Cleared Traditional

K212988 - ONO Retrieval Device

K212988 is an FDA 510(k) clearance for ONO Retrieval Device, manufactured by Onocor Vascular, LLC. The device is a Class 2 Cardiovascular device with product code MMX cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K212988 · Onocor Vascular, LLC · Cardiovascular device
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May 2022
Decision
245d
Days
Class 2
Risk

K212988 is an FDA 510(k) clearance for the ONO Retrieval Device. Classified as Device, Percutaneous Retrieval (product code MMX), Class II - Special Controls.

Submitted by Onocor Vascular, LLC (West Chester, US). The FDA issued a Cleared decision on May 23, 2022 after a review of 245 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Onocor Vascular, LLC devices

FDA 510(k) Submission Details - K212988

510(k) Number K212988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2021
Decision Date May 23, 2022
Days to Decision 245 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
120d slower than avg
Panel avg: 125d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - MMX Device, Percutaneous Retrieval

All 22
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K212988.
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
LimFlow V-Ceiver
K222083 · LimFlow, Inc. · Aug 2022
Aveir Retrieval Catheter
K213494 · Abbott Medical · Apr 2022
Halo Single-Loop Microsnare Kit
K200963 · Argon Medical Devices, Inc. · Jan 2021
Halo™ Single-Loop Snare Kit
K200268 · Argon Medical Devices, Inc. · Jun 2020