Cleared Traditional

DIAGNOSTIC II CATHETER (K940168) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K940168 · Ep Technologies, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 1994
Decision
201d
Days
Class 2
Risk

K940168 is an FDA 510(k) clearance for the DIAGNOSTIC II CATHETER. 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 July 27, 1994 after a review of 201 days - an extended review cycle.

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 Ep Technologies, Inc. devices

Submission Details

510(k) Number K940168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1994
Decision Date July 27, 1994
Days to Decision 201 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
76d slower than avg
Panel avg: 125d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 50
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K940168.
ELECTRODE RECORDING CATHETER
K954651 · Boston Scientific Corp · Oct 1996
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
K953750 · Boston Scientific Corp · Mar 1996
LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS
K951744 · Boston Scientific Corp · May 1995
EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC
K924163 · Boston Scientific Corp · Sep 1993
MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES
K914460 · Medtronic Vascular · Nov 1991
BARD(R) ENDOCARDIAL BALLOON ARRAY
K911140 · C.R. Bard, Inc. · May 1991