Cleared Traditional

K903026 - ES-1000SP II SMART DOP

K903026 is an FDA 510(k) clearance for ES-1000SP II SMART DOP, manufactured by Koven and Assoc., Inc.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K903026 · Koven and Assoc., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1991
Decision
231d
Days
Class 2
Risk

K903026 is an FDA 510(k) clearance for the ES-1000SP II SMART DOP. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Koven and Assoc., Inc. (St. Louis, US). The FDA issued a Cleared decision on February 26, 1991 after a review of 231 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 Koven and Assoc., Inc. devices

FDA 510(k) Submission Details - K903026

510(k) Number K903026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1990
Decision Date February 26, 1991
Days to Decision 231 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 125d · This submission: 231d
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 81
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K903026.
MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG
K913827 · Hewlett-Packard Co. · Nov 1991
INTERSPEC APOGEE, MODIFICATION
K910049 · Interspec, Inc. · Apr 1991
FLOWIRE AND FLOMAP
K905411 · Cardio Metrics, Inc. · Mar 1991
DOPPLER NEEDLE AND FLOW MONITOR
K903625 · Peripheral Systems Group · Nov 1990
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