Cleared Special

K192155 - Smith & Nephew DYONICS 25 Fluid Management System

K192155 is an FDA 510(k) clearance for Smith & Nephew DYONICS 25 Fluid Managem..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 General & Plastic Surgery device with product code HRX cleared through the Special 510(k) pathway after a 26-day FDA review.

K192155 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
26d
Days
Class 2
Risk

K192155 is an FDA 510(k) clearance for the Smith & Nephew DYONICS 25 Fluid Management System. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on September 4, 2019 after a review of 26 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 888.1100 - the FDA general and plastic surgery 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.

FDA 510(k) Submission Details - K192155

510(k) Number K192155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2019
Decision Date September 04, 2019
Days to Decision 26 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 684
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K192155.
Smith+Nephew Arthroscopes
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K191596 · Merit Medical Systems, Inc. · Oct 2019
Pegasus System
K191345 · A.M. Surgical, Inc. · Jul 2019
Stryker CrossFlow Integrated Arthroscopy Pump
K191259 · Stryker Corp. · Jul 2019
Voyant System
K191579 · Viseon, Inc. · Jul 2019
K192155 · Smith & Nephew DYONICS 25 Fluid Management System
Download PDF FDA Summary Smith & Nephew, Inc.