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 |
|---|---|---|---|---|---|
| K252647 | Tapestry Biointegrative Implant | Embody, Inc. | OWY | Class II | |
| K252613 | Unscented menstrual three-piece applicator tampon | Unibeauty (Hubei) Technology Co., Ltd. | HEB | Class II | |
| K252285 | Well-Root PT | Vericom Co., Ltd. | KIF | Class II | |
| K251867 | Evis Exera III Duodenovideoscope Olympus Tjf-Q190v (Tjf-Q190v) | Olympus Medical Systems Corp. | FDT | Class II | |
| K251689 | Varios 170 Lux Scaler System (Va170luxs10); Varios 170 Lux Scaler System (Va170luxs11); Varios 170 Scaler System (Va170s11) | Nakanishi Inc. | ELC | Class II | |
| K251167 | uDR Aurora CX | Shanghai United Imaging Healthcare Co., Ltd. | KPR | Class II | |
| K251100 | Ipgtfl-02 | IPG Medical Corporation | GEX | Class II | |
| K251002 | Videa Dental AI | VideaHealth, Inc. | MYN | Class II | |
| K250953 | Equia Lc One | GC America Inc. | EMA | Class II | |
| K250777 | Sonicaid Team3 | Huntleigh Healthcare Ltd. | HGM | Class II | |
| K250649 | Bunkerhill ECG-EF | Bunkerhill Health | QYE | Class II | |
| K250450 | Coated hip implants | Medacta International SA | LZO | Class II | |
| K250408 | Alegria Flash ENA Screen | Zeus Scientific LLC | LLL | Class II | |
| K250128 | Single Use Suction-Evacuation Ureteral Access Sheath | Anhui Happiness Workshop Medical Instruments Co., Ltd. | FED | Class II | |
| K244035 | Portable mesh nebulizer (JM821) | Shenzhen Jermei Medical Device Technology Co.,Ltd | CAF | Class II | |
| K243990 | BondEase 2 Topical Skin Adhesive | OptMed, Inc | MPN | Class II | |
| K243920 | Purema H Hemoconcentrator - Pediatric | Medica USA Inc. | KDI | Class II | |
| K242859 | Vega | Ibramed Equipamentos Medicos | GEX | Class II | |
| K241868 | xR IVD | TEMPUS AI, Inc. | PZM | Class II | |
| DEN240067 | KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) | Cytocell Limited | SFS | Class II | |
| K252428 | Electric Wheelchair (Model P2) | Superpi Robot Co., Ltd. | ITI | Class II | |
| K251905 | Normatec Elite Hip | Normatec Industries, LP | IRP | Class II | |
| K251649 | Sunny Plus (Sunny) | ShenB Co., Ltd. | NFO | Class II | |
| K251597 | InnerView System | Perimetrics, Inc | EKX | Class I | |
| K251479 | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) | Mobarn Medical Devices, LLC | MAX | Class II | |
| K251377 | Magic InBra | Medela AG | HGX | Class II | |
| K250883 | Ultrasonic Probe Um-3R (Um-3R); Ultrasonic Probe Um-G20-29R (Um-G20-29R) | Olympus Medical Systems Corp. | ITX | Class II | |
| K250369 | Axial3D Insight | Axial Medical Printing Limited | QIH | Class II | |
| K252615 | Ruthless Spine RJB | Ruthless LLC dba Ruthless Spine | QWL | Class II | |
| K252035 | DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) | Kamemizu Chemical Industry Co., Ltd. | EBI | Class II | |
| K251902 | Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS) | Vitacore Industries | FXX | Class II | |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | Edwards Lifesciences LLC | KRH | Class II | |
| K251623 | Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) | Shenzhen Yicai Health Technology Co., Ltd | IRP | Class II | |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001) | Manamed LLC | JOW | Class II | |
| K251386 | ECHELON Synergy | FUJIFILM Corporation | LNH | Class II | |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | Abbott Medical | MXD | Class II | |
| K251095 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | Pegavision Corporation | LPL | Class II | |
| K244006 | FG Bone Graft M | Full Golden Biotech Co., Ltd. | LYC | Class II | |
| K243752 | Double Tube Herbst Appliance | The Tmj Clinic PC | LRK | Class II | |
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG | MSS | Class I | |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) | Microtek Medical LLC | LHI | Class II | |
| K251650 | Insight Enhanced™ DRF (EN-1002-01) | Imaging Engineering, LLC | JAA | Class II | |
| K242287 | SFIT Abutment | Cowellmedi Co., Ltd. | NHA | Class II | |
| K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) | Shanghai AnQing Medical Instrument Co., Ltd | FAJ | Class II | |
| K252443 | SpaceFix Shoulder Spacer | G21, S.r.l. | MBB | Class II | |
| K252128 | Zener® (model ZEN-001-B1) | Uvx, Inc. | FRA | Class II | |
| K251914 | IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002) | Miley Technology (Hebei) Co., Ltd | OHT | Class II | |
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited | EGS | Class I | |
| K251780 | iGPS Navigation Instruments | SI-Bone, Inc. | OLO | Class II | |
| K250609 | Sober Self-Test | Sober Ip, LLC | DIC | Class II |