Cleared Traditional

K091563 - RECRUIT MICROCATHETER

K091563 is an FDA 510(k) clearance for RECRUIT MICROCATHETER, manufactured by Reverse Medical Corporation. The device is a Class 2 Cardiovascular device with product code MMX cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K091563 · Reverse Medical Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
63d
Days
Class 2
Risk

K091563 is an FDA 510(k) clearance for the RECRUIT MICROCATHETER. Classified as Device, Percutaneous Retrieval (product code MMX), Class II - Special Controls.

Submitted by Reverse Medical Corporation (Irvine, US). The FDA issued a Cleared decision on July 30, 2009 after a review of 63 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.

FDA 510(k) Submission Details - K091563

510(k) Number K091563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2009
Decision Date July 30, 2009
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MMX Device Classification - Class 2, Special Controls

Product Code MMX Device, Percutaneous Retrieval
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 - MMX Device, Percutaneous Retrieval

All 31
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K091563.
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