Cleared Traditional

K163031 - Bunegin-Albin Air Aspiration Set

K163031 is an FDA 510(k) clearance for Bunegin-Albin Air Aspiration Set, manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K163031 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
269d
Days
Class 2
Risk

K163031 is an FDA 510(k) clearance for the Bunegin-Albin Air Aspiration Set. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 27, 2017 after a review of 269 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cook Incorporated devices

FDA 510(k) Submission Details - K163031

510(k) Number K163031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2016
Decision Date July 27, 2017
Days to Decision 269 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 125d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXE Device Classification - Class 2, Special Controls

Product Code DXE Catheter, Embolectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXE Catheter, Embolectomy

All 40
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K163031.
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