Cleared Traditional

K924109 - STEEROCATH II

K924109 is an FDA 510(k) clearance for STEEROCATH II, manufactured by Ep Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 489-day FDA review.

K924109 · Ep Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
489d
Days
Class 2
Risk

K924109 is an FDA 510(k) clearance for the STEEROCATH II. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Ep Technologies, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 16, 1993 after a review of 489 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

FDA 510(k) Submission Details - K924109

510(k) Number K924109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1992
Decision Date December 16, 1993
Days to Decision 489 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
364d slower than avg
Panel avg: 125d · This submission: 489d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRF Device Classification - Class 2, Special Controls

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 182
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K924109.
DIAGNOSTIC II CATHETER
K940168 · Ep Technologies, Inc. · Jul 1994
MARINR SERIES EP DIAGNOSTIC CATHETERS
K931794 · Medtronic Cardiorhythm · Jun 1994
TRACFINDER II
K924108 · Ep Technologies, Inc. · Dec 1993
ENDOCATH ELECTROPHYSIOLOGY CATHETER
K926549 · Endo-Therapeutics, Inc. · Dec 1993
EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC
K924163 · Boston Scientific Corp · Sep 1993
TORQR SERIES DIAGNOSTIC EP CATHETERS
K923915 · Cardiorhythm · Feb 1993
K924109 · STEEROCATH II
Download PDF FDA Summary Ep Technologies, Inc.