Cleared Traditional

APRO 55 Catheter and Alembic Aspiration Tubing (K232971) - FDA 510(k) Clearance

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

K232971 · Alembic, LLC · Neurology device
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Feb 2024
Decision
161d
Days
Class 2
Risk

K232971 is an FDA 510(k) clearance for the APRO 55 Catheter and Alembic Aspiration Tubing. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Alembic, LLC (Mountain View, US). The FDA issued a Cleared decision on February 29, 2024 after a review of 161 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 Alembic, LLC devices

Submission Details

510(k) Number K232971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2023
Decision Date February 29, 2024
Days to Decision 161 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
13d slower than avg
Panel avg: 148d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NRY Catheter, Thrombus Retriever
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.
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 - NRY Catheter, Thrombus Retriever

All 72
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K232971.
Millipede 088 Access Catheter
K242504 · Perfuze, Ltd. · Sep 2024
Next Generation Aspiration Catheter
K234083 · Balt USA, LLC · Jul 2024
Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
K233329 · Route 92 Medical, Inc. · Apr 2024
Cerenovus Large Bore Catheter
K233988 · Cerenovus, Inc. · Jan 2024
Millipede 070 Aspiration Catheter
K232524 · Perfuze, Ltd. · Oct 2023
Socrates Aspiration System
K223913 · Scientia Vascular, Inc. · Sep 2023