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 |
|---|---|---|---|---|---|
| K993963 | Sigma Manual Wheelchair | Sigma Distribution & Supply, Inc. | IOR | Class I | |
| K993657 | Acumed Suture Anchor | Acu Med, Inc. | MBI | Class II | |
| K993551 | Socon Spinal System | Aesculap Inc | MNH | Class II | |
| K993550 | Aviva System, Model Sl1010 | American Telecare, Inc. | DRG | Class II | |
| K993531 | Passport 2 Vital Signs Monitor, Model 0998-00-0170-Xx | Datascope Corp. | DSI | Class II | |
| K993377 | Mtm Bioscanner Hdl Test Strips, Over the Counter (OTC) | Polymer Technology Systems | NAQ | Class I | |
| K992779 | A-2000 Bathing Systems; Hydrosonic Bathin System | Medi-Man Rehabilitation Products, Inc. | ILJ | Class II | |
| K992729 | Nipro Luer Adaptor | Nipro Medical Corporation | FMI | Class II | |
| K992584 | Pe 501 Pc-ECG Monitor | Nhe Corp. | MWJ | Class II | |
| K992454 | Venaflow System, Model 30A | Aircast, Inc. | JOW | Class II | |
| K992434 | Itp, Model 1.0 | Nucletron BV | MUJ | Class II | |
| K992053 | Aesculap Vascular Instruments | Aesculap Inc | DXC | Class II | |
| K991862 | Micomed Posterior Doublerod System (Mpds) | Micomed GmbH | MNI | Class II | |
| K990987 | Bio-Absorbable Corkscrew, Model Ar-1920B | Arthrex GmbH | MAI | Class II | |
| K994325 | Synchron Cx Systems Microalbumin Calibrator | Siemens Healthcare Diagnostics Inc. | JIS | Class II | |
| K994056 | Admira | Voco GmbH | EBF | Class II | |
| K994028 | Flipo Xenon Curing Light | Lokki | EBZ | Class II | |
| K993880 | Shanghai Glovmax Enterprise Co, Ltd., Powder-Free Vinyl Patient Examination Gloves | Shanghai Glovmax Enterprise Co.,Ltd | LYZ | Class I | |
| K993859 | Shanghai Glovmax Enterprise Co., Ltd. Pre-Powdered Vinyl Patient Examination Gloves | Shanghai Glovmax Enterprise Co.,Ltd | LYZ | Class I | |
| K993839 | Ena Profile Elisa Test System | Trinity Biotech USA | LLL | Class II | |
| K993795 | Convertors Surgical Drapes | Medtronic, Inc. | KKX | Class II | |
| K993793 | Guthrie Prime Pre-Powdered Patient Latex Examination Glove | Guthrie Medicare Products (Melaka) Sdn Bhd | LYY | Class I | |
| K993567 | Innovative Gloves Latex Examination Gloves Powderfree with Protein Labeling Claim [50 Micrograms or Less] | Innovative Gloves Co;, Ltd. | LYY | Class I | |
| K993472 | Segmented Vaginal Applicator | Mick Radio-Nuclear Instruments, Inc. | JAQ | Class II | |
| K992941 | Lemaitre Biliary Catheter | Vascutech, Inc. | LQR | Class II | |
| K992719 | Amsure Enteral Delivery Pump Set with Spike | Amsino Intl., Inc. | KNT | Class II | |
| K992396 | Biorci Screw | Smith & Nephew Endoscopy, Inc. | HWC | Class II | |
| K992258 | Hot Shot Fluid Warmer IV Fluids | Infra-Med Technologies, Inc. | LDQ | ||
| K992116 | Siememns Infinity Etc02 Pod | Siemens Medical Solutions USA, Inc. | CCK | Class II | |
| K991087 | Hannah Wireless Vital Signs Monitor | Ilife Systems, Inc. | FLS | Class II | |
| K994043 | Correct Touch Latex Powdered Examination Gloves | Biopro (M) Sdn Bhd | LYY | Class I | |
| K994037 | The 4.5Mm Diameter Bicon Dental Implant | Bicon, LLC | DZE | Class II | |
| K994029 | Mdi Sm Test | Micro Detect, Inc. | LLL | Class II | |
| K993973 | Fuji II Lc Capsule | GC America Inc. | EBF | Class II | |
| K993971 | Mdi Ss-B Test Enzyme Immunoassay for the Detection of Autoantibodies to Ss-B in Human Serum | Micro Detect, Inc. | LLL | Class II | |
| K993954 | Synchron Systems Dat Multi-Drug Low and High Urine Calibrators | Siemens Healthcare Diagnostics Inc. | DKB | Class II | |
| K993843 | Mdi RF Test | Micro Detect, Inc. | DHR | Class II | |
| K993664 | Synthetic Vinyl Medical Examination Powdered Gloves | Top Glove Sdn. Bhd. | LYZ | Class I | |
| K993526 | Synea - Ls Low-Speed Handpiece | A-dec, Inc. | EFB | Class I | |
| K993465 | Depuy Ace Calcaneal Peri-Articular Plate | Depuy, Inc. | HRS | Class II | |
| K993460 | Rossmax Automatic Wristwatch Blood Pressure Monitor, Model Z43 | Rossmax International Ltd. | DXN | Class II | |
| K993455 | Flipper Detachable Embolization Coil | Cook Inc. | KRD | Class II | |
| K992959 | Behring Coagulation System (Bcs) | Siemens Healthcare Diagnostics Inc. | JPA | Class II | |
| K992916 | Brainlab Stereotactic Arc | Brainlab, Inc. | HAW | Class II | |
| K992489 | 3M Tr System | 3M Company | EIH | Class II | |
| K992256 | Frolov's Respiration Training Device, Frtd-01 | Intercontinental New Technologies, Inc. | BWF | Class II | |
| K990856 | Heritage Nasal CPAP System, Model P/n 15682 | Bird Products Corp. | BZD | Class II | |
| K971732 | Dental Handpiece | Pauline M. Nicholls | EFB | Class I | |
| DEN000001 | Ohmeda Inovent Delivery System | GE Healthcare | MRN | Class II | |
| K994269 | Titan Rc Tack | Innovasive Devices, Inc. | MAI | Class II |