Cleared Special

K122172 - SYSTEM 83 PLUS

K122172 is the FDA 510(k) clearance for SYSTEM 83 PLUS by Custom Ultrasonics. It is a Class 2 General Hospital device (product code FEB) cleared through the Special 510(k) pathway after a 186-day FDA review.

K122172 · Custom Ultrasonics · General Hospital
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Jan 2013
Decision
186d
Days
Class 2
Risk

K122172 is an FDA 510(k) clearance for the SYSTEM 83 PLUS. Classified as Accessories, Cleaning, For Endoscope (product code FEB), Class II - Special Controls.

Submitted by Custom Ultrasonics (Ivyland, US). The FDA issued a Cleared decision on January 25, 2013 after a review of 186 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Custom Ultrasonics devices

Submission Details

510(k) Number K122172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2012
Decision Date January 25, 2013
Days to Decision 186 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 129d · This submission: 186d
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 26
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