Cleared Traditional

K171880 - IRRAflow CNS System

K171880 is an FDA 510(k) clearance for IRRAflow CNS System, manufactured by Irras, Inc.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K171880 · Irras, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
385d
Days
Class 2
Risk

K171880 is an FDA 510(k) clearance for the IRRAflow CNS System. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Irras, Inc. (La Jolla, US). The FDA issued a Cleared decision on July 13, 2018 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - the FDA neurology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Irras, Inc. devices

FDA 510(k) Submission Details - K171880

510(k) Number K171880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2017
Decision Date July 13, 2018
Days to Decision 385 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
237d slower than avg
Panel avg: 148d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 Neurology devices follow this clearance model.

Regulatory Peers - JXG Shunt, Central Nervous System And Components

All 207
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K171880.
CodMan Certas Plus Programmable Valve
K182265 · Integra Lifesciences Corp. · Nov 2018
Codman Certas Plus Electronic Tool Kit
K181902 · Integra Lifesciences Corp. · Oct 2018
StrataMR guider tool
K181622 · Medtronic Neurosurgery · Oct 2018
Smart External Drain (SED) System
K181301 · Aqueduct Critical Care, Inc. · Jun 2018
EKOS ultrasound EVD Device, EVD Control Unit
K172035 · Btg International, Inc. · Mar 2018
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
K172537 · Codman & Shurtleff, Inc. · Oct 2017