Cleared Traditional

K241562 - OutFlo Aortic Valve Dilatation Balloon Catheter (FDA 510(k) Clearance)

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

K241562 · Disa Medinotec · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2025
Decision
284d
Days
Class 2
Risk

K241562 is an FDA 510(k) clearance for the OutFlo Aortic Valve Dilatation Balloon Catheter. Classified as Balloon Aortic Valvuloplasty (product code OZT), Class II - Special Controls.

Submitted by Disa Medinotec (Johannesburg, ZA). The FDA issued a Cleared decision on March 11, 2025 after a review of 284 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1255 - 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 Disa Medinotec devices

Submission Details

510(k) Number K241562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2024
Decision Date March 11, 2025
Days to Decision 284 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
159d slower than avg
Panel avg: 125d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OZT Balloon Aortic Valvuloplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1255
Definition A Balloon Aortic Valvuloplasty Catheter Is Indicated For Balloon Valvuloplasty Of The Aortic Valve.
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

Biologics Consulting Group
Matthew Krueger

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 - OZT Balloon Aortic Valvuloplasty

All 20
Devices cleared under the same product code (OZT) and FDA review panel - the closest regulatory comparables to K241562.
Valvuloplasty Balloon Catheter (ValvuloPro)
K260437 · Dongguan TT Medical, Inc. · Mar 2026
ValvuloPro Valvuloplasty Balloon Catheter
K240967 · Dongguan TT Medical, Inc. · Jul 2024
ValvuloPro Valvuloplasty Balloon Catheter
K231814 · Dongguan TT Medical, Inc. · Oct 2023
INOUE BALLOON A
K220881 · Toray Industries, Inc. · Dec 2022