Cleared Traditional

K252042 - Sync AV II Temporary Pacing Catheter

K252042 is an FDA 510(k) clearance for Sync AV II Temporary Pacing Catheter, manufactured by Swift Sync, Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 395-day FDA review.

K252042 · Swift Sync, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
395d
Days
Class 2
Risk

K252042 is an FDA 510(k) clearance for the Sync AV II Temporary Pacing Catheter. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Swift Sync, Inc. (Miami Shores, US). The FDA issued a Cleared decision on July 30, 2026 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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. Elevated predicate reliance profile. 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 Swift Sync, Inc. devices

FDA 510(k) Submission Details - K252042

510(k) Number K252042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2025
Decision Date July 30, 2026
Days to Decision 395 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
270d slower than avg
Panel avg: 125d · This submission: 395d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDF Device Classification - Class 2, Special Controls

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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 - LDF Electrode, Pacemaker, Temporary

All 83
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K252042.
Bioptimal Bipolar Pacing Catheter
K242863 · Bioptimal International Pte. , Ltd. · Jun 2025
Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
K251186 · C.R. Bard, Inc. · May 2025
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P)
K241334 · C.R. Bard, Inc. · Jan 2025
Rotatable Connector (5944RL)
K241199 · Shenzhen Launch Electrical Co., Ltd. · Jan 2025
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
K242705 · Medtronic, Inc. · Jan 2025
TME Temporary Myocardial Electrode
K232261 · Osypka AG · Apr 2024