Cleared Special

K192155 - Smith & Nephew DYONICS 25 Fluid Managem...

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

K192155 · Smith & Nephew, Inc. · General & Plastic Surgery device
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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.

View all Smith & Nephew, Inc. devices

Submission Details

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.

Device Classification

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 376
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K192155.
Smith+Nephew Arthroscopes
K201349 · Smith & Nephew · Jul 2020
HydroCision SpineJet System
K200729 · Hydrocision, Inc. · Apr 2020
Arcadia Balloon Catheter
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