Cleared Traditional

K161272 - Supreme and Response Electrophysiology ...

K161272 is the FDA 510(k) clearance for Supreme and Response Electrophysiology ... by Surgical Instrument Service and Savings, Inc.. It is a Class 2 Cardiovascular device (product code NLH) cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K161272 · Surgical Instrument Service and Savings, Inc. · Cardiovascular device
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May 2017
Decision
378d
Days
Class 2
Risk

K161272 is an FDA 510(k) clearance for the Supreme and Response Electrophysiology Catheters. Classified as Catheter, Recording, Electrode, Reprocessed (product code NLH), Class II - Special Controls.

Submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on May 18, 2017 after a review of 378 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 Surgical Instrument Service and Savings, Inc. devices

Submission Details

510(k) Number K161272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2016
Decision Date May 18, 2017
Days to Decision 378 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
253d slower than avg
Panel avg: 125d · This submission: 378d
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 K161272.
Reprocessed Halo XP Diagnostic Electrophysiology Catheter
K171788 · Innovative Health, LLC · Nov 2017
Reprocessed CristaCath Diagnostic Electrophysiology Catheter
K171503 · Innovative Health, LLC · Oct 2017
Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)
K170922 · Innovative Health, LLC · Jun 2017
Reprocessed Viking Diagnostic Electrophysiology Catheters
K162251 · Innovative Health, LLC · Dec 2016
Reprocessed Response Diagnostic Electrophysiology Catheters
K161827 · Innovative Health, LLC · Dec 2016
Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter
K160421 · Innovative Health, LLC · Nov 2016