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 | 2,569 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | Acclarent Inc | LRC | Class I | |
| K190504 | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator | Relievant Medsystems | GXI | Class II | |
| K190409 | MatrixRIB Fixation System | DePuy Synthes | HRS | Class II | |
| K190287 | Arthrex DynaNite® PIP (Hammertoe) Implant | Arthrex GmbH | HTY | Class II | |
| K190278 | AuraGen 123 Suction Lipoplasty System (A123) | Auragen Aesthetics, LLC | MUU | Class II | |
| K190266 | NeoLSD MSMS Kit | Revvity Health Sciences, Inc. | PQW | Class II | |
| K190222 | FilmArray Pneumonia/Pneumoniaplus Control | Maine Molecular Quality Controls, Inc. | PMN | Class II | |
| K190083 | Leaf Photocoagulator | Norlase ApS | HQF | Class II | |
| K183188 | Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF | Richard Wolf Medical Instruments Corp. | FGB | Class II | |
| K182877 | HALF DOME Posterior Lumbar Interbody System | Astura Medical | MAX | Class II | |
| K182430 | Clearfil Majesty Ic | Kuraray Noritake Dental, Inc. | EBF | Class II | |
| K182118 | armor LC | Mavrik Dental Systems, Ltd. | EIE | Class I | |
| K180309 | Manual Wheelchair W54 | Jiangsu Jumao Medical Equipment Co., Ltd. | IOR | Class I | |
| K190851 | HYDRASHIFT 2/4 daratumumab | Sebia, Inc. | CFF | Class II | |
| K190560 | SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface | Nonin Medical, Inc | MUD | Class II | |
| K190540 | Ponto 4 | Oticon Medical AB | LXB | Class II | |
| K190376 | PASS LP Spinal System | Medicrea International | NKB | Class II | |
| K190233 | K-Shield Advantage Port Access Infusion Set (PAIS) | Kawasumi Laboratories Co., Ltd. | FPA | Class II | |
| K183199 | TRIO Handpiece | Omni-Guide Holdings, Inc. | GEX | Class II | |
| K182474 | alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL | Biosystems S.A. | JFJ | Class II | |
| K181671 | Cocoon Convective Warming System | Care Essentials Pty., Ltd. | DWJ | Class II | |
| K190843 | Synchro2 Support Guidewire | Stryker Corp. | MOF | Class II | |
| K190817 | HS Fiber | Riverpoint Medical, LLC | GAT | Class II | |
| K190555 | PowerX Lipo System | Solta Medical, Inc. | QPB | Class II | |
| K190551 | VASERlipo System | Solta Medical, Inc. | QPB | Class II | |
| K190227 | Boomerang™ Anterior Cervical Plate System | Choicespine, LP | KWQ | Class II | |
| K190154 | ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) | bioMerieux, Inc. | JWY | Class II | |
| K183413 | TruWave Disposable Pressure Transducer | Edwards Lifeciences, LLC | DXO | Class II | |
| K183394 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO | GE Healthcare Finland Oy | CCK | Class II | |
| K182646 | Vitreq disposable laser probes, light fibers and Chandelier | Vitreq BV | HQB | Class II | |
| K182231 | Brush Biopsy Set ; Deflectable Brush Biopsy Set | Cook Incorporated | FDX | Class II | |
| K180510 | NS 120P-TRS Airway Pressure Gauge | Instrumentation Industries, Incorporated | CAP | Class II | |
| K190894 | TOTIM Patient Cushion Immobilization System | Essebi Medical SRL | IYE | Class II | |
| K190866 | XmaruView V1 (Xmaru Chiroview, Xmaru Podview) | Rayence Co., Ltd. | LLZ | Class II | |
| K190825 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | DTE | Class II | |
| K190305 | Additive Cap | Intl. Medical Industries | KPE | Class II | |
| K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | ConvaTec Limited | KNT | Class II | |
| K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) | Halyard Health | PNR | Class II | |
| K183342 | SambaScrew 3D SI Fusion System | Orthofix SRL | OUR | Class II | |
| K183045 | Eclipse 2L | Balt USA, LLC | MJN | Class II | |
| K182888 | MRCAT Pelvis | Philips Medical Systems MR Finland | MUJ | Class II | |
| K182092 | BD Intelliport System | Becton Dickinson & Co | PHC | Class II | |
| K190965 | MyDay | CooperVision, Inc. | LPL | Class II | |
| K190655 | SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | OVE | Class II | |
| K190627 | VALO Grand Corded | Ultradent Products Inc. | EBZ | Class II | |
| K190619 | Aspiron(TM) Aspiration Catheter | Meril Life Sciences Private Limited | QEZ | Class II | |
| K190592 | YelloPort Elite Port Access System | Surgical Innovations Ltd | GCJ | Class II | |
| K190553 | HardyCHROM CRE | Hardy Diagnostics | JSO | Class II | |
| K190006 | Magnetic Surgical System | Levita Magnetics International Corp. | PNL | Class II | |
| K182840 | Element Pediatric Wheelchair | Leggero, LLC | IOR | Class I |