Cleared Traditional

K050023 - SECURELOC

Also marketed or referenced as:
ADVANCINTRODUCER

K050023 is an FDA 510(k) clearance for SECURELOC, manufactured by Specialized Health Products, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K050023 · Specialized Health Products, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
44d
Days
Class 2
Risk

K050023 is an FDA 510(k) clearance for the SECURELOC. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Specialized Health Products, Inc. (Bountiful, US). The FDA issued a Cleared decision on February 18, 2005 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Specialized Health Products, Inc. devices

FDA 510(k) Submission Details - K050023

510(k) Number K050023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2005
Decision Date February 18, 2005
Days to Decision 44 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
81d faster than avg
Panel avg: 125d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 440
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K050023.
VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
K051248 · Vygon Corp. · Oct 2005
DESTINATION CAROTID GUIDING SHEATH
K052185 · Terumo Medical Corp. · Sep 2005
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K051601 · Terumo Medical Corp. · Aug 2005
LARGE BORE SPLITTABLE INTRODUCER KIT
K043438 · Thomas Medical Products, Inc. · Feb 2005
INTRAVASCULAR ACCESS INTRODUCER SHEATH
K041506 · Applied Medical Resources Corp. · Oct 2004
AIRGUARD VALVED INTRODUCER
K042036 · C.R. Bard, Inc. · Aug 2004