Cleared Traditional

Scope Buddy Plus Endoscope Flushing Aid (K162128) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162128 · Medivators, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 2016
Decision
142d
Days
Class 2
Risk

K162128 is an FDA 510(k) clearance for the Scope Buddy Plus Endoscope Flushing Aid. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Medivators, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 21, 2016 after a review of 142 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.1500 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medivators, Inc. devices

Submission Details

510(k) Number K162128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2016
Decision Date December 21, 2016
Days to Decision 142 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 129d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FEB Accessories, Cleaning, For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type 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).
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 General Hospital devices follow this clearance model.

Regulatory Peers - FEB Accessories, Cleaning, For Endoscope

All 12
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K162128.
ENDOSCOPE REPROCESSOR OER-Elite
K190969 · Olympus Medical Systems Corp. · Jul 2019
AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
K181472 · Advanced Sterilization Products (Asp) · Apr 2019
Acu-sInQ Complete Endoscope Cleaning Aid System
K181865 · STERIS Corporation · Dec 2018
RIWO SYSTEM TRAYS
K012309 · Richard Wolf Medical Instruments Corp. · Oct 2001
EW-10 AND EW-20
K915402 · Olympus Corp. · Jun 1995
AUTO SUTURE* ANTI-FOG DEVICE**
K944249 · United States Surgical, A Division of Tyco Healthc · Sep 1994