Cleared Traditional

K171880 - IRRAflow CNS System

K171880 is the FDA 510(k) clearance for IRRAflow CNS System by Irras, Inc.. It is a Class 2 Neurology device (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

Submission Details

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.

Device Classification

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 117
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