Cleared Traditional

K862122 - S-CAL HEMATOLOGY CALIBRATOR

K862122 is an FDA 510(k) clearance for S-CAL HEMATOLOGY CALIBRATOR, manufactured by Coulter Electronics, Inc.. The device is a Class 2 Hematology device with product code KRY cleared through the Traditional 510(k) pathway after a 351-day FDA review.

K862122 · Coulter Electronics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K862122

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
Combination Product No
PCCP Authorized No
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.

KRY Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KRY Calibrator For Platelet Counting

Devices cleared under the same product code (KRY) and FDA review panel - the closest regulatory comparables to K862122.
LASER PLATELETCAL/MULTIPLE
K852016 · R&D Systems, Inc. · Jul 1985
COULTER MEAN PLATELET VOLUME CALIBRATOR
K843910 · Coulter Electronics, Inc. · Jan 1985
S-CAL HEMATOLOGY CALIBRATOR
K840794 · Coulter Electronics, Inc. · Apr 1984
TEKNI-CAL
K781601 · Streck Laboratories, Inc. · Oct 1978
PC-CALIBRATOR
K781133 · Streck Laboratories, Inc. · Aug 1978
TQC CALIBRATION REFERENCE FOR PLATELETS
K770143 · Technicon Instruments Corp. · Jan 1978