Cleared Traditional

K070254 - HORIZON SE

K070254 is an FDA 510(k) clearance for HORIZON SE, manufactured by Mennen Medical , Ltd.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K070254 · Mennen Medical , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
83d
Days
Class 2
Risk

K070254 is an FDA 510(k) clearance for the HORIZON SE. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Mennen Medical , Ltd. (Yavne, IL). The FDA issued a Cleared decision on April 19, 2007 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mennen Medical , Ltd. devices

FDA 510(k) Submission Details - K070254

510(k) Number K070254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2007
Decision Date April 19, 2007
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

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 280
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K070254.
EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM
K071348 · Mennen Medical , Ltd. · Sep 2007
CARTO XP EP NAVIGATION SYSTEM, VERSION 9
K070240 · Biosense Webster, Inc. · May 2007
MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
K070902 · St Jude Medical · May 2007
SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
K063490 · Spacelabs Medical, Inc. · Mar 2007
MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM
K061741 · Ge Healthcare · Sep 2006
NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE
K053194 · Biosense Webster, Inc. · Mar 2006