K253808 | AIR Recon DL | GE Healthcare | LNH | Class II |