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
NCT06261788
Completed
Interventional
Industry-sponsored
Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter
Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter (EASY II Trial)
| Condition studied |
Heart Block; Valve Heart Disease |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
|
| Sponsor |
Swift Sync, Inc.
(industry)
|
Started 2023-06-01
→
Primary completion 2023-09-13
→
Completed 2023-09-26
Primary outcome
With a commercially available pacing box and/or analyzer, measure the ventricular pacing threshold at 24 hours post implant of the investigational device (index procedure)
Study completed - no results published.
This trial concluded in 2023 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov