Cleared Traditional

K243598 - Welch Allyn Connex® 360 (Multiple) (FDA 510(k) Clearance)

K243598 · Welch Allyn, Inc. · Cardiovascular device
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Jul 2025
Decision
234d
Days
-
Risk

K243598 is an FDA 510(k) clearance for the Welch Allyn Connex® 360 (Multiple).

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 13, 2025 after a review of 234 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel. 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 Welch Allyn, Inc. devices

Submission Details

510(k) Number K243598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2024
Decision Date July 13, 2025
Days to Decision 234 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
109d slower than avg
Panel avg: 125d · This submission: 234d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -