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 |
|---|---|---|---|---|---|
| K242488 | Soteria E-View | Omega Medical Imaging, LLC | JAA | Class II | |
| K242139 | Mobility Scooter (YL-09B, YL-07) | Yongkang Yile Vehicle Co.,Ltd. | INI | Class II | |
| K242123 | Brainomix 360 e-CTA | Brainomix Limited | LLZ | Class II | |
| K241904 | DermiSphere Dermal Template | Fesariustherapeutics, Inc. | KGN | Unclassified | |
| K250015 | Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive | Ormco Corporation | DYH | Class II | |
| K243737 | Inbella RF System | Inbella Medical Inc. | GEI | Class II | |
| K243363 | Jlk-Ich | JLK, Inc. | QAS | Class II | |
| K242726 | Synapsys VHIT | Inventis SRL | GWN | Class II | |
| K242578 | EVOLVE Nitric Oxide Delivery System | Mallinckrodt Manufacturing LLC | MRN | Class II | |
| K242119 | Innovision-Exii | Dk Medical System | KPR | Class II | |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) | PENTAX of America, Inc. | FDF | Class II | |
| K241757 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K241350 | Clarify DL | GE Medical Systems Israel, Functional Imaging | LLZ | Class II | |
| K241283 | Elemental Granulate | Zinkh NV | OLR | Unclassified | |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | Abbott Medical | MMI | Class II | |
| K240346 | NobelProcera Zirconia Implant Bridge | Nobel Biocare AB | NHA | Class II | |
| K233419 | GBR System | Proimtech Saglik Urunleri Anonim Sirketi | DZL | Class II | |
| K233118 | DUET-V (Model: ESK-3261DV) | Eunsung Global Corp. | GEI | Class II | |
| K243049 | Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C) | Hunan Accurate Bio-Medical Technology Co., Ltd. | DQA | Class II | |
| K242789 | Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) | Dongguan Laiguang Electronic Technology Co., Ltd. | OHS | Class II | |
| K242448 | Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) | Anhui JBH Medical Apparatus Co., Ltd | ITI | Class II | |
| K242334 | Ezra Flash | Ezra AI, Inc. | QIH | Class II | |
| K242326 | Wave Electrode (AE02-60); Wave Electrode (AE02-50) | Bionit Labs S.r.l. | GXY | Class II | |
| K241696 | Ortho AI | Ortho Ai, LLC | QIH | Class II | |
| K241568 | CrystLCare™ PRO Biorestorative, Fluoride-Plus | GreenMark Biomedical, Inc. | LBH | Class II | |
| K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | QJP | Class II | |
| K241005 | Haemostasis Clips | Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | PKL | Class II | |
| K243670 | Idys® LIF | Clariance, Inc. | MAX | Class II | |
| K243225 | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) | Genadyne Biotechnologies, Inc. | BZD | Class II | |
| K243224 | MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801) | Abbott Medical | DQY | Class II | |
| K242989 | Electric Wheelchair (MODEL H) | Nanjing E-Take Medical Apparatus Co., Ltd. | ITI | Class II | |
| K242468 | Power Wheelchair (D10, D12, D15, D17, D20, D37) | Anhui JBH Medical Apparatus Co., Ltd | ITI | Class II | |
| K241852 | Nasal Aspirator (NS 13) | Avita Corporation | BTA | Class II | |
| K241338 | Peak Flow Meter | Chongqing Moffy Innovation Technology Co., Ltd. | BZH | Class II | |
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | Bios S.r.l. | GEX | Class II | |
| K243394 | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | CBK | Class II | |
| K242804 | PAL Aspiration System | MicroAire Surgical Instruments, LLC | QPB | Class II | |
| K242376 | Next Generation Access Platform | Balt USA, LLC | QJP | Class II | |
| K233119 | 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T | Shenzhen Beacon Display Technology Co., Ltd. | PZZ | Class II | |
| K243835 | TiLink-P SI Joint Fusion System | Surgentec LLC | OUR | Class II | |
| K243084 | BioTraceIO Precision (2.0) | Techsomed Medical Technologies, Ltd. | QZL | Class II | |
| K242480 | FLASH EVD System (10-0002) | 7D Surgical ULC | HAW | Class II | |
| K242252 | Power Wheelchair | Anhui JBH Medical Apparatus Co., Ltd | ITI | Class II | |
| K241972 | Bluediamond Implant | Megagen Implant Co., Ltd. | DZE | Class II | |
| K241924 | Elastic Impression Material | Beijing Okvd Biological Technology, Ltd. | ELW | Class II | |
| K241127 | INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. | DZE | Class II | |
| K240828 | OEC One ASD | GE Hualun Medical Systems Co., Ltd. | OXO | Class II | |
| K243677 | iovera° System | Pacira Biosciences, Inc. | GXH | Class II | |
| K243658 | TMC Compression Implant System | Treace Medical Concepts, Inc. | JDR | Class II | |
| K243141 | Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) | Jiangxi Medex Technology Co.,Ltd | GEX | Class II |