Cleared Traditional

K101685 - IP-SET

K101685 is an FDA 510(k) clearance for IP-SET, manufactured by Integral Process Sas. The device is a Class 2 Cardiovascular device with product code DRX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K101685 · Integral Process Sas · Cardiovascular device
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Jul 2010
Decision
15d
Days
Class 2
Risk

K101685 is an FDA 510(k) clearance for the IP-SET. Classified as Electrode, Electrocardiograph (product code DRX), Class II - Special Controls.

Submitted by Integral Process Sas (Conflans Sainte Honorine, FR). The FDA issued a Cleared decision on July 1, 2010 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2360 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Integral Process Sas devices

FDA 510(k) Submission Details - K101685

510(k) Number K101685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2010
Decision Date July 01, 2010
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DRX Device Classification - Class 2, Special Controls

Product Code DRX Electrode, Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2360
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 - DRX Electrode, Electrocardiograph

All 131
Devices cleared under the same product code (DRX) and FDA review panel - the closest regulatory comparables to K101685.
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