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 |
|---|---|---|---|---|---|
| K241225 | Silverlon® Wound Contact, Burn Contact Dressing | Argentum Medical, LLC | FRO | Unclassified | |
| K240967 | ValvuloPro Valvuloplasty Balloon Catheter | Dongguan TT Medical, Inc. | OZT | Class II | |
| K240898 | SteriTite rigid reusable sterilization container with MediTray Products | Case Medical, Inc. | KCT | Class II | |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System | B.Braun Medical, Inc. | DTK | Class II | |
| K233808 | LW Narrow Implant System | Ossvis Co., Ltd. | DZE | Class II | |
| K233555 | AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask | Respironics, Inc. | BZD | Class II | |
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | Axis-Shield Diagnostics, Ltd. | CDD | Class II | |
| K241963 | Weray | PICOPACK Inc. | EHD | Class II | |
| K241539 | Activmotion S | Newclip Technics | HRS | Class II | |
| K240531 | SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment | BioHorizons Implant Systems Inc | NHA | Class II | |
| K240446 | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + | Shiva Products | KIF | Class II | |
| K240280 | Nano-Check™ RSV Test | Nano-Ditech Corporation | GQG | Class I | |
| K242050 | Montage Settable Bone Putty | Orthocon, Inc. | MQV | Class II | |
| K241912 | Biocharge | Nanofiber Solutions LLC | MAI | Class II | |
| K241906 | BioBrace® Reinforced Implant | ConMed Corporation | OWW | Class II | |
| K241464 | ARx® SAI Implant System | Life Spine | OUR | Class II | |
| K241209 | EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) | Cook Ireland Ltd. | FCG | Class II | |
| K240359 | PowerGlide Pro™ Midline Catheter | Becton, Dickinson and Company (Bard Access Systems, Inc.) | FOZ | Class II | |
| K240326 | Solar™ Lumbar Interbody Fusion System | Degen Medical | MAX | Class II | |
| K234125 | AtriClip FLEX-Mini LAA Exclusion System (ACHM) | AtriCure, Inc. | PZX | Class II | |
| K233723 | Medical surgical mask | Guangdong Kingfa Sci.&tech.co.,Ltd. | FXX | Class II | |
| K241898 | Symbia SPECT and SPECT/CT Systems | Siemens Healthineers AG | KPS | Class II | |
| K241883 | DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50) | Black Forest Medical GmbH | HBL | Class II | |
| K241866 | InnovaMatrix®FD | ConvaTec Triad Life Sciences, LLC | KGN | Unclassified | |
| K241845 | Introcan Safety® 2 IV Catheter | B.Braun Medical, Inc. | FOZ | Class II | |
| K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | Siemens Healthcare Diagnostics Inc. | MRR | Class I | |
| K241515 | NEXA™ NPWT System | Nexa Medical, Ltd. | OMP | Class II | |
| K241494 | Pantheon Pedicle Screw and Iliac Bolt Fixation System | Pantheon Spinal LLC | NKB | Class II | |
| K241187 | Alien Aligners | Alien Milling Technologies | NXC | Class II | |
| K241078 | Tandem Mobi Insulin Pump with interoperable technology | Tandem Diabetes Care, Inc. | QFG | Class II | |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) | MEDLINE INDUSTRIES, LP - Northfield | EZD | Class II | |
| K240509 | STAR Apollo™ Mapping System | Rhythm AI Inc | DQK | Class II | |
| K240401 | ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) | Origyn Medical Technology (Hangzhou) Co., Ltd | HIH | Class II | |
| K240246 | Accusafe Transseptal Guidewire (GTR31180, GTR31230) | Synaptic Medical Corporation | DRC | Class II | |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | Bausch & Lomb Incorporated | HQC | Class II | |
| K234131 | Resolv Endoscopic Hemostat System | Hemostasis, LLC | QAU | Class II | |
| K233994 | VOLT™ Proximal Humerus 3.5 Plating System | Synthes GmbH | HRS | Class II | |
| K233725 | Spine Navigation System | Medivis, Inc. | OLO | Class II | |
| K233530 | EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM) | DRTECH Corporation | KPR | Class II | |
| K233501 | “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) | Largan Medical Co., Ltd. | MNR | Class II | |
| K233287 | Vent Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co.,Ltd | LHI | Class II | |
| K231776 | Cell-Free DNA BCT | Streck LLC | QMA | Class II | |
| K220328 | EasyStat 300 | Medica Corp. | CGA | Class II | |
| K241887 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) | Cosmo Artificial Intelligence - Ai, Ltd. | QNP | Class II | |
| K241864 | Grappler Interference Screw System | Paragon 28 | MBI | Class II | |
| K241361 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex GmbH | GCJ | Class II | |
| K241203 | PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT) | Dongguan Hunter Electronic Technology Co., Ltd. | OHS | Class II | |
| K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories | Stryker Leibinger GmbH & Co. KG | OLO | Class II | |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | Siemens Healthcare Diagnostics Inc. | MMI | Class II | |
| K241063 | s-Clean ScanHealing Abutment | Dentis Co.,Ltd | NHA | Class II |