Cleared Traditional

K894492 - NKA MODEL SEC-3102 CARDIAC STIMULATOR

K894492 is an FDA 510(k) clearance for NKA MODEL SEC-3102 CARDIAC STIMULATOR, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K894492 · Nihon Kohden America, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
155d
Days
Class 2
Risk

K894492 is an FDA 510(k) clearance for the NKA MODEL SEC-3102 CARDIAC STIMULATOR. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on December 20, 1989 after a review of 155 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K894492

510(k) Number K894492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1989
Decision Date December 20, 1989
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRO Device Classification - Class 2, Special Controls

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
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 - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 36
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K894492.
K-DEFIB/PACE ELECTRODE
K914955 · Katecho, Inc. · May 1992
QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC
K912599 · Physio-Control Corp. · Sep 1991
MODEL 205 SHOCK-TRODE
K910661 · Cardiotronics, Inc. · May 1991
DEFIB/PACING PADS
K894588 · Conmedcorp · Oct 1989
TRIAD-EP II, PUSHBUTTON, CABLE INPUT
K884532 · Cardiotronics, Inc. · Nov 1988
TRIAD-EP II, PLATE INPUT
K884530 · Cardiotronics, Inc. · Nov 1988