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 |
|---|---|---|---|---|---|
| K221270 | EchoNavigator R4.0 | Philips Medical Systems Nederland B.V. | LLZ | Class II | |
| K221248 | Rapid LVO | Ischemaview, Inc. | QAS | Class II | |
| K220766 | eMurmur Heart AI | Csd Labs GmbH | DQD | Class II | |
| K220113 | Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) | Shenzhen Finicare Co., Ltd. | DXN | Class II | |
| K214096 | Respire Clear | Respire Medical | LRK | Class II | |
| K213731 | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows | Ever Fortune.Ai, Co., Ltd. | KPS | Class II | |
| K213341 | Fibrillar Collagen Wound Dressing | Collagen Matrix, Inc | KGN | Unclassified | |
| K213065 | Distal Access Catheter | Guangzhou Easycess Medical Co.,Ltd | QJP | Class II | |
| K212729 | Bone Cement-Normal Viscosity | Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda | LOD | Class II | |
| K212699 | Disposable Powder Free Polyethylene Examination Gloves | Mastermax Plastic (Huizhou), Ltd. | LZA | Class I | |
| K212680 | LuxCreo Clear Aligner System | Luxcreo Inc. | NXC | Class II | |
| K211571 | Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit | Zhejiang Longterm Medical Technology Co., Ltd | OMP | Class II | |
| K210987 | IRRIGO Wound Wash Jet System | Inopro, Inc. | FQH | Class II | |
| K203771 | Urea Nitrogen2 | Abbott Ireland Diagnostics Division | CDQ | Class II | |
| K213141 | Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | Shen Wei (USA), Inc. | LZA | Class I | |
| K212597 | Amazing+ Latex Examination Powder Free Gloves | Amazing Rubber Products Pvt. Ltd | LYY | Class I | |
| K212584 | Blue Nitrile Examination Gloves Powder Free | Amazing Rubber Products Pvt. Ltd | LZA | Class I | |
| K220902 | Navagio Lumbar Cage | Kalitec Medical, LLC | MAX | Class II | |
| K220889 | Senhance Surgical System | Asensus Surgical, Inc. | NAY | Class II | |
| K220610 | Solo-L | Aurora Spine, Inc. | OVD | Class II | |
| K220609 | Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) | Encompass Industries Sdn. Bhd. | LZA | Class I | |
| K220593 | Spine Guidance Software, Stryker Q Guidance System | Stryker Leibinger GmbH & Co. KG | OLO | Class II | |
| K220557 | MoistureMeterD Compact, LymphScanner | Delfin Technologies Ltd | OBH | Class II | |
| K220146 | VisAR | Novarad Corp. | OLO | Class II | |
| K213698 | CoLink PCR Plating System | In2bones USA, LLC | HRS | Class II | |
| K212873 | Aspire Cristalle | FUJIFILM Corporation | MUE | Class II | |
| K212838 | Benchmark Intracranial Access System | Penumbra Inc. | QJP | Class II | |
| K212669 | Single Use Hemoclip | Zhejiang Chuangxiang Medical Technology Co., Ltd. | PKL | Class II | |
| K212268 | FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT | FMD Co., Ltd. | DQX | Class II | |
| K220641 | Barrigel Injectable Gel | Palette Life Sciences | OVB | Class II | |
| K220597 | Disposable Surgical Face Mask (FM-34EE,FM-44EE) | Qingdao Bestex Rubber & Plastic Products Co., Ltd | FXX | Class II | |
| K220596 | Wearable Breast Pump (Model S9) | Shenzhen TPH Technology Co., Ltd. | HGX | Class II | |
| K220545 | Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs | HL Rubber Industries Sdn Bhd | LZC | Class I | |
| K220355 | Astroglide Ultra Gentle Gel | Biofilm, Inc. | NUC | Class II | |
| K220249 | Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) | Grand Work Plastic Products Co., Ltd. | LZA | Class I | |
| K220195 | iFuse Bedrock Granite™ Implant System | SI-Bone, Inc. | OUR | Class II | |
| K214074 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs | Hartalega NGC Sdn Bhd | KGO | Class I | |
| K213996 | FreeStyle Libre 3 Continuous Glucose Monitoring System | Abbott Medical | QLG | Class II | |
| K213221 | AMADEO, M-UK1015 (incl. attachments and accessories) | W&H Dentalwerk Buermoss GmbH | ERL | Class II | |
| K213171 | Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) | Meditrina, Inc. | HIH | Class II | |
| K213027 | Laser Hair Growth Comb | Kam Yuen Plastic Products Ltd. | OAP | Class II | |
| K212644 | Aura Storm | Invictus Lighting | FRA | Class II | |
| K212629 | PP Care Nitrile Examination Gloves | Eg Group Product and Services Co., Ltd. | LZA | Class I | |
| K212413 | I-Motion | I-Motion Group Global Iberica SL. | NGX | Class II | |
| K212132 | FreeStyle Libre 3 Continuous Glucose Monitoring System | Abbott Medical | QLG | Class II | |
| K211779 | ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. | Chip Ideas Electronics S.L. | DQD | Class II | |
| K210633 | Amylase2 | Abbott Ireland Diagnostics Division | JFJ | Class II | |
| K221244 | CD Horizon™ Spinal System | Medtronic, Inc. | NKB | Class II | |
| K221180 | Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments | Medtronic Sofamor Danek USA Inc | OLO | Class II | |
| K220793 | InnoVoyce Laser Fiber | InnoVoyce LLC | GEX | Class II |