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 |
|---|---|---|---|---|---|
| K243472 | 1NEED Pro | Campomats | QAI | Class II | |
| K243443 | Expd 4343N1; Expd 4343N; Expd 4343U1; Expd 4343Nu; Expd 4343Np; Expd 3643N1; Expd 3643N; Expd 3643U1; Expd 3643Nu; Expd 3643Np | DRTECH Corporation | MQB | Class II | |
| K243092 | AcuPebble Ox (200) | Acurable Limited | MNR | Class II | |
| K242486 | Tyber Medical Anatomical Plating System | Tyber Medical | HRS | Class II | |
| K242241 | Sunny | ShenB Co., Ltd. | GEI | Class II | |
| K241842 | Luer-Split MAJ-2092 | Olympus Medical Systems Corp. | ODC | Class II | |
| K241791 | Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) | Gigaalaser Company Ltd. | GEX | Class II | |
| DEN240018 | CORIS System | Nanosonics Limited | SEW | Class II | |
| K250494 | The OsteoCentric Bone Plate and Screw System | OsteoCentric Technologies,Inc | HRS | Class II | |
| K250413 | Aglaia LED Beauty Device (BP-D2309) | Shenzhen Perfect Idea Technology Limited | OHS | Class II | |
| K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P | Olympus Medical Systems Corp. | LQR | Class II | |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | iRay Imaging Technology (Haining) Limited | MQB | Class II | |
| K243553 | QuikClot Control+ Hemostatic Device | Teleflex Medical | POD | Class II | |
| K242683 | QP-Prostate® CAD | Quibim S.L. | QDQ | Class II | |
| K242533 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Better Care Plastic Technology Co., Ltd. | LZA | Class I | |
| K242161 | Radlink GPS Pro Imaging | Radlink, Inc. | LLZ | Class II | |
| K241937 | Klarity SGRT System (ARSG-E1A, ARSG-E3A) | Klarity Medical & Equipment (GZ) Co., Ltd. | IYE | Class II | |
| K241783 | FortiVy™ OsteoVy™ Lumbar IBF | VY Spine, LLC | MAX | Class II | |
| K241729 | Hard Splint & Thermo-Adaptive Splint | Whip-Mix Corp. | MQC | Unclassified | |
| K240933 | CarbonCool® System | Global Healthcare SG Sdn. Bhd | NZE | Class II | |
| K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | Hangzhou Laihe Biotech Co.,Ltd. | DJC | Class II | |
| K250514 | UPT Series Medical RO Water Treatment System | Specialty Water Technologies, Inc. | FIP | Class II | |
| K250498 | BPS Wrist Fracture System | Orthonovis, Inc. | HRS | Class II | |
| K250379 | SIGNA Prime Elite | GE Healthcare | LNH | Class II | |
| K244056 | DOC Band 3D | Cranial Technologies, Inc. | OAN | Class II | |
| K243869 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0) | Magstim Inc. | OBP | Class II | |
| K243867 | LAGIS Suction Irrigation System | Lagis Enterprise Co., Ltd. | GCJ | Class II | |
| K243862 | LVivo Software Application | Dia Imaging Analysis, Ltd. | QIH | Class II | |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | OVD | Class II | |
| K243646 | Ziehm Solo FD | Ziehm Imaging GmbH | OWB | Class II | |
| K243504 | Maia (Ahmacme001) | Centervue | MYC | Class II | |
| K242140 | Air Compression Leg Massager (K-705) | Jiale Health Technology Shenzhen Co., Ltd. | IRP | Class II | |
| K241975 | Serv Medical Cdss | Serv Medical Pte., Ltd. | LLZ | Class II | |
| K250439 | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H); Catapult Guide Sheath; 4F; 60cm (US-34060-F-ST-H); Catapult Guide Sheath; 4F; 90cm (US-34090-F-ST-H); Catapult Guide Sheath; 4F; 130cm (US-34130-F-ST-H); Catapult Guide Sheath; 5F; 15cm (US-35015-F-ST-H); Catapult Guide Sheath; 5F; 45cm (US-35045-F-ST-H); Catapult Guide Sheath; 5F; 45cm; Hockey Stick (US-35045-F-HS-H); Catapult Guide Sheath; 5F; 45cm; Multipurpose (US-35045-F-MP-H); Ca | Contract Medical International GmbH | DYB | Class II | |
| K250526 | Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor | Arthrex GmbH | MAI | Class II | |
| K250401 | AION TempShield™ | Aion Biosystems | FLL | Class II | |
| K250267 | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) | Kettenbach GmbH & Co KG | EBF | Class II | |
| K250091 | KOROT Blood Pressure Monitor (KOROT P3 Accurate) | Korot Co., Ltd. | DXN | Class II | |
| K250079 | Ruby XL System | Penumbra Inc. | KRD | Class II | |
| K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) | Aidite (Qinhuangdao) Technology Co., Ltd | EIH | Class II | |
| K243931 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4) | Centers for Disease Control and Prevention | OZE | Class II | |
| K243838 | NEXXT MATRIXX® SI System | Nexxt Spine LLC | OUR | Class II | |
| K243599 | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | FOZ | Class II | |
| K243529 | Solution Administration Sets | Baxter Healthcare Corporation | FPA | Class II | |
| K243353 | One-Fil Putty | Mediclus Co., Ltd | KIF | Class II | |
| K243332 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co.,Ltd. | PTI | Class II | |
| K242811 | BodyTom 64 | Neurologica Corporation, A Subsidiary of Samsung | JAK | Class II | |
| K242323 | Maestro System (REF100) | Moon Surgical, Inc. | QZB | Class II | |
| K242244 | Viewer+ | Lumea, Inc. | QKQ | Class II | |
| K242121 | mBôs (Monogram mBôs TKA System) | Monogram Orthopaedics, Inc. | OLO | Class II |