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 |
|---|---|---|---|---|---|
| K232162 | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome | Boston Scientific Corporation | KNS | Class II | |
| K231905 | Electro-Spec Steri-Caps | Electro-Spec, Inc. | HTY | Class II | |
| K231434 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA | Class II | |
| K231418 | ENDOGATOR™ Hybrid Irrigation Tubing | Medivators Inc | OCX | Class II | |
| K231341 | Organic cotton tampon, Viscose tampon | Zhejiang Tianqing Manufacturing Technology Group Co.,Ltd. | HEB | Class II | |
| K231208 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co. KG | HBW | Class II | |
| K231054 | V-Laser | WONTECH Co., Ltd. | GEX | Class II | |
| K231018 | Yomi Robotic System | Neocis Inc. | PLV | Class II | |
| K230663 | Density | Jeisys Medical Inc. | GEI | Class II | |
| K230608 | SPICCA Stand-Alone Cervical Fusion Cages | Southern Medical (Pty) Ltd | OVE | Class II | |
| K230607 | SPICCA Cervical Fusion Cages | Southern Medical (Pty) Ltd | ODP | Class II | |
| K223660 | SaintView | Inviz Corporation | LLZ | Class II | |
| K230756 | TK Pre-Filled Normal Saline Flush Syringe | Anhui Tiankang Medical Technology Co., Ltd. | NGT | Class II | |
| K230172 | Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | DQA | Class II | |
| K223584 | Pre-Filled Normal Saline Flush Syringe | Anhui Tianyang Pharmaceutical Co., Ltd | NGT | Class II | |
| K231823 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment Inc. | MRN | Class II | |
| K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | Prevest Denpro Limited | KLE | Class II | |
| K231493 | NITINEX Memory Compression Staple | Vilex LLC | JDR | Class II | |
| K231439 | Powder Free White, Black, and Purple Nitrile Examination Glove | S&S Glove Corporation | LZA | Class I | |
| K231409 | Erchonia FX-405 | Erchonia Corporation | NHN | Class II | |
| K231408 | Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile | Shandong Intco Medical Products Co Ltd | LZA | Class I | |
| K230642 | Electronic Blood Pressure Monitor | Dongguan Kangweile Electronic Technology Co., Ltd | DXN | Class II | |
| K230632 | VersiHD with GuideMe software | NxStage Medical Inc | KDI | Class II | |
| K230626 | Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™ | GE Medical Systems Information Technologies, Inc. | MWI | Class II | |
| K230420 | Dr. pen Microneedling System | Guangzhou Ekai Electronic Technology Co.,Ltd. | QAI | Class II | |
| K230384 | PolyWear® Personal Protective Level 3 Gown | Polyconversions, Inc. | QPC | Class II | |
| K230297 | PMT Expandable Cage (PMT EXP) | Providence Medical Technology, Inc. | MRW | Unclassified | |
| K223856 | NuEra Tight RF Family | Bios S.r.l. | GEI | Class II | |
| K223840 | eRapid Nebulizer System | Pari Respiratory Equipment, Inc. | CAF | Class II | |
| K223519 | Carex Hybrid Personal Lubricant | Karex Industries Sdn Bhd | NUC | Class II | |
| K223463 | Otsuka Digital Feedback Device-RW | Otsuka America Pharmaceutical, Inc | OZW | Class II | |
| K222888 | BlueStar CGM insulin dose calculator | Welldoc | QRX | Class II | |
| K231420 | Aura 10 PET/CT | Xeos Medical | QXL | Class II | |
| K231415 | EnSite™ X EP System | Abbott Medical | DQK | Class II | |
| K231380 | AirLife DuoTherm™ Humidification System | Jaeger Medical GmbH | BTT | Class II | |
| K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | I-SENS, Inc. | NBW | Class II | |
| K230428 | Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2 | Ambu A/S | EOQ | Class II | |
| K230268 | ZenPro 40 | BLUECORE Company Co., Ltd. | GEX | Class II | |
| K223711 | ANNE One | Sibel Health Inc. | DRG | Class II | |
| K223608 | GEM Premier 7000 with IQM3 | Instrumentation Laboratory Co. | CHL | Class II | |
| K223500 | SuperBall Meniscal Repair System | Arcuro Medical Ltd. | GAT | Class II | |
| K223445 | ArtiFascia | Nurami Medical Ltd | GXQ | Class II | |
| K222850 | HAVAb IgG II | Abbott Medical | LOL | Class II | |
| K221925 | Id Now Covid-19 2.0 | Abbott Diagnostics Scarborough, Inc. | QWR | Class II | |
| K213134 | Accu-Chek Solo micropump system with interoperable technology | Roche Diabetes Care, Inc. | QFG | Class II | |
| K213131 | Accu-Chek Guide Solo diabetes manager blood glucose monitoring system | Roche Diabetes Care, Inc. | NBW | Class II | |
| K232039 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Grand Work Plastic Products Co., Ltd. | LZA | Class I | |
| K231885 | Medline UNITE® REFLEX® Nitinol Staple System | MEDLINE INDUSTRIES, LP - Northfield | JDR | Class II | |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | Ortho-Clinical Diagnostics, Inc. | NIG | Class II | |
| K231394 | Intense Pulsed Light System | Smedtrum Medical Technology Co. Ltd. | ONF | Class II |