Cleared Traditional

K830441 - DIFF 4 SYSTEM

K830441 is an FDA 510(k) clearance for DIFF 4 SYSTEM, manufactured by Coulter Electronics, Inc.. The device is a Class 2 Hematology device with product code EKZ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K830441 · Coulter Electronics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1983
Decision
95d
Days
Class 2
Risk

K830441 is an FDA 510(k) clearance for the DIFF 4 SYSTEM. Classified as Unit, Electrosurgical, And Accessories, Dental (product code EKZ), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Walker, US). The FDA issued a Cleared decision on May 16, 1983 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 872.4920 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Coulter Electronics, Inc. devices

FDA 510(k) Submission Details - K830441

510(k) Number K830441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1983
Decision Date May 16, 1983
Days to Decision 95 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 113d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EKZ Device Classification - Class 2, Special Controls

Product Code EKZ Unit, Electrosurgical, And Accessories, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4920
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 Hematology devices follow this clearance model.