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 |
|---|---|---|---|---|---|
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) | Edan Instruments, Inc. | IYN | Class II | |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | DZE | Class II | |
| DEN250032 | LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) | Diasorin Inc. | SGW | Class II | |
| DEN250004 | QIKCAP System | Hai Solutions Inc | SGX | Class II | |
| K253903 | InnoClip Disposable Clip Applier | Taiwan Surgical Corporation | FZP | Class II | |
| K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) | Globus Medical, Inc. | OVE | Class II | |
| K253781 | InnoClip Clip Applier | Taiwan Surgical Corporation | FZP | Class II | |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | FMF | Class II | |
| K253727 | Syndesmosis TightRope PRO | Arthrex GmbH | HTN | Class II | |
| K253664 | SKOUT system | Iterative Health | QNP | Class II | |
| K253661 | TMINI Miniature Robotic System | Think Surgical Inc. | OLO | Class II | |
| K253339 | Theracor | Stimlabs, LLC | KGN | Unclassified | |
| K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | Zhejiang Gongdong Medical Technology Co., Ltd | MMK | Class II | |
| K252981 | EmbraceMini | EMPATICA S.r.l. | LEL | Class II | |
| K252856 | PeekMed web | Peek Health, S.A. | QIH | Class II | |
| K252743 | STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | Ethicon, Inc | GAM | Class II | |
| K252673 | LacertaMatrix | Lacerta Life Science | KGN | Unclassified | |
| K252616 | Portable oxygen concentrator (JLO-190P) | Shenzhen Homed Medical Device Co Ltd | CAW | Class II | |
| K252611 | aprevo® cervical plating system | Carlsmed, Inc. | KWQ | Class II | |
| K252557 | Lumify Diagnostic Ultrasound System | Philips North America LLC | IYN | Class II | |
| K252361 | AccurECG Analysis System (v2.0) | Accurkardia Inc. | DPS | Class II | |
| K252109 | RayStation (2024A SP3) | RaySearch Laboratories AB (publ) | MUJ | Class II | |
| K252068 | MC2 Portable X-ray System | Oxos Medical Inc | OWB | Class II | |
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirs | Corcym Inc. | DTN | Class II | |
| K251764 | Oxygen Concentrator-P2-O5E | Qingdao Kingon Medical Science and Technology Co.,Ltd | CAW | Class II | |
| K251605 | DIMPLO Implant System | DIMPLO Ltd. | DZE | Class II | |
| K251159 | Power wheelchair | Zhenjiang Assure Medical Equipment Co Ltd | ITI | Class II | |
| K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | PKP | Class II | |
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | Bioteque Corp. | FGE | Class II | |
| K250959 | BioticsAI | Bioticsai, Inc. | IYN | Class II | |
| K250756 | Pression Wave PRO External Counter-Pulsation System | Pression, Inc. | DRN | Class II | |
| K243342 | KP Protective Face Mask | KP Trading Co., Ltd. | FXX | Class II | |
| K254063 | iCEM Universal Plus | Kulzer GmbH | EMA | Class II | |
| K253733 | STAR Apollo™ Mapping System | Rhythm AI Inc | DQK | Class II | |
| K253616 | ProtekDilate Vascular Access Kit | Corcym Inc. | DRE | Class II | |
| K253613 | Monkey Rings External Ring Fixation System | Paragon 28 | KTT | Class II | |
| K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | MAX | Class II | |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | Fisher & Paykel Healthcare, Inc. | BTT | Class II | |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Medtronic, Inc. | DQY | Class II | |
| K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) Ltd | JEY | Class II | |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | Diazyme Laboratories, Inc. | DFH | Class II | |
| K253202 | Hoffmann LRF System | Stryker Corp. | KTT | Class II | |
| K253161 | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | MBH | Class II | |
| K253086 | LED Light Therapy Device (Models: SG-FM, SG-FE) | Sunglor Technology Co.,Ltd | OHS | Class II | |
| K253054 | LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | OHS | Class II | |
| K252974 | EMPOWR Knee | Encore Medical, LP | JWH | Class II | |
| K252892 | SCOUT MD Surgical Guidance System | Merit Medical Systems, Inc. | NEU | Class II | |
| K252877 | SANDRO Dual | WONTECH Co., Ltd. | GEX | Class II | |
| K252863 | ClearCalc Model RADCA V2.6 | Radformation, Inc. | MUJ | Class II | |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | Siemens Healthcare GmbH | LNH | Class II |