Cleared Traditional

PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 (K993414) - FDA 510(k) Clearance

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

K993414 · Prucka Engineering, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
178d
Days
Class 2
Risk

K993414 is an FDA 510(k) clearance for the PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Prucka Engineering, Inc. (Sugarland, US). The FDA issued a Cleared decision on April 7, 2000 after a review of 178 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Prucka Engineering, Inc. devices

Submission Details

510(k) Number K993414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1999
Decision Date April 07, 2000
Days to Decision 178 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
53d slower than avg
Panel avg: 125d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 119
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K993414.
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K001492 · Quinton, Inc. · Aug 2000
M1765A ECG MANAGER
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NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH
K972310 · Nihon Kohden America, Inc. · Aug 1997
SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)
K964784 · Quinton, Inc. · Aug 1997