Cleared Special

K213833 - SCOPE BUDDY PLUS Endoscope Flushing Aid (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K213833 · Medivators, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
36d
Days
Class 2
Risk

K213833 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 January 14, 2022 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 876.1500 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medivators, Inc. devices

Submission Details

510(k) Number K213833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2021
Decision Date January 14, 2022
Days to Decision 36 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 128d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

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 56
Devices cleared under the same product code (FEB) and FDA review panel - the closest regulatory comparables to K213833.
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