Cleared Traditional

InstaFAN

K251542 · Onepass Medical , Ltd. · Gastroenterology & Urology

Jul 2025

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K251542 is an FDA 510(k) clearance for the InstaFAN, a Endoscopic Ultrasound System, Gastroenterology-urology (Class II — Special Controls, product code ODG), submitted by Onepass Medical , Ltd. (Katzrin, IL). The FDA issued a Cleared decision on July 18, 2025, 59 days after receiving the submission on May 20, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K251542 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 2025
Decision Date	July 18, 2025
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	ODG — Endoscopic Ultrasound System, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Provide Ultrasonic Visualization Of Body Cavities That Can Be Accessed By Endoscope. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).