Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
2024 — Predicate Candidate Screening
3,129 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
124 daysmedian FDA review time
271 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241852 | Nasal Aspirator (NS 13) | Avita Corporation | 2024-12-31 | 187 | 0 |
| K242468 | Power Wheelchair (D10, D12, D15, D17, D20, D37) | Anhui Jbh Medical Apparatus Co., Ltd. | 2024-12-31 | 133 | 0 |
| K243225 | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow M | Genadyne Biotechnologies, Inc. | 2024-12-31 | 84 | 0 |
| K243224 | MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G | ABBOTT MEDICAL | 2024-12-31 | 85 | 0 |
| K241338 | Peak Flow Meter | Chongqing Moffy Innovation Technology Co., Ltd. | 2024-12-31 | 232 | 0 |
| K242989 | Electric Wheelchair (MODEL H) | Nanjing E-Take Medical Apparatus Co., Ltd. | 2024-12-31 | 96 | 0 |
| K243670 | Idys® LIF | Clariance | 2024-12-31 | 34 | 0 |
| K243445 | Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) | Bios S.R.L. | 2024-12-30 | 54 | 0 |
| K242376 | Next Generation Access Platform | Balt USA, LLC | 2024-12-30 | 143 | 1 |
| K243394 | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | 2024-12-30 | 60 | 0 |
| K242804 | PAL Aspiration System | Microaire Surgical Instruments, LLC | 2024-12-30 | 104 | 0 |
| K233119 | 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T | Shenzhen Beacon Display Technology Co., Ltd. | 2024-12-28 | 458 | 0 |
| K241127 | INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. | 2024-12-27 | 248 | 0 |
| K243084 | BioTraceIO Precision (2.0) | Techsomed Medical Technologies , Ltd. | 2024-12-27 | 88 | 0 |
| K240828 | OEC One ASD | Ge Hualun Medical Systems Co. , Ltd. | 2024-12-27 | 276 | 0 |
| K241924 | Elastic Impression Material | Beijing Okvd Biological Technology , Ltd. | 2024-12-27 | 179 | 0 |
| K242252 | Power Wheelchair | Anhui Jbh Medical Apparatus Co., Ltd. | 2024-12-27 | 149 | 0 |
| K243835 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | 2024-12-27 | 14 | 0 |
| K242480 | FLASH EVD System (10-0002) | 7D Surgical ULC | 2024-12-27 | 128 | 0 |
| K241972 | BLUEDIAMOND IMPLANT | Megagen Implant Co., Ltd. | 2024-12-27 | 175 | 0 |
| K240517 | ProSeal™ Vented Universal Vial Adaptor | Epic Medical Pte. , Ltd. | 2024-12-26 | 307 | 0 |
| K243677 | iovera° System | Pacira Biosciences, Inc. | 2024-12-26 | 29 | 0 |
| K243037 | Diode Laser System model Dawn-S | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2024-12-26 | 90 | 0 |
| K233252 | Straumann CARES Visual and Nova Dental CAD | Institut Straumann AG | 2024-12-26 | 455 | 0 |
| K243141 | Diode Laser System (LaserPro D 980); Diode Laser System (Las | Jiangxi Medex Technology Co., Ltd. | 2024-12-26 | 87 | 0 |
| K232966 | FISIOWARM 7.0 | Golden Star Srl | 2024-12-26 | 462 | 0 |
| K243658 | TMC Compression Implant System | Treace Medical Concepts | 2024-12-26 | 29 | 0 |
| K243097 | RM STAR EX with RMS Needle | Bomtech Electronics Co., Ltd. | 2024-12-26 | 87 | 0 |
| K243623 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | 2024-12-24 | 29 | 1 |
| K242434 | Insulin Syringes | Chirana T. Injecta | 2024-12-24 | 130 | 0 |
| K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024-12-23 | 89 | 0 |
| K243177 | SACS PRO | Elastimed , Ltd. | 2024-12-23 | 84 | 0 |
| K242782 | GlassBone Granules | Noraker | 2024-12-23 | 98 | 0 |
| K242573 | NIDO Baby Magnetic Resonance Imaging System | Jiangsu Lici Medical Device Co., Ltd. | 2024-12-23 | 116 | 0 |
| K243248 | INHANCE INTACT™ | Depuy Ireland UC | 2024-12-23 | 73 | 0 |
| K242948 | Adora DRFi (04550010) | Nrt X-Ray A/S | 2024-12-23 | 89 | 0 |
| K243693 | NEO Pedicle Screw System™ | Neo Medical SA | 2024-12-23 | 24 | 0 |
| K242797 | OsteoFlo HydroFiber | SurGenTec, LLC | 2024-12-23 | 98 | 0 |
| K242735 | Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min | Belmont Medical Technologies | 2024-12-23 | 103 | 2 |
| K240975 | Electrosurgical Generator (ES-100); Electrosurgical Generato | Beijing Taktvoll Technology Co., Ltd. | 2024-12-23 | 257 | 0 |
| K241091 | SIMEOX 200 Airway Clearance Device | Inogen, Inc. | 2024-12-23 | 245 | 0 |
| K242143 | Angiography Injector | Shandong Int Medical Instruments Co., Ltd. | 2024-12-23 | 154 | 0 |
| K243103 | Denture Base | Riton 3D Technology Co., Ltd. | 2024-12-23 | 84 | 0 |
| K233614 | Genadyne DUO NPWT | Genadyne Biotechnologies, Inc. | 2024-12-23 | 406 | 0 |
| K240890 | PanopticAI Vital Signs | PanopticAI technologies Limited | 2024-12-23 | 266 | 0 |
| K242403 | Aquilion ONE (TSX-308A/3) V1.5 | Canon Medical Systems Corporation | 2024-12-23 | 132 | 0 |
| K241288 | Noxturnal Web | Nox Medical Ehf | 2024-12-23 | 230 | 0 |
| K242091 | Bolo Button System | Fusion Orthopedics | 2024-12-23 | 159 | 0 |
| K241856 | Sofjec (Single use Needle); Sofjec (Single use Syringe with | Hlb Lifescience Co., Ltd. | 2024-12-23 | 179 | 0 |
| K243121 | SLT Select Fiber Delivery System and Contact Tips (models: S | Jiangxi Medex Technology Co., Ltd. | 2024-12-22 | 83 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda