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 |
|---|---|---|---|---|---|
| K203748 | SeptiCyte RAPID | Immunexpress, Inc | PRE | Class II | |
| K212722 | Nitrile Examination Gloves | Wuhan Huirui Technology Co., Ltd. | LZA | Class I | |
| K212488 | Synthetic Nitrile Examination Gloves | Shandong Hongxin Chemicals Co., Ltd. | LYZ | Class I | |
| K211594 | Trevo Trak 21 Microcatheter | Stryker Corp. | QJP | Class II | |
| K211541 | MammoScreen 2.0 | Therapixel | QDQ | Class II | |
| K211139 | CUBE Air Purifier | Samsung Electronics Co., Ltd. | FRA | Class II | |
| K210833 | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula | Abbott Medical | JOH | Class II | |
| K210782 | Tablo Cartridge | Outset Medical, Inc. | FJK | Class II | |
| K202842 | Medical surgical mask | Henan Huibo Medical Co., Ltd | FXX | Class II | |
| K202537 | ALTMS Magnetic Stimulation Therapy System | Remed Co., Ltd. | OBP | Class II | |
| K213455 | ControlRad Select Model Z | Controlrad, Inc. | OWB | Class II | |
| K213214 | Xpert Wrist | Newclip Technics | HRS | Class II | |
| K212633 | Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue | String King Lacrosse, LLC | FYC | Class II | |
| K212558 | MicroPen EVO | Eclipse Medcorp, LLC | QAI | Class II | |
| K212223 | Atellica CH Enzymatic Creatinine_3 (ECre3) | Siemens Healthcare Diagnostics Inc. | JFY | Class II | |
| K211983 | AMRA Profiler | Amra Medical AB | LNH | Class II | |
| K211894 | Trachealator | Disa Medinotec (Pty) Ltd | KTI | Class II | |
| K211744 | Non-Contact Infrared Thermometer, model HL710H | Health & Life Corporation | FLL | Class II | |
| K211650 | The Radian MIS Bunion System | Nvision Biomedical Technologies, Inc | HRS | Class II | |
| K211463 | Regulora | Metame Health, Inc. | QMY | Class II | |
| K211345 | C-30 Crown Kit | Perfect Fit Crowns, LLC | EBF | Class II | |
| K211295 | Surgical Mask (sterile) | Nanjing 3H Medical Products Co.,Ltd. | FXX | Class II | |
| K211169 | Bronchoscope System | Shanghai AnQing Medical Instrument Co., Ltd | EOQ | Class II | |
| K210009 | Guiding Catheter | Centerpoint Systems LLC | DQY | Class II | |
| K213454 | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm | Medtronic Powered Surgical Solutions | HBE | Class II | |
| K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | OLP | Class II | |
| K212529 | Hypotension Decision Assist Model HDA-OR2 | Directed Systems Ltd | DXG | Class II | |
| K212169 | Air compression therapy system FO3002 | Foshan Hongfeng Co.,Ltd | IRP | Class II | |
| K212150 | Exablate Prostate System | Insightec, Ltd. | PLP | Class II | |
| K212101 | da Vinci SP Firefly Imaging System | Intuitive Surgical, Inc. | NAY | Class II | |
| K211956 | 039 Surgical Face Mask | AOK Tooling Limited | FXX | Class II | |
| K211765 | Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown | Medtronic, Inc. | FYA | Class II | |
| K211649 | PCEA Syringe Set | Baxter Healthcare Corporation | PWH | Class II | |
| K211562 | Virtue RF | ShenB Co., Ltd. | GEI | Class II | |
| K211432 | Myomics Q | Phantomics, Inc. | LLZ | Class II | |
| K211387 | Breathe Easy Mobile Respiratory Monitor (MRM) | Sound Life Sciences, Inc. | BZQ | Class II | |
| K211347 | Uretero1 Ureteroscope System | STERIS Corporation | FGB | Class II | |
| K211342 | Sofia 2 Campylobacter FIA | Ortho-Clinical Diagnostics, Inc. | LQP | Class I | |
| K210095 | Playboy Premium Silicone Lubricant | Thai Nippon Rubber Industry Public Company Limited | NUC | Class II | |
| K203248 | Albumin BCG2 | Abbott Ireland Diagnostics Division | CIX | Class II | |
| K202445 | Hystero-V Hysteroscope | Hysterovue, Inc. | HIH | Class II | |
| DEN210012 | vPatch | Virility Medical Ltd. | QRC | Class II | |
| K213451 | Spartan MC 0165 | Spartan Micro, Inc. | QJP | Class II | |
| K212989 | Low-frequency Stimulator (Model: AST-645, AST-646) | Shenzhen Osto Technology Company Limited | NUH | Class II | |
| K211960 | Agile Esophageal OTW Stent System | Boston Scientific Corporation | ESW | Class II | |
| K211854 | VITA Akzent LC | Vita Zahnfabrik GmbH H Rauter & Co | EBD | Class II | |
| K211741 | Pre-Formed Extra Support Guidewire | Lake Region Medical | DQX | Class II | |
| K211651 | Eclipse PRO | GE Healthcare | MWJ | Class II | |
| K211168 | Philips Incisive CT on Trailer | Philips Healthcare (Suzhou) Co., Ltd. | JAK | Class II | |
| K210990 | Non-sterile Powder Free Nitrile Examination Gloves | Rubberex Alliance Sdn Bhd | LZA | Class I |