Cleared Traditional

K233326 - Merge Hemo

K233326 is the FDA 510(k) clearance for Merge Hemo by Merge Healthcare Incorporated. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K233326 · Merge Healthcare Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
266d
Days
Class 2
Risk

K233326 is an FDA 510(k) clearance for the Merge Hemo, Model RCSV2. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Merge Healthcare Incorporated (Hartland, US). The FDA issued a Cleared decision on June 21, 2024 after a review of 266 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 Merge Healthcare Incorporated devices

Submission Details

510(k) Number K233326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date June 21, 2024
Days to Decision 266 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
141d slower than avg
Panel avg: 125d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 251
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