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 |
|---|---|---|---|---|---|
| K220404 | STERRAD NX with ALLClear Technology | Advanced Sterilization Products | MLR | Class II | |
| K213832 | AAMI3 Isolation Gown | Hubei Xinxin Non-woven Co., Ltd | FYC | Class II | |
| K213583 | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems | Philips Medical Systems Nederland B.V. | LNH | Class II | |
| K212376 | Caas Qardia | PIE Medical Imaging B.V. | LLZ | Class II | |
| K211665 | SONON Ultrasound Imaging System, Model: SONON300C | Healcerion Co., Ltd | IYN | Class II | |
| K210516 | Clicky Cross | Yomura Technologies Inc. | FMG | Class II | |
| K220626 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | FOZ | Class II | |
| K220491 | Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs | Hainan Asther Medical Equipment Co., Ltd. | LZC | Class I | |
| K221174 | Telepack + | Karl Storz Endoscopy-America, Inc. | FET | Class II | |
| K221144 | Pedra-1417Mc, Pedra-1417Mg, Pedra-1417Fc, Pedra-1417Fg | Radisen Co Ltd | MQB | Class II | |
| K221116 | XACT ACE Robotic System | Xact Robotics, Ltd. | JAK | Class II | |
| K221115 | Flow-Nail | Flow-Fx, LLC | HSB | Class II | |
| K221106 | Quantib Prostate | Quantib B.V. | LLZ | Class II | |
| K221099 | Arthrex Self-Punching PushLock Suture Anchor | Arthrex GmbH | MAI | Class II | |
| K220760 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc | MIB | Class II | |
| K220757 | Argo Knotless SP Anchor | ConMed Corporation | MBI | Class II | |
| K220749 | Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP | Unimax Medical Products Co., Ltd. | FXX | Class II | |
| K220589 | MAGNETOM Skyra Fit | Siemens Medical Solutions USA, Inc. | LNH | Class II | |
| K220429 | Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile | One Glove Industrial Sdn Bhd | LZA | Class I | |
| K220411 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | Stryker Sustainability Solutions | NUJ | Class II | |
| K220186 | Zone Specific AIM | ConMed Corporation | GAT | Class II | |
| K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System | Mirus, LLC | OVD | Class II | |
| K213785 | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid | Limacorporate S.p.A. | KWS | Class II | |
| K213535 | Sterile Safety Hypodermic Needles for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | FMI | Class II | |
| K213203 | Provena(TM) Midline Catheter | C.R. Bard Inc | PND | Class II | |
| K213137 | INTDose | Carina Medical LLC | IYE | Class II | |
| K213119 | Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens | Innova Vision Inc. | LPL | Class II | |
| K212875 | Spectral CT on Rails | Philips Medical Systems Nederland B.V. | JAK | Class II | |
| K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | Prevest Denpro Limited | EJK | Class II | |
| K210615 | Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) | Thompson Surgical Instruments, Inc. | GZT | Class II | |
| K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution Filter | Nephros Inc | KDI | Class II | |
| K221001 | IPL Home Use Hair Removal Device | Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. | OHT | Class II | |
| K220747 | Power Wheelchair (N5515B) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | ITI | Class II | |
| K220740 | Power Wheelchair, W5907 (Q50 R Carbon) | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | ITI | Class II | |
| K220738 | Motive Knee Wrap | Cymedica Orthopedics, Inc. | IPF | Class II | |
| K220723 | Hand Trauma Screw System | Skeletal Dynamics, Inc | HWC | Class II | |
| K220442 | Synguard Nitrile Exam Glove | Tianjin Aoshang Outdoor Equipment Co., Ltd. | LZA | Class I | |
| K220430 | Capsulo | Quantel Medical | HQF | Class II | |
| K220397 | ANSiStim-PP | Dyansys, Inc. | NHI | Class II | |
| K220118 | Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves | KL-Kepong Rubber Products Sdn. Bhd. | LZA | Class I | |
| K220105 | Saige-Dx | Deephealth | QDQ | Class II | |
| K213811 | Sterile Hypodermic Syringes for Single Use | Berpu Medical Technology Co., Ltd. | FMF | Class II | |
| K213491 | Universal Pilot Guidance Instrument System | CTL Medical Corporation | OLO | Class II | |
| K213025 | Laser hair growth helmet | Kam Yuen Plastic Products Ltd. | OAP | Class II | |
| K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | |
| K210937 | Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 | Alicn Medical Shenzhen, Inc | FLL | Class II | |
| K220662 | Disposable Barrier Sleeves | Premium Plus (Dongguan) Limited | PEM | Class II | |
| K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | FDT | Class II | |
| K220446 | Versana Balance | GE Healthcare | IYN | Class II | |
| K220250 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs | Grand Work Plastic Products Co., Ltd. | LZA | Class I |