Cleared Traditional

K012687 - VANGUARD REPROCESSED DIAGNOSTIC ELECTRO...

K012687 is an FDA 510(k) clearance for VANGUARD REPROCESSED DIAGNOSTIC ELECTRO..., manufactured by Vanguard Medical Concepts, Inc.. The device is a Class 2 Cardiovascular device with product code NLH cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K012687 · Vanguard Medical Concepts, Inc. · Cardiovascular device
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Aug 2002
Decision
352d
Days
Class 2
Risk

K012687 is an FDA 510(k) clearance for the VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS. Classified as Catheter, Recording, Electrode, Reprocessed (product code NLH), Class II - Special Controls.

Submitted by Vanguard Medical Concepts, Inc. (Lakeland, US). The FDA issued a Cleared decision on August 1, 2002 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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 Vanguard Medical Concepts, Inc. devices

FDA 510(k) Submission Details - K012687

510(k) Number K012687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date August 01, 2002
Days to Decision 352 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
227d slower than avg
Panel avg: 125d · This submission: 352d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NLH Device Classification - Class 2, Special Controls

Product Code NLH Catheter, Recording, Electrode, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
Definition Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
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 - NLH Catheter, Recording, Electrode, Reprocessed

All 62
Devices cleared under the same product code (NLH) and FDA review panel - the closest regulatory comparables to K012687.
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K012523 · Sterilmed, Inc. · Aug 2002
REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K012678 · Sterilmed, Inc. · Aug 2002
ELECTROPHYSIOLOGY CATHETER
K012708 · Alliance Medical Corp. · Aug 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K012688 · Vanguard Medical Concepts, Inc. · Jul 2002