Cleared Traditional

Imperative Care Radial 088 Access System (K220807) - FDA 510(k) Clearance

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

K220807 · Imperative Care, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
60d
Days
Class 2
Risk

K220807 is an FDA 510(k) clearance for the Imperative Care Radial 088 Access System. Classified as Catheter, Percutaneous, Neurovasculature (product code QJP), Class II - Special Controls.

Submitted by Imperative Care, Inc. (Campbell, US). The FDA issued a Cleared decision on May 17, 2022 after a review of 60 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 Imperative Care, Inc. devices

Submission Details

510(k) Number K220807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2022
Decision Date May 17, 2022
Days to Decision 60 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
88d faster than avg
Panel avg: 148d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QJP Catheter, Percutaneous, Neurovasculature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures
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 - QJP Catheter, Percutaneous, Neurovasculature

All 90
Devices cleared under the same product code (QJP) and FDA review panel - the closest regulatory comparables to K220807.
Minjie Catheter System
K212288 · Kai Medtech, LLC · Jun 2022
Distal Access Catheter
K213065 · Guangzhou Easycess Medical Co.,Ltd · May 2022
Benchmark Intracranial Access System
K212838 · Penumbra, Inc. · May 2022
Bendit21 Microcatheter
K203842 · Bend IT Technologies, Ltd. · Apr 2022
FUBUKI XF Neurovascular Long Sheath
K213589 · Asahi Intecc Co., Ltd. · Mar 2022
CerusEndo Microcatheter (027)
K213314 · Cerus Endovascular, Inc. · Mar 2022