Cleared Traditional

K894631 - NKA MODEL MFV-3100 & MFV-3200 ELECTRO. ...

K894631 is an FDA 510(k) clearance for NKA MODEL MFV-3100 & MFV-3200 ELECTRO. ..., manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K894631 · Nihon Kohden America, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1990
Decision
179d
Days
Class 2
Risk

K894631 is an FDA 510(k) clearance for the NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on January 19, 1990 after a review of 179 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - 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 - K894631

510(k) Number K894631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date January 19, 1990
Days to Decision 179 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
54d slower than avg
Panel avg: 125d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPW Device Classification - Class 2, Special Controls

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 - DPW Flowmeter, Blood, Cardiovascular

All 34
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K894631.
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG
K913827 · Hewlett-Packard Co. · Nov 1991
ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER
K901335 · Ge Medical Systems Information Technologies · Aug 1990
MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND
K902088 · Hewlett-Packard Co. · Aug 1990
COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION
K871490 · Ge Medical Systems Information Technologies · Dec 1987
HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD
K872068 · Advanced Technology Laboratories, Inc. · Sep 1987
HIGH VELOCITY CW DOPPLER SYSTEM
K862841 · Biosound, Inc. · Nov 1986