Cleared Traditional

K862122 - S-CAL HEMATOLOGY CALIBRATOR (FDA 510(k) Clearance)

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

K862122 · Coulter Electronics, Inc. · Hematology device
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May 1987
Decision
351d
Days
Class 2
Risk

K862122 is an FDA 510(k) clearance for the S-CAL HEMATOLOGY CALIBRATOR. Classified as Calibrator For Platelet Counting (product code KRY), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on May 20, 1987 after a review of 351 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8175 - 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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K862122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1986
Decision Date May 20, 1987
Days to Decision 351 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
238d slower than avg
Panel avg: 113d · This submission: 351d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRY Calibrator For Platelet Counting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8175
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.