Cleared Traditional

CAPERE Thrombectomy System (K180722) - FDA 510(k) Clearance

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

K180722 · Kp Medcure, Inc. · Cardiovascular device
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Jun 2018
Decision
84d
Days
Class 2
Risk

K180722 is an FDA 510(k) clearance for the CAPERE Thrombectomy System. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Kp Medcure, Inc. (Anaheim, US). The FDA issued a Cleared decision on June 11, 2018 after a review of 84 days - a notably fast clearance 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: 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 Kp Medcure, Inc. devices

Submission Details

510(k) Number K180722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2018
Decision Date June 11, 2018
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration.
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 Consultant

Hogan Lovells US LLP
Janice M. Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 120
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K180722.
ClotTriever Thrombectomy System
K182531 · Inari Medical · Oct 2018
FlowTriever Retrieval/Aspiration System
K181694 · Inari Medical · Jul 2018
FlowTriever Retrieval/Aspiration System
K181325 · Inari Medical, Inc. · Jun 2018
FlowTriever Retrieval/Aspiration System
K180466 · Inari Medical, Inc. · May 2018
Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister
K180412 · Penumbra, Inc. · May 2018
Indigo Aspiration System - Modified 110 Aspiration Tubing
K180939 · Penumbra, Inc. · May 2018