Cleared Traditional

K232067 - Defendo Fujifilm 500/600 Single Use Air...

K232067 is an FDA 510(k) clearance for Defendo Fujifilm 500/600 Single Use Air..., manufactured by Medivators (A Subsidiary of Steris Corporation). The device is a Class 2 Gastroenterology & Urology device with product code ODC cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K232067 · Medivators (A Subsidiary of Steris Corporation) · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2024
Decision
255d
Days
Class 2
Risk

K232067 is an FDA 510(k) clearance for the Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600.... Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Medivators (A Subsidiary of Steris Corporation) (Conroe, US). The FDA issued a Cleared decision on March 22, 2024 after a review of 255 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medivators (A Subsidiary of Steris Corporation) devices

FDA 510(k) Submission Details - K232067

510(k) Number K232067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2023
Decision Date March 22, 2024
Days to Decision 255 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 130d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODC Device Classification - Class 2, Special Controls

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - ODC Endoscope Channel Accessory

All 50
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K232067.
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)
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K242742 · STERIS Corporation · Oct 2024
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K241285 · Alton (Shanghai) Medical Instruments Co., Ltd. · Oct 2024
Endorail
K232327 · Endostart S.R.L. · Mar 2024
Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector
K232004 · Medivators (A Subsidiary of Steris Corporation) · Mar 2024
Defendo Single Use Cleaning Adapter for Olympus Endoscopes
K240352 · STERIS Corporation · Mar 2024