Cleared Traditional

K220331 - 091 Balloon Guide Catheter (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220331 · Inneuroco, Inc. · Neurology device
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Jul 2022
Decision
175d
Days
Class 2
Risk

K220331 is an FDA 510(k) clearance for the 091 Balloon Guide Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Inneuroco, Inc. (Pembroke Pines, US). The FDA issued a Cleared decision on July 29, 2022 after a review of 175 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - 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. Standard predicate reliance. 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 Inneuroco, Inc. devices

Submission Details

510(k) Number K220331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2022
Decision Date July 29, 2022
Days to Decision 175 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
27d slower than avg
Panel avg: 148d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 887
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K220331.
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