Cleared Traditional

K012678 - REPROCESSED SEALED ELECTROPHYSIOLOGY DI...

K012678 is the FDA 510(k) clearance for REPROCESSED SEALED ELECTROPHYSIOLOGY DI... by Sterilmed, Inc.. It is a Class 2 Cardiovascular device (product code NLH) cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K012678 · Sterilmed, Inc. · Cardiovascular device
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Aug 2002
Decision
365d
Days
Class 2
Risk

K012678 is an FDA 510(k) clearance for the REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS. Classified as Catheter, Recording, Electrode, Reprocessed (product code NLH), Class II - Special Controls.

Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on August 14, 2002 after a review of 365 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 Sterilmed, Inc. devices

Submission Details

510(k) Number K012678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date August 14, 2002
Days to Decision 365 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
240d slower than avg
Panel avg: 125d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K012678.
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K023180 · Vanguard Medical Concepts, Inc. · Dec 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K022316 · Vanguard Medical Concepts, Inc. · Oct 2002
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K012523 · Sterilmed, Inc. · Aug 2002
ELECTROPHYSIOLOGY CATHETER
K012708 · Alliance Medical Corp. · Aug 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K012687 · Vanguard Medical Concepts, Inc. · Aug 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K012688 · Vanguard Medical Concepts, Inc. · Jul 2002