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 | 2,732 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K102127 | Endotracheal Tube Changers | Instrumentation Industries, Incorporated | LNZ | Class II | |
| K102119 | Sur-G Glov and Maxitex | Terang Nusa (Malaysia) Sdn. Bhd. | KGO | Class I | |
| K101892 | Heine Gamma G7; Heine Gamma G5, Heine Gamma Gp, Heine Gamma Gst, Heine Gamma Xxl Lf Model M-000.09.23X, M-000.09.24X, M- | Heine Optotechnik GmbH & Co. KG. | DXQ | Class II | |
| K101889 | Decompression of Choice and Neuro Decompression Device | Pivotal Health Solutions | ITH | Class II | |
| K101832 | Biopince Ultra Full Core Biopsy Instrument | Medical Device Technologies, Inc. | KNW | Class II | |
| K101702 | Midwest Reprocessing Center Reprocessed Venodyne Sleeves/foot Cuffs | Midwest Reprocessing Center, LLC | JOW | Class II | |
| K101633 | Nova Max Plus Glocose and B-Ketone Control Solution-Mid, High | Nova Biomedical Corporation | JJY | Class I | |
| K101561 | Tx1 Tissue Removal System | Tenex Health | LFL | Unclassified | |
| K101330 | Midwest Reprocessing Center Reprocessed Scd Express Sleeves/ Foot Cuffs, Midwest Reprocessing Center Reprocessed Alp Sle | Midwest Reprocessing Center, LLC | JOW | Class II | |
| K101199 | Guide Wire for Edi Catheter, 8Fr,125cm,5 Each,guide Wire for Edi Catheter, 8Fr,125cm,5 Each,guide Wire for Edi Catheter, | Maquet Critical Care AB | KNT | Class II | |
| K101196 | Accu-Chek Ultrflex Infusion Set | Roche Diagnostics GmbH | FPA | Class II | |
| K100763 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model Watch Bp Home N Bp3mx1-4 | Microlife Intellectual Property GmbH | DXN | Class II | |
| K100635 | Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model: S-44041-002, S-45041-002, S-45504 | Arrow Intl., Inc. | LJS | Class II | |
| K100622 | Belimed Steam Sterilizer, Model Mst-V 3-3-6 | Belimed Sauter AG | FLE | Class II | |
| K100367 | Medicult Vitrification Cooling/warming, Model Ref: 1228, 1229 | CooperSurgical, Inc. | MQL | Class II | |
| K100304 | St Aia Pack Hba1c | Tosoh Bioscience Inc | LCP | Class II | |
| K100141 | 14-Channel Extremity Coil for Magnetom Essenza | Siemens Medical Solutions USA, Inc. | MOS | Class II | |
| K093963 | Quasar Blue Light Therapy System | Silver Bay, LLC | OLP | Class II | |
| K093821 | Fs Aligner | Allesee Orthodontic Appliances, Inc. | NXC | Class II | |
| K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | HAW | Class II | |
| K101645 | Non-Chlorinated, Polymer Coated Powder Free Natural Rubber Latex Examination Gloves and Protein Labeling Claim of | Latexx Manufacturing Sdn.Bhd. | LYY | Class I | |
| K101499 | Journey Cr Knee System | Smith & Nephew, Inc. | JWH | Class II | |
| K101485 | All-Etch, All- Etch with Bac; Uni- Etch, Uni- Etch with Bac; Etch- 37, Etch- 37 with Bac; Dark- Etch, Dark Etch (Blue- E | Bisco Inc | KLE | Class II | |
| K101100 | Crossft Oc Suture Anchor Mode Cfc-4502, Cfc-5502, Cfc-6502, Cfc-4503, Cfc-5503, Cfc-6503 | Conmed Linvatec | MAI | Class II | |
| K101036 | Shimadzu Collimator R-20J | Shimadzu Corp. | IZX | Class II | |
| K100886 | Inbone II Total Ankle Replacement | Wrightmedicaltechnologyinc | HSN | Class II | |
| K100684 | Celltracks Autoprep System Model:9541 | Veridex, LLC | GKH | Class I | |
| K100210 | Trans1 Lateral Intervertebral Fusion Device, T | Trans1 Incorporated | MAX | Class II | |
| K093753 | Mdpo Frame System | Mdpo, LLC | KTT | Class II | |
| K093420 | Xtag Cyp2d6 Kit V3, Model I030c0300 (96 Tests/kit), Tdas Cyp2d6 Software (2030-0254) | Luminex Molecular Diagnostics Inc | NTI | Class II | |
| K082800 | Star/vent Internal Hex Screw Implant | Park Dental Research Corp | DZE | Class II | |
| K102175 | Rapidvue Hcg Test | Ortho-Clinical Diagnostics, Inc. | JHI | Class II | |
| K101728 | Focus (Tm) Echogenic Nerve Stimulating Needle | Cook Inc. | BSP | Class II | |
| K101719 | Tacamo Manual Wheelchair | Dalton Instrument Corp. | IOR | Class I | |
| K100390 | Surgimax/ Surgimax Plus | Elliquence LLC | GEI | Class II | |
| K093847 | Duflo Catheter (Heparin Coated) | Thermopeutix, Inc. | MJN | Class II | |
| K093604 | Etest Moxifloxacin 0.002-32 Ug/ml | Ab Biomerieux | JWY | Class II | |
| K093175 | Wondfo One Step Buprenorphine Urine Test, Oxycodone Urine Test, Propoxphene Urine Test, Multiple Drug of Abuse Urine Tes | Guangzhou Wondfo Biotech Co., Ltd. | DJG | Class II | |
| K102235 | Mantis Spinal System & Mantis Redux Spinal System | Howmedica Osteonics Corp | NKB | Class II | |
| K101632 | Metaflexcoil | NeoCoil, LLC | MOS | Class II | |
| K101358 | Powder-Free Vinyl Patient Examination Gloves | Hebei Handform Plastic Products Co., Ltd. | LYZ | Class I | |
| K101168 | Legend Power Adapter Model: 6475000 | Medtronic Sofamor Danek | HBB | Class II | |
| K093954 | Bioplex 2200 Anti-Ccp Kit on the Bioplex 2200 Multi-Analyte Detection System | Bio-Rad Laboratories Inc. | NHX | Class II | |
| K093373 | Laryngeal Surface Electrode | Spes Medica S.P.A | ETN | Class II | |
| DEN090008 | Erchonia Ml Scanner (Mls) | Erchonia Medical, Inc. | OLI | Class II | |
| DEN090002 | Zeltiq Aesthetics Dermal Cooling Device | Zeltiq Aesthetics Inc | OOK | Class II | |
| K102082 | Extractor Pro Rx Retrieval Ballons, Extractor Pro Xl Retrieval Ballons, Extractor Pro Dl Retrieval Ballons Model M005470 | Boston Scientific Corporation | FGE | Class II | |
| K101875 | Bk Blank Model 20,40,65,90 | Bk Medent Co., Ltd. | EIH | Class II | |
| K101621 | Lite Art | Shofu Dental Corp. | EBF | Class II | |
| K101603 | Beautifil Flow Plus | Shofu Dental Corp. | EBF | Class II |