Cleared Traditional

K121158 - REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS

K121158 is an FDA 510(k) clearance for REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTI..., manufactured by Sterilmed, Inc.. The device is a Class 2 Cardiovascular device with product code NLH cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K121158 · Sterilmed, Inc. · Cardiovascular device
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Aug 2012
Decision
112d
Days
Class 2
Risk

K121158 is an FDA 510(k) clearance for the REPROCESSED 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 6, 2012 after a review of 112 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

FDA 510(k) Submission Details - K121158

510(k) Number K121158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2012
Decision Date August 06, 2012
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
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 68
Devices cleared under the same product code (NLH) and FDA review panel - the closest regulatory comparables to K121158.
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K101789 · Sterilmed, Inc. · Aug 2010