Cleared Special

K242776 - LimFlow V-Ceiver (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K242776 · LimFlow, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
154d
Days
Class 2
Risk

K242776 is an FDA 510(k) clearance for the LimFlow V-Ceiver. Classified as Device, Percutaneous Retrieval (product code MMX), Class II - Special Controls.

Submitted by LimFlow, Inc. (Irvine, US). The FDA issued a Cleared decision on February 14, 2025 after a review of 154 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all LimFlow, Inc. devices

Submission Details

510(k) Number K242776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2024
Decision Date February 14, 2025
Days to Decision 154 days
Submission Type Special
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
29d slower than avg
Panel avg: 125d · This submission: 154d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Peers - MMX Device, Percutaneous Retrieval

All 31
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