Cleared Traditional

LimFlow V-Ceiver (K222083) - FDA 510(k) Clearance

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

K222083 · LimFlow, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2022
Decision
25d
Days
Class 2
Risk

K222083 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. (San Jose, US). The FDA issued a Cleared decision on August 9, 2022 after a review of 25 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 LimFlow, Inc. devices

Submission Details

510(k) Number K222083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2022
Decision Date August 09, 2022
Days to Decision 25 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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

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 K222083.
LimFlow V-Ceiver
K242776 · LimFlow, Inc. · Feb 2025
Amplatz Goose Neck Snare Kit
K241259 · Medtronic, Inc. · Jun 2024
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
K232443 · Argon Medical Devices, Inc. · Sep 2023
Gunther Tulip Vena Cava Filter Retrieval Set
K222254 · Cook Incorporated · May 2023
ONO Retrieval Device
K212988 · Onocor Vascular, LLC · May 2022
Aveir Retrieval Catheter
K213494 · Abbott Medical · Apr 2022