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 |
|---|---|---|---|---|---|
| K210448 | Adhesive Electrode | Shaoxing Yingtuo Healthcare Co.,Ltd. | GXY | Class II | |
| K203636 | PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS; Rectum Types: PT2252-AG, PTHP-AG, PTMQ-AG, PTSW-AG, PTSM-15AG, PTSL-AG, PTMR-AG | JKH USA, LLC | FLL | Class II | |
| K203084 | Ablamap Software | Ablacon, Inc. | DQK | Class II | |
| K201560 | Auto Lung Nodule Detection | Samsung Electronics Co., Ltd. | MYN | Class II | |
| K212103 | StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 | Fona S.R.L | MUH | Class II | |
| K212070 | KMTI S141 Lumbar Interbody Fusion System | Kyocera Medical Technologies, Inc. | MAX | Class II | |
| K212054 | Senhance Surgical System | Asensus Surgical, Inc. | NAY | Class II | |
| K211903 | Shoreline Threaded TruProfile® Plate | SeaSpine Orthopedics Corporation | KWQ | Class II | |
| K211630 | VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) | bioMerieux, Inc. | LON | Class II | |
| K211322 | Paratrooper Plantar Plate Repair System | Paragon 28 | MBI | Class II | |
| K211041 | Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681 | Shenzhen Yuezhongxing Technology Co.,Ltd | DXN | Class II | |
| K210805 | Ceribell Instant EEG Headband | Ceribell, Inc. | GXY | Class II | |
| K210090 | Impulse AM Interbody Fusion System | Degen Medical | MAX | Class II | |
| K211390 | Nitrile Blue Powder-free Examination Glove | Cardinal Health200, LLC | LZA | Class I | |
| K211255 | Surgical Mask | Tianchang Kanghui Protective Products Co, Ltd. | FXX | Class II | |
| K203554 | AnyOne External Implant System | Megagen Implant Co., Ltd. | DZE | Class II | |
| K212345 | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | DQK | Class II | |
| K212038 | K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage | K&J Consulting Corp. | ODP | Class II | |
| K212023 | Virage Navigation System | Highridge Medical, LLC | OLO | Class II | |
| K212004 | MyoSPECT, MyoSpect ES | GE Healthcare | KPS | Class II | |
| K211995 | Sonendo Filling Material 5C | Sonendo Inc | KIF | Class II | |
| K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | Given Imaging Ltd. (Medtronic) | NEZ | Class II | |
| K211524 | LOGIQ E10s, LOGIQ Fortis | GE Healthcare | IYN | Class II | |
| K211413 | BEE PLIF Cage | Ngmedical GmbH | MAX | Class II | |
| K211373 | SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K210676 | XSTAT 30 Pouch | Revmedx Inc | PGZ | Class II | |
| K210610 | PrimeTaper EV Dental Implant | Dentsply Sirona Inc | DZE | Class II | |
| K210530 | WOLF Thrombectomy System, 6F | Devoro Medical, Inc. | QEW | Class II | |
| K210502 | Trevo NXT ProVue Retriever | Stryker Corp. | POL | Class II | |
| K210373 | Clear Aligners | Shenzhen Yinuo Dental Technology Co.Ltd | NXC | Class II | |
| K210122 | Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) | Osteonic Co., Ltd. | MAI | Class II | |
| K210047 | Stiletto Extended Dwell Catheter | Piper Access, LLC | PND | Class II | |
| K203696 | RBknee | Radiobotics ApS | LLZ | Class II | |
| K203613 | ENFit Reusable Enteral Syringe | Shantou Wealy Medical Instrument Co., Ltd. | PNR | Class II | |
| K203251 | SOLOPASS System | Intravent Medical Partners LP | HAW | Class II | |
| K202861 | Needle Stimulator | Wuxi Jiajian Medical Instrument Co., Ltd | BWK | Unclassified | |
| K202781 | Neuspera Neurostimulation System (NNS) | Neuspera Medical, Inc. | GZF | Class II | |
| K202752 | AXS Vecta 46 Intermediate Catheter | Stryker Corp. | QJP | Class II | |
| K202746 | Surgical mask | Ningbo Jingeao Electronics, Inc. | FXX | Class II | |
| DEN200064 | Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System | Canary Medical USA LLC | QPP | Class II | |
| K212355 | Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large | Checkpoint Surgical Inc | ETN | Class II | |
| K212048 | Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) | Intuitive Surgical, Inc. | EOQ | Class II | |
| K211634 | Hypodermic Needle-Pro EDGE Safety Device | Abbott Medical | FMI | Class II | |
| K211240 | ViperCross Support Catheters | Cardiovascular Systems Incorporated | DQY | Class II | |
| K210991 | Disposable Sterile Syringe, Disposable Sterile Syringe with Needle | Guangdong Antmed Co., Ltd. | FMF | Class II | |
| K210898 | Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) | Tangshan Lanhai Medical Supplies Co., Ltd. | LZA | Class I | |
| K210745 | Heel Incision Safety Lancet | Sterilance Medical (Suzhou) Inc. | FMK | Class II | |
| K210288 | Disposable Manual Resuscitator | Xiamen Compower Medical Tech. Co., Ltd. | BTM | Class II | |
| K210131 | ComfortGuard Surgical Isolation Gown | GRI-Alleset, Inc. | FYC | Class II | |
| K202952 | Amber Mill Q Series & Amber Mill Direct Series | Hass Corp. | EIH | Class II |