Cleared Traditional

K100254 - REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC...

K100254 is the FDA 510(k) clearance for REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC... by Ascent Healthcare Solutions. It is a Class 2 Cardiovascular device (product code NLH) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K100254 · Ascent Healthcare Solutions · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
120d
Days
Class 2
Risk

K100254 is an FDA 510(k) clearance for the REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER. Classified as Catheter, Recording, Electrode, Reprocessed (product code NLH), Class II - Special Controls.

Submitted by Ascent Healthcare Solutions (Phoenix, US). The FDA issued a Cleared decision on May 28, 2010 after a review of 120 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 Ascent Healthcare Solutions devices

Submission Details

510(k) Number K100254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2010
Decision Date May 28, 2010
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
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 52
Devices cleared under the same product code (NLH) and FDA review panel - the closest regulatory comparables to K100254.
Reprocessed Electrophysiology Diagnostic Catheters
K150357 · Sterilmed, Inc. · Aug 2015
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K121158 · Sterilmed, Inc. · Aug 2012
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K101789 · Sterilmed, Inc. · Aug 2010
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K092158 · Sterilmed, Inc. · Jan 2010
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K061045 · Alliance Medical Corp. · Aug 2006
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K052414 · Alliance Medical Corp. · Nov 2005