Cleared Traditional

K223545 - APRO 70 Catheter and Alembic Aspiration Tubing (FDA 510(k) Clearance)

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

K223545 · Alembic, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
84d
Days
Class 2
Risk

K223545 is an FDA 510(k) clearance for the APRO 70 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 17, 2023 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alembic, LLC devices

Submission Details

510(k) Number K223545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2022
Decision Date February 17, 2023
Days to Decision 84 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
64d faster than avg
Panel avg: 148d · This submission: 84d
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 105
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K223545.
Millipede System
K253590 · Perfuze, Ltd. · Mar 2026
Tigertriever 25 Revascularization Device
K253062 · Rapid Medical , Ltd. · Mar 2026
Esperance pHLO Aspiration System
K251357 · Phenox, Ltd. · Jan 2026
NeVasc Aspiration System
K251006 · Vesalio, Inc. · Nov 2025
Zoom System (Zoom 4S Catheter)
K252046 · Imperative Care, Inc. · Oct 2025
Tigertriever 17 Ultra Revascularization Device
K251603 · Rapid Medical , Ltd. · Oct 2025